Rheumatoid ArthritisPhase 3FLEX MNCT01198002

A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

A Phase 3 study testing LY2127399 and Methotrexate in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 234 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate. This study is comprised of 3 periods: Period 1: 52-week blinded treatment Period 2: additional 48-week unblinded treatment Period 3: 48-week… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: LY2127399 and Methotrexate
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,041 participants
Where: 234 sitesin 23 countries
Study dates: Dec 2010to Jan 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
At least 8 tender and swollen joints
At least one erosion of a hand or foot joint observed on an X-ray
An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
Woman must not be pregnant, breastfeeding, or become pregnant during the study

Who cannot join

Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks
Steroid injection or intravenous (iv) infusion in the last 6 weeks
Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
History of a serious reaction to other biological DMARDs
History of the use of rituximab or other B cell therapy

Show all 19Show fewer

Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
Hepatitis or human immunodeficiency virus (HIV)
A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
Symptoms of herpes zoster or herpes simplex within the last month
Active or latent tuberculosis (TB)
Current symptoms of a serious disorder or illness
Use of an investigational drug within the last month
History of the use of rituximab, any other B cell targeted biotherapy, or denosumab

Trial locations and contacts

234 sites in 23 countries.

Country

City, postcode or hospital

234 sites in 23 countries

United States75 sites

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Albuquerque, New Mexico, 87108
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Atlanta, Georgia, 30342
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Austin, Texas, 78731
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Aventura, Florida, 33180
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Bingham Farms, Michigan, 48025
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Birmingham, Alabama, 35216
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Boynton Beach, Florida, 33472
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Brooklyn, New York, 11201
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Charlotte, North Carolina, 28210
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Cincinnati, Ohio, 45242
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Cleveland, Ohio, 44109
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Colorado Springs, Colorado, 80910
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Columbia, South Carolina, 29204
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Danbury, Connecticut, 06810
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DeBary, Florida, 32713
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Decatur, Georgia, 30033
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Denver, Colorado, 80209
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Duluth, Georgia, 30096
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Eagle, Idaho, 83616
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Erie, Pennsylvania, 16508
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Escondido, California, 92027
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Evansville, Indiana, 47714
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Flowood, Mississippi, 39232
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Fresno, California, 93720
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Gainesville, Georgia, 30501
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Greenville, South Carolina, 29601
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Hemet, California, 92543
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77090
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Huntsville, Alabama, 35801
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Idaho Falls, Idaho, 83404
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Indianapolis, Indiana, 46227
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Jackson, Mississippi, 39202
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La Jolla, California, 92037
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La Mesa, California, 91942
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Las Vegas, Nevada, 89123
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Lewes, Delaware, 19958
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Little Rock, Arkansas, 72205
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Lubbock, Texas, 79424
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Marietta, Georgia, 30060
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Memphis, Tennessee, 38119
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Mesquite, Texas, 75150
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Myrtle Beach, South Carolina, 29572
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Nassau Bay, Texas, 77058
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North Richland Hills, Texas, 76180
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Omaha, Nebraska, 68134
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Owensboro, Kentucky, 42303
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Palm Harbor, Florida, 34684
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Paradise Valley, Arizona, 85253
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Peoria, Arizona, 85381
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Peoria, Illinois, 61602
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Phoenix, Arizona, 85018
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Phoenixville, Pennsylvania, 19460
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Pinellas Park, Florida, 33781
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Pottstown, Pennsylvania, 19464
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Racine, Wisconsin, 53406
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Sacramento, California, 95825
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San Antonio, Texas, 78215
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Sanford, North Carolina, 27330
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Scottsdale, Arizona, 85251
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Shawnee Mission, Kansas, 66218
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St Louis, Missouri, 63141
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Stockbridge, Georgia, 30281
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Syracuse, New York, 13210
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Tampa, Florida, 33609
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Torrance, California, 90505
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Tulsa, Oklahoma, 74135
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Tustin, California, 92780
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Upland, California, 91786
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Venice, Florida, 34292
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Vero Beach, Florida, 32960
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Waco, Texas, 76708
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Watertown, South Dakota, 57201
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Wildomar, California, 92595
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Worcester, Massachusetts, 01605

Other trials in United States

Japan27 sites

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Aichi, 460-0001
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Chiba, 284-0003
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Fukuoka, 807-8555
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Gunma, 370-0053
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Hokkaido, 060-8604
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Hyōgo, 650-0017
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Ibaraki, 305-8576
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Ibaraki, 316-0035
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Japan, 104-8560
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Kagoshima, 891-0133
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Kanagawa, 252-0392
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Kumamoto, 861-8520
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Mie, 514-1101
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Miyagi, 982-0032
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Miyazaki, 880-0122
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Nagano, 380-8582
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Nagasaki, 857-1195
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Nara, 634-0007
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Ohita, 874-0011
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Okayama, 710-0016
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Osaka, 586-8521
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Saga, 843-0393
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Saitama, 337-0012
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Sapporo, 060-8648
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Tokushima, 770-8503
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Tokyo, 185-0012
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Toyama, 933-0874

Other trials in Japan

Russia13 sites

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Barnaul, 656038
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Kazan', 420029
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Kemerovo, 650066
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Khanty-Mansiysk, 628012
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Moscow, 125299
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Novosibirsk, 630047
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Petrozavodsk, 185019
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Ryazan, 390026
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Saint Petersburg, 194291
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Saratov, 410002
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Stavropol, 355017
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Voronezh, 394066
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Yaroslavl, 150062

Other trials in Russia

India11 sites

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Ahmedabad, 3800015
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Bangalore, 5600092
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Chennai, 600100
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Hyderabaad, 500082
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Jaipur, 302019
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Lucknow, 226 014
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Mysore, 570023
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Nellore, 524003
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New Delhi, 110 076
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Secunderabad, 500 003
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Surat, 395003

Other trials in India

Mexico11 sites

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Aguascalientes, 20203
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Barrio San Mateo, 52140
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Chihuahua City, 31000
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Guadalajara, 44690
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Mexicali, 21100
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Mexico City, 14050
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Monterrey, 64460
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Morelia, 58070
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Querétaro, 76000
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San Luis Potosí City, 78200
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Tijuana, 22010

Other trials in Mexico

Hungary9 sites

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Baja, 6500
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Balassagyarmat, 2660
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Budapest, 1095
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Debrecen, 4012
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Esztergom, 2500
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Kiskunhalas, 6400
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Sátoraljaújhely, 3980
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Szikszó, 3800
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Veszprém, 8200

Other trials in Hungary

Poland9 sites

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Bydgoszcz, 85-168
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Działdowo, 13-200
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Elblag, 82-300
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Gdynia, 81-384
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Lublin, 20-607
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Płock, 09-400
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Torun, 87-100
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Warsaw, 01-192
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Włoszczowa, 29-100

Other trials in Poland

Brazil8 sites

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Campinas, 13059-000
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Caxias do Sul, 95070-560
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Curitiba, 80060-240
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Fortaleza, 60150-170
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Goiânia, 74110-120
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Juiz de Fora, 36010-570
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Rio de Janeiro, 20551-030
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São Paulo, 09090780

Other trials in Brazil

South Africa8 sites

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Benoni, 1500
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Bloemfontein, 9301
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Cape Town, 7925
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Durban, 4001
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Limpopo, 0380
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Pretoria, 0084
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Somerset West, 7130
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Stellenbosch, 7600

Other trials in South Africa

Argentina7 sites

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Buenos Aires, C1280AEB
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Córdoba, X5016KEH
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Luján, 6700
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Mar del Plata, B7600FZN
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Quilmes, B1878DVC
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San Juan, 5400
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San Miguel de Tucumán, 4000

Other trials in Argentina

Bulgaria7 sites

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Burgas, 8000
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Pleven, 5800
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Plovdiv, 4003
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Rousse, 7002
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Sevlievo, 5400
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Sofia, 1784
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Varna, 9000

Other trials in Bulgaria

South Korea7 sites

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Busan, 602-715
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Daegu, 700-721
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Daejeon, 301-721
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Incheon, 400-711
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Seongnam-si, 463-707
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Seoul, 143-729
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Suwon, 442-721

Other trials in South Korea

Ukraine7 sites

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Dnipropetrovsk, 49008
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Donetsk, 83045
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Kharkiv, 61178
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Kyiv, 03151
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Odesa, 65026
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Poltava, 36038
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Vinnytsia, 21018

Other trials in Ukraine

Taiwan6 sites

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Chiayi City, 613
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Keelung, 204
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Kuei Shan Hsiang, 33305
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Niao Sung Hsiang, 833
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Taichung, 404
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Taipei, 112

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Malaysia4 sites

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Kota Bharu, 15586
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Perak, 30990
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Putrajaya, 62250
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Sarawak, 93586

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New Zealand4 sites

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Hamilton, 3204
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Rotorua, 3010
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Tauranga, 3140
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Timaru

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Romania4 sites

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Brasov, 500365
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Cluj-Napoca, 400130
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Iași, 700656
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Ploieşti, 100337

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Sri Lanka4 sites

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Colombo
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Galle
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Kalubowila
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Nugegoda

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Australia3 sites

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Campbelltown, New South Wales, 2560
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Herston, Queensland, 4029
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Malvern East, 3145

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Croatia3 sites

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Opatija, 51410
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Osijek, 31000
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Rijeka, 51 000

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Slovakia3 sites

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Bratislava, 84231
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Dunajská Streda, 929 01
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Piešťany, 921 12

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Colombia2 sites

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Bogotá
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Medellín

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Lithuania2 sites

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Klaipedos, 92288
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Vilnius, LT-08661

Other trials in Lithuania

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate.

This study is comprised of 3 periods:

Period 1: 52-week blinded treatment

Period 2: additional 48-week unblinded treatment

Period 3: 48-week post-treatment follow-up

Conditions: Rheumatoid Arthritis
Being tested: LY2127399, Placebo Q2W, Placebo Q4W, Methotrexate
Keywords: Rheumatoid Arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2127399Drug
Administered Subcutaneously (SC)
Placebo Q2WDrug
Administered SC
Placebo Q4WDrug
Administered SC
MethotrexateDrug
Methotrexate is a background therapy.

Study groups in NCT01198002
Study group	Role	What they receive
120 milligrams (mg) LY2127399	Experimental	Given every 4 weeks (Q4W) for 100 weeks. Participants receive a 240 mg loading dose when initiating treatment. During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Weeks 16 and 52, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. Receives: Drug: LY2127399; Drug: Placebo Q4W; Drug: Methotrexate
90 mg LY2127399	Experimental	Given Q2W for 100 weeks. Participants receive a 180 mg loading dose when initiating treatment. At Weeks 16 and 52, responders will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. Receives: Drug: LY2127399; Drug: Methotrexate
Placebo	Placebo comparator	Given Q2W for 52 weeks. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 52 weeks. At Week 52, responders are randomized to receive 1 of the 2 doses of LY2127399, with loading dose of 240 mg or 180 mg of LY2127399, followed by 120 mg of LY2127399 Q4W or 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. At Week 16, NR will receive a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. Receives: Drug: LY2127399; Drug: Placebo Q2W; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24
ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
Measured: Baseline through 24 weeks
Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 52 Weeks
Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks

Secondary outcomes (27)

Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
ACR Responder Index: Composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had ≥50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No.) of ACR50 responders) / (No. of Pts treated) * 100. ACR70 Responder: had ≥70% improvement from baseline in both TJ and SJ counts and ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response= (No. of ACR70 responders) / (No. of Pts treated) * 100. All NR at Week 16 as well as all Pts who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Weeks 24 and 52 endpoints.
Measured: Baseline through 24 weeks and 52 weeks
Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100.
Measured: Baseline through 24 weeks and 52 weeks
Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores were calculated by summing each item for each domain and transforming scores into a 0-100 scale. Higher scores indicated better health status. If < 50% of the questions within a domain were answered, raw scores were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100. Higher score indicated better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score
The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, Item 1 is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0=no fatigue and 10=fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Change From Baseline in Duration of Morning Stiffness (Minutes)
The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24-hours and pain based on the pain right now with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in past 24-hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score were set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks
Measured: Baseline through 52 weeks
Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) * 100.
Measured: Baseline through 24 weeks
Change From Baseline to Week 52 in B Cell Subset Counts
B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional [CD19+immunoglobulin D (IgD)-CD27-], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 52 weeks
Population Pharmacokinetics (PK): Constant Clearance
Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
Measured: Baseline through 52 weeks
Percentage of Participants Developing Anti-LY2127399 Antibodies
Participants with treatment-emergent anti-drug antibodies (ADA) were participants who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA=(number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.
Measured: Baseline through 52 weeks
Percentage of Participants With No Structural Progression at Week 52
No structural progression is defined as the change in mTSS from baseline ≤0. The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) * 100.
Measured: Baseline through 52 weeks
Change From Baseline to Week 24 in mTSS
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks
Change From Baseline in Serum Immunoglobulin (Ig) Levels
Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
American College of Rheumatology Percent Improvement (ACR-N)
ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJ count, b) % change in SJ count, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.
Measured: Baseline through 24 weeks and 52 weeks
Change From Baseline in Tender Joint Count (68 Joint Count)
Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Change From Baseline in Swollen Joint Count (66 Joint Count)
Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Change From Baseline in Participant's Global Assessment of Disease Activity (VAS)
Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Change From Baseline in Physician's Global Assessment of Disease Activity (VAS)
Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks
Change From Baseline to Week 52 in HAQ-DI
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to Week 52 in Absolute B Cell Counts
Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 52 weeks
Percentage of Participants With ACR20 at Week 52
ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders) /( number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 52 endpoint.
Measured: Baseline through 52 weeks
Time to ACR20 Response
ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks). Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16. Otherwise, they are censored at the date of the Week 16 injection. All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit.
Measured: Baseline through 52 weeks
Change From Baseline in CRP
CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Measured: Baseline, 24 weeks and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Jan 2014

First posted9 Sep 2010 (estimated)
Study startDec 2010
Primary completionDec 2012
Study completionJan 2014

Why it stopped: Terminated not based on safety concerns, but due to insufficient efficacy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,041 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01198002
Sponsor's protocol ID: 11352
Other IDs: H9B-MC-BCDM, CTRI/2011/07/001870
Acronym: FLEX M
Status last verified: May 2018
First submitted: 8 Sep 2010
Last updated: 8 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Smolen JS, Weinblatt ME, van der Heijde D, Rigby WF, van Vollenhoven R, Bingham CO 3rd, Veenhuizen M, Gill A, Zhao F, Komocsar WJ, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study. Ann Rheum Dis. 2015 Aug;74(8):1567-70. doi: 10.1136/annrheumdis-2014-207090. Epub 2015 Apr 14.
PubMed 25873635

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)
ClinicalTrials.gov ID: NCT01198002
Acronym / sponsor ID: FLEX M / 11352
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated not based on safety concerns, but due to insufficient efficacy.
Enrolment: 1,041 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Dec 2012 (actual)
Study completion: Jan 2014 (actual)
First posted: 9 Sep 2010 (estimated)
Results: Posted 8 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate.

This study is comprised of 3 periods:

Period 1: 52-week blinded treatment

Period 2: additional 48-week unblinded treatment

Period 3: 48-week post-treatment follow-up

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
120 milligrams (mg) LY2127399	Experimental	Drug: LY2127399, Drug: Placebo Q4W, Drug: MethotrexateGiven every 4 weeks (Q4W) for 100 weeks. Participants receive a 240 mg loading dose when initiating treatment. During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Weeks 16 and 52, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
90 mg LY2127399	Experimental	Drug: LY2127399, Drug: MethotrexateGiven Q2W for 100 weeks. Participants receive a 180 mg loading dose when initiating treatment. At Weeks 16 and 52, responders will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
Placebo	Placebo comparator	Drug: LY2127399, Drug: Placebo Q2W, Drug: MethotrexateGiven Q2W for 52 weeks. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 52 weeks. At Week 52, responders are randomized to receive 1 of the 2 doses of LY2127399, with loading dose of 240 mg or 180 mg of LY2127399, followed by 120 mg of LY2127399 Q4W or 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. At Week 16, NR will receive a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
At least 8 tender and swollen joints
At least one erosion of a hand or foot joint observed on an X-ray
An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)

Key exclusion criteria (19 listed)

Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks
Steroid injection or intravenous (iv) infusion in the last 6 weeks
Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
History of a serious reaction to other biological DMARDs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2127399Administered Subcutaneously (SC)	Drug	120 milligrams (mg) LY2127399, 90 mg LY2127399, Placebo
Placebo Q2WAdministered SC	Drug	Placebo
Placebo Q4WAdministered SC	Drug	120 milligrams (mg) LY2127399
MethotrexateMethotrexate is a background therapy.	Drug	120 milligrams (mg) LY2127399, 90 mg LY2127399, Placebo

Primary outcome

Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24
Time frame: Baseline through 24 weeks
ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)
Time frame: Baseline, 52 Weeks
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.
Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: Baseline, 24 weeks
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

27 secondary outcomes

Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
Time frame: Baseline through 24 weeks and 52 weeks
Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
Time frame: Baseline, 24 weeks and 52 weeks
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
Time frame: Baseline through 24 weeks and 52 weeks
Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
Time frame: Baseline, 24 weeks and 52 weeks
Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score
Time frame: Baseline, 24 weeks and 52 weeks
Change From Baseline in Duration of Morning Stiffness (Minutes)
Time frame: Baseline, 24 weeks and 52 weeks
Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Time frame: Baseline, 24 weeks and 52 weeks
Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks
Time frame: Baseline through 52 weeks
Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0
Time frame: Baseline through 24 weeks
Change From Baseline to Week 52 in B Cell Subset Counts
Time frame: Baseline, 52 weeks
Population Pharmacokinetics (PK): Constant Clearance
Time frame: Baseline through 52 weeks
Percentage of Participants Developing Anti-LY2127399 Antibodies
Time frame: Baseline through 52 weeks
Percentage of Participants With No Structural Progression at Week 52
Time frame: Baseline through 52 weeks
Change From Baseline to Week 24 in mTSS
Time frame: Baseline, 24 weeks
Change From Baseline in Serum Immunoglobulin (Ig) Levels
Time frame: Baseline, 52 weeks
Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)
Time frame: Baseline, 24 weeks and 52 weeks
American College of Rheumatology Percent Improvement (ACR-N)
Time frame: Baseline through 24 weeks and 52 weeks
Change From Baseline in Tender Joint Count (68 Joint Count)
Time frame: Baseline, 24 weeks and 52 weeks
Change From Baseline in Swollen Joint Count (66 Joint Count)
Time frame: Baseline, 24 weeks and 52 weeks
Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Time frame: Baseline, 24 weeks and 52 weeks
Change From Baseline in Participant's Global Assessment of Disease Activity (VAS)
Time frame: Baseline, 24 weeks and 52 weeks
Change From Baseline in Physician's Global Assessment of Disease Activity (VAS)
Time frame: Baseline, 24 weeks and 52 weeks
Change From Baseline to Week 52 in HAQ-DI
Time frame: Baseline, 52 weeks
Change From Baseline to Week 52 in Absolute B Cell Counts
Time frame: Baseline, 52 weeks
Percentage of Participants With ACR20 at Week 52
Time frame: Baseline through 52 weeks
Time to ACR20 Response
Time frame: Baseline through 52 weeks
Change From Baseline in CRP
Time frame: Baseline, 24 weeks and 52 weeks

Results and safety

Results posted to the registry on 8 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
120 mg LY2127399	345	70
90 mg LY2127399	347	73
Placebo	349	80

Primary outcome: Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24

Time frame: Baseline through 24 weeks. Number. Unit: percentage of participants

Measure	120 mg LY2127399 n = 330	90 mg LY2127399 n = 332	Placebo n = 335
Value	29.7	32.8	25.1

Population analysed: All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.

Primary outcome: Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)

Time frame: Baseline, 52 Weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	120 mg LY2127399 n = 295	90 mg LY2127399 n = 304	Placebo n = 306
Value	1.43 (0.27)	0.84 (0.27)	1.57 (0.27)

Population analysed: All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.

Primary outcome: Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)

Time frame: Baseline, 24 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	120 mg LY2127399 n = 329	90 mg LY2127399 n = 327	Placebo n = 328
Value	-0.26 (0.03)	-0.30 (0.03)	-0.20 (0.03)

Population analysed: All randomized participants with evaluable HAQ-DI data. Modified Baseline Observation Carried Forward (mBOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.

27 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY 120 mg Q4W, Randomized Treatment Period 1	19 of 345 (5.5%)	137 of 345 (39.7%)	Not reported
LY 90 mg Q2W, Randomized Treatment Period 1	17 of 345 (4.9%)	117 of 345 (33.9%)	Not reported
Placebo, Randomized Treatment Period 1	17 of 348 (4.9%)	129 of 348 (37.1%)	Not reported
LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Rescue Period	3 of 58 (5.2%)	22 of 58 (37.9%)	Not reported
LY 90 mg Q2W, Rescue Period	3 of 62 (4.8%)	25 of 62 (40.3%)	Not reported
Placebo to LY 90 mg Q2W (Week 16), Rescue Period	2 of 90 (2.2%)	20 of 90 (22.2%)	Not reported
LY 120 mg Q4W, Treatment Period 2	1 of 57 (1.8%)	22 of 57 (38.6%)	Not reported
LY 90 mg Q2W, Treatment Period 2	1 of 73 (1.4%)	20 of 73 (27.4%)	Not reported
Placebo to LY 120 mg Q4W (Week 52), Treatment Period 2	2 of 27 (7.4%)	7 of 27 (25.9%)	Not reported
Placebo to LY 90 mg Q2W (Week 52), Treatment Period 2	1 of 31 (3.2%)	4 of 31 (12.9%)	Not reported
LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Treatment Period 2	0 of 13 (0%)	7 of 13 (53.8%)	Not reported
Placebo to LY 90 mg Q2W (Week 16), Treatment Period 2	0 of 22 (0%)	9 of 22 (40.9%)	Not reported
LY 120 mg Q4W, Follow-up Period	9 of 241 (3.7%)	43 of 241 (17.8%)	Not reported
LY 90 mg Q2W, Follow-up Period	14 of 303 (4.6%)	39 of 303 (12.9%)	Not reported
Placebo to LY 120 mg Q4W (Week 52), Follow-up Period	1 of 27 (3.7%)	6 of 27 (22.2%)	Not reported
Placebo to LY 90 mg Q2W (Week 52), Follow-up Period	1 of 27 (3.7%)	9 of 27 (33.3%)	Not reported
LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period

Limitations and caveats (from the sponsor): This study has been terminated not based on safety concerns, but due to insufficient efficacy. Early termination led to lower than expected enrollment and was responsible for the large number of discontinuation reason as Sponsor Decision.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25873635Smolen JS, Weinblatt ME, van der Heijde D, Rigby WF, van Vollenhoven R, Bingham CO 3rd, Veenhuizen M, Gill A, Zhao F, Komocsar WJ, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study. Ann Rheum Dis. 2015 Aug;74(8):1567-70. doi: 10.1136/annrheumdis-2014-207090. Epub 2015 Apr 14.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

234 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY2127399 and Methotrexate in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 234 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 234 sites in United States, Japan, Russia, India, Mexico and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24 (time frame: Baseline through 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01198002, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.