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Rheumatoid ArthritisPhase 3NCT01855789

A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX

A Phase 3 study testing Tocilizumab (TCZ) and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 155 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. 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?
Tocilizumab (TCZ) and Methotrexate (MTX)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
718 participants
Where
155 sitesUnited States
Study dates
7 Nov 2013to 14 Oct 2016
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

  • Body weight </=150 kg
  • Active moderate to severe rheumatoid arthritis (DAS28 >/=4.4) according to the revised 1987 ACR criteria at screening and baseline (prior to treatment on Day 1)
  • Currently receiving oral MTX for at least 24 weeks and on a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1), with the following exception: a stable dose of at least 10 mg/week is allowed for participants with a body weight <50 kg or calculated glomerular filtration rate (or creatinine clearance) <60 milliliters per minute (mL/min)
  • History of parenteral (SC or intramuscular [IM]) MTX is allowed, but not within 6 weeks prior to treatment (Day 1). Participants must not have a documented, clinically significant intolerance to oral MTX and must be receiving oral MTX at a dose of 15 mg/week for at least 6 weeks prior to treatment (Day 1)
  • Participants who have received one prior anti-tumor necrosis factor (TNF) must have discontinued etanercept, infliximab, certolizumab, adalimumab, or golimumab for at least 6 months prior to screening
  • Oral corticosteroids must have been </=10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to treatment (Day 1)
  • Participants receiving treatment on an outpatient basis

Who cannot join

  • Documented medical history of significant intolerance to oral MTX >/=15 mg/week
  • Participants receiving other (non-MTX) disease modifying anti-rheumatic drugs (DMARDs) within 8 weeks of screening
  • Previous treatment with abatacept, rituximab, tofacitinib, or anakinra
  • Treatment with parenteral corticosteroids within 4 weeks prior to treatment
  • Previous treatment with cell-depleting therapies or alkylating agents
  • Previous treatment with TCZ
Show all 19Show fewer
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • Non-rheumatic active autoimmune diseases (for example, inflammatory bowel diseases, psoriasis, multiple sclerosis)
  • Prior history of or current inflammatory joint disease other than rheumatoid arthritis
  • Functional Class IV according to the revised (1987) ACR criteria for rheumatoid arthritis
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Evidence of significant uncontrolled concomitant diseases; uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids
  • Active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
  • Active tuberculosis requiring treatment within the previous 3 years
  • History of or currently active primary or secondary immunodeficiency
  • Pregnant or breast-feeding women
  • Positive for hepatitis B or hepatitis C infection
  • For potential MRI substudy participants: the presence of any metal-containing device or object in the body

Trial locations and contacts

155 sites in 1 country.

155 sites in 1 country

United States155 sites

  • Crystal Arthritis Center, Inc.

    Akron, Ohio, 44333

  • The Center for Rheumatology

    Albany, New York, 12203

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124

  • Pinnacle Research Group; Llc, Central

    Anniston, Alabama, 36207

  • Arthritis Care Center Oklahoma

    Ardmore, Oklahoma, 73401

  • Asheville Arthritis & Osteoporosis Center, PA

    Asheville, North Carolina, 28803

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Austin Regional Clinic

    Austin, Texas, 78731

  • Lovelace Scientific Resources Inc.

    Austin, Texas, 78758

  • Arthritis & Rheumatism; Disease Specialities

    Aventura, Florida, 33180

  • Diagnostic Group

    Beaumont, Texas, 77701

  • Uni Of Alabama,Birmingham; Medicine - Rheumatology

    Birmingham, Alabama, 35294

  • St. Alexius Medical Center; Arthritis Clinic

    Bismarck, North Dakota, 58501

  • Odyssey Research Services; Main Medical Building

    Bismarck, North Dakota, 58507

  • New England Medical Center; Dept. of Medicine, Div. of Rheumatology

    Boston, Massachusetts, 02111

  • Joao Nascimento

    Bridgeport, Connecticut, 06606

  • Arthritis & Osteoporosis Center

    Brooklyn, New York, 11201

  • Low Country Rheumatology, PA

    Charleston, South Carolina, 29406

  • Carolina Bone & Joint P.A.

    Charlotte, North Carolina, 28210

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio, 45219

  • Mountain State Clinical Research

    Clarksburg, West Virginia, 26301

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44109

  • AOCBV

    College Station, Texas, 77845

  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

    Colorado Springs, Colorado, 80920

  • Columbia Arthritis Center (Partnership Practice)

    Columbia, South Carolina, 29204

  • Ohio State University; Rheumatology; Immun/Rheum

    Columbus, Ohio, 43203

  • Columbus Arthritis Center

    Columbus, Ohio, 43215

  • Adriana Pop-Moody MD Clinic PA

    Corpus Christi, Texas, 78404

  • Medvin Clinical Research

    Covina, California, 91723

  • Arthritis Care & Diagnostic Center

    Dallas, Texas, 75231-4406

  • Metroplex Clinical Research

    Dallas, Texas, 75231

  • Clinical Research Center of Ct/Ny

    Danbury, Connecticut, 06810

  • STAT Research Inc

    Dayton, Ohio, 45417

  • Denver Arthritis Clinic

    Denver, Colorado, 80230-7127

  • North Georgia Rheumatology

    Duluth, Georgia, 30096

  • St. Luke's Hospital Association of Duluth

    Duluth, Minnesota, 55805

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Robert Levin, Md; Research Dept

    Dunedin, Florida, 34698

  • Triangle Orthopaedics Associates, P.A.

    Durham, North Carolina, 27704

  • St. Paul Rheumatology

    Eagan, Minnesota, 55121

  • TriWest Research Associates, LLC

    El Cajon, California, 92020

  • Arthritis Associates

    Erie, Pennsylvania, 16508

  • Phase Iii Clinical Research

    Fall River, Massachusetts, 02720

  • David S Rosenberg

    Florissant, Missouri, 63031

  • Arthritis and Osteoporosis; Treatment and Research Center

    Flowood, Mississippi, 39232

  • Jackson Arthritis Clinic

    Flowood, Mississippi, 39232

  • Fort Smith Rheumatology, PC

    Fort Smith, Arkansas, 72903

  • St. Jude Hospital Yorba Linda DBA St. Joseph

    Fullerton, California, 92835

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Glendale, Arizona, 85306

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Medication Management

    Greensboro, North Carolina, 27408

  • Piedmont Arthritis Clinic

    Greenville, South Carolina, 29601

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland, 21740

  • Arthritis & Osteoporosis Center Pc

    Hamden, Connecticut, 06518

  • CV Mehta MD Medical Corp

    Hemet, California, 92543

  • PMG Research of Hickory LLC

    Hickory, North Carolina, 28602

  • CHI St. Vincent Medical Group Hot Springs

    Hot Springs, Arkansas, 71913

  • Rheumatic Disease Clin Res Ctr

    Houston, Texas, 77004

  • IntraFusion Researh Network

    Houston, Texas, 77007

  • Houston Inst. For Clinical Research

    Houston, Texas, 77074

  • Accurate Clinical Research

    Houston, Texas, 77089

  • Rheumatology Associates of North Alabama

    Huntsville, Alabama, 35801

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • Indiana Uni Medical Center

    Indianapolis, Indiana, 46202

  • Diagnostic Rheumatology & Research

    Indianapolis, Indiana, 46227

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Clinical Research Consultants,LLC

    Kansas City, Missouri, 64111

  • Advanced Rheumatology, PC

    Lansing, Michigan, 48910

  • Fiechtner Research Inc

    Lansing, Michigan, 48910

  • Arthritis and Osteoporosis Associates of New Mexico

    Las Cruces, New Mexico, 88011

  • G. T. Kelly, MD

    Las Vegas, Nevada, 89128

  • North Georgia Rheumatology Group, PC

    Lawrenceville, Georgia, 30046

  • Rheumatology Research Group

    Lebanon, New Hampshire, 03756

  • Cape Fear Arthritis Care

    Leland, North Carolina, 28451

  • Rheumatolgy Consultants of Deleware

    Lewes, Delaware, 19958

  • Bluegrass Comm Research, Inc.

    Lexington, Kentucky, 40515

  • Little Rock Diagnostic Clinic

    Little Rock, Arkansas, 72205

  • Valerius Medical Group

    Los Alamitos, California, 90720

  • Arthritis and Osteoporosis Associates

    Manalapan, New Jersey, 07726

  • Manhasset Rheumatology

    Manhasset, New York, 11030

  • Lakeshore Orthopedics

    Manitowoc, Wisconsin, 54220

  • Mansfield Medical Center

    Mansfield, Massachusetts, 02048

  • Ramesh Gupta - PP

    Memphis, Tennessee, 38119

  • Arizona Arthritis & Rheumatology Research, Pllc

    Mesa, Arizona, 85202

  • Arizona Arthritis and Rheuma

    Mesa, Arizona, 85202

  • Southwest Rheumatology

    Mesquite, Texas, 75150

  • Suncoast Research Group LLC

    Miami, Florida, 33135

  • South Coast Research Center, Inc.

    Miami, Florida, 33136

  • Precision Research Organization

    Miami Lakes, Florida, 33016

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Arthritis & Diabetes Clinic, Inc

    Monroe, Louisiana, 71203

  • Jeffrey Alper M.D Research

    Naples, Florida, 34102

  • Nashua Rheumatology - Foundation Medical Partners

    Nashua, New Hampshire, 03060

  • Manhattan Medical Reserach

    New York, New York, 10016

  • Javed Rheumatology Associates, Inc.

    Newark, Delaware, 19713

  • Arthritis and Rheumatology; Center of Oklahoma PLLC

    Oklahoma City, Oklahoma, 73103

  • Health Research of Oklahoma, Llc

    Oklahoma City, Oklahoma, 73103

  • Lynn Health Science Inst.

    Oklahoma City, Oklahoma, 73112

  • South Puget Sound Clinical Research

    Olympia, Washington, 98502

  • Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med

    Onalaska, Wisconsin, 54605

  • NRC Research Institute

    Orange, California, 92868

  • Buffalo Rheumatology Associates

    Orchard Park, New York, 14127

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806

  • Arthritis and Rheumatology Clinic

    Orlando, Florida, 32836

  • Kansas City Internal Medicine

    Overland Park, Kansas, 66209

  • Arthritis Center Palm Harbor

    Palm Harbor, Florida, 34684

  • Arthritis Rsrch of Florida, Inc.

    Palm Harbor, Florida, 34684

  • Nisus Research/Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Valley Arthritis Care

    Phoenix, Arizona, 85027

  • Office of Premier Chatpar Md

    Plainview, New York, 11803

  • Shanahan Rheumatology & Immunology, PLLC

    Raleigh, North Carolina, 27617

  • Shores Rheumatology

    Saint Clair Shores, Michigan, 48081

  • Accurate Clinical Management

    San Antonio, Texas, 78229

  • NextGen Clinical Research Inc

    San Antonio, Texas, 78229

  • Arthiritis & Osteoporosis Centre of South Texas

    San Antonio, Texas, 78232

  • San Diego Arthritis Med Clnc

    San Diego, California, 92108

  • C Michael Neuwelt MD Inc

    San Leandro, California, 94578

  • Arthritis Clinic Of Central Texas

    San Marcos, Texas, 78666

  • Sarasota Arthritis Res Center

    Sarasota, Florida, 34239

  • Advanced Arthritis Care & Research

    Scottsdale, Arizona, 85258

  • Rheumatology Associates of Long Island

    Smithtown, New York, 11787

  • Arthritis Northwest, Spokane

    Spokane, Washington, 99204

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Clayton Medical Research

    St Louis, Missouri, 63117

  • Arthritis Consultants

    St Louis, Missouri, 63141

  • Pinellas Medical Research - Allegry & Rheumatology Associates, LLC

    St. Petersburg, Florida, 33708

  • Arthritis Health Associates

    Syracuse, New York, 13210

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida, 33321

  • McIlwain Medical Group

    Tampa, Florida, 33613

  • Burnette & Silverfield, MDS

    Tampa, Florida, 33614

  • Clinical Research Source, Inc.

    Toledo, Ohio, 43606

  • Atlantic Coast Rheumatology

    Toms River, New Jersey, 08755

  • Ocean Rheumatology

    Toms River, New Jersey, 08775

  • New England Research Associates

    Trumbull, Connecticut, 06611

  • Oklahoma Center For Arthritis Therapy & Research

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

  • Clnical & Translational Reseach Center for Alabama, PC

    Tuscaloosa, Alabama, 35406

  • Inland Rheumatology; Clinical Trials, Inc.

    Upland, California, 91785-1141

  • Crossroads Clinical Research, LLC

    Victoria, Texas, 77901

  • Arthritis Rheumatic & Back Disease Associates

    Voorhees Township, New Jersey, 08043

  • Cooper Cancer Institute

    Voorhees Township, New Jersey, 08043

  • Arthritis & Osteoporosis Clinic

    Waco, Texas, 76710

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • Advanced Rheumatology & Arthritis Research Center

    Wexford, Pennsylvania, 15090

  • Medvin Clinical Research

    Whittier, California, 90606

  • Advanced Clinical Research of Orlando, Inc.

    Winter Garden, Florida, 34787

  • Reliant Medical Group, Inc; Rheumatology

    Worcester, Massachusetts, 01605

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania, 19610

  • Emkey Arthritis & Osteoporosis

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: A Randomized, Double-Blind Trial Assessing the Impact of Methotrexate Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate Therapy

This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose orally in an open-label manner for 24 weeks. Participants with a disease activity score based on 28 joints (DAS28) less than or equal to (</=) 3.2 at Week 24, will be randomized to either continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52. Participants without a DAS28 score </=3.2 at Week 24, will continue the same treatment in a non-randomized open-label manner up to Week 52.

Being tested
Tocilizumab (TCZ), Methotrexate (MTX), Placebo (PBO)
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Tocilizumab (TCZ)Drug

    Also called Actemra

    TCZ will be administered at a dose of 162 milligrams (mg) via SC injection weekly (if body weight is greater than or equal to [>/=] 100 kilograms [kg]) or every 2 weeks (if body weight was less than [<] 100 kg).

  • Methotrexate (MTX)Drug

    MTX will be administered at a stable dose (15 mg to 25 mg per week) orally.

  • Placebo (PBO)Drug

    PBO matching to MTX will be administered orally.

Study groups in NCT01855789
Study groupRoleWhat they receive
Non-Randomized Participants (TCZ + MTX)ExperimentalAll participants will receive initial treatment with open-label TCZ + MTX. Participants who complete 24-week treatment with open-label TCZ + MTX and did not achieve a DAS28 score </=3.2 at Week 24, will continue receiving TCZ + MTX in open label manner up to Week 52.
Receives: Drug: Tocilizumab (TCZ); Drug: Methotrexate (MTX)
Randomized Participants (TCZ + MTX)ExperimentalParticipants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score </=3.2 at Week 24, will be randomized to receive TCZ along with MTX up to Week 52.
Receives: Drug: Tocilizumab (TCZ); Drug: Methotrexate (MTX)
Randomized Participants (TCZ + PBO)Active comparatorParticipants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score </=3.2 at Week 24, will be randomized to receive TCZ along with MTX matched placebo (PBO) up to Week 52.
Receives: Drug: Tocilizumab (TCZ); Drug: Placebo (PBO)

What is being measured

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

  1. Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40

    The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.

    Measured: Week 24, Week 40

Secondary outcomes (10)

  1. Percentage of Participants Achieving 20% Improvement in American College of Rheumatology (ACR20) Response

    The ACR20 response at any time was defined as >/=20% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via a Health Assessment Questionnaire-Disability Index (HAQ-DI), and 5) Acute phase reactant (ESR in mm/h or C-Reactive Protein [CRP] in milligrams per deciliter [mg/dL]).

    Measured: Weeks 24, 40, and 52

  2. Percentage of Participants Achieving 50% Improvement in American College of Rheumatology (ACR50) Response

    The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).

    Measured: Weeks 24, 40, and 52

  3. Percentage of Participants Achieving 70% Improvement in American College of Rheumatology (ACR70) Response

    The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).

    Measured: Weeks 24, 40, and 52

  4. Percentage of Participants With >/=1.2 Points Increase (Worsening) From Week 24 in DAS28 Score at Week 40 and 52

    The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28- score could range from 0 to 10, where higher score represented higher disease activity.

    Measured: Week 24, 40, and 52

  5. Percentage of Participants With DAS28 Score <2.6 (DAS28 Remission)

    The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity.

    Measured: Week 40, Week 52

  6. Percentage of Participants With DAS28 Score </=3.2 (Low DAS28)

    The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28-ESR score could range from 0 to 10, where higher score represented higher disease activity.

    Measured: Week 40, Week 52

  7. Change From Week 24 in Bone Erosion Score at Week 40 for Participants in the Magnetic Resonance Imaging (MRI) Substudy

    Bones from the wrist regions (carpal bones, distal radius, distal ulna, and metacarpal bases) and the metacarpophalangeal (MCP) joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranged from 0 (no erosion) to 10 (91-100%). Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value for change from Week 24 in bone erosion score indicated an improvement.

    Measured: Weeks 24, Week 40

  8. Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TCZ

    Percentage of participants with positive results for ATA against TCZ at Baseline and at any of the post-baseline assessment time-points was reported. Participants positive at any post-baseline time points were participants who had no positivity at baseline for the same assay.

    Measured: Baseline, Post-baseline (assessed at Weeks 12, 24, 36, 52 and at follow up [Week 60])

  9. Mean TCZ Serum Concentration

    Measured: Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)

  10. Mean Soluble Interleukin-6 (IL-6) Receptor Concentration

    Measured: Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)

Timeline

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

  1. First posted17 May 2013 (estimated)
  2. Study start7 Nov 2013
  3. Primary completion14 Oct 2016
  4. Study completion14 Oct 2016

Resources

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
718 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01855789
Sponsor's protocol ID
ML28776
Status last verified
Nov 2017
First submitted
14 May 2013
Last updated
26 Dec 2017

Publications

  • Kremer JM, Rigby W, Singer NG, Birchwood C, Gill D, Reiss W, Pei J, Michalska M. Sustained Response Following Discontinuation of Methotrexate in Patients With Rheumatoid Arthritis Treated With Subcutaneous Tocilizumab: Results From a Randomized, Controlled Trial. Arthritis Rheumatol. 2018 Aug;70(8):1200-1208. doi: 10.1002/art.40493. Epub 2018 Jun 14.

    PubMed 29575803

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tocilizumab (TCZ) and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 155 sites in United States.

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: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States. 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. 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 26 Dec 2017). 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?

Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40 (time frame: Week 24, Week 40). 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 NCT01855789, 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 26 Dec 2017.

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