AzTrials
AzTrials

Rheumatoid ArthritisPhase 3CREDO 3NCT02760433

Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease

A Phase 3 study testing Olokizumab in people with Rheumatoid Arthritis, run by R-Pharm International, LLC at 116 sites in 11 countries.

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

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with an existing medication called a tumour necrosis factor alpha inhibitor The primary objective of this… 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?
Olokizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
368 participants
Where
116 sitesin 11 countries
Study dates
25 Jan 2017to 1 Oct 2019
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

  • Subjects may be enrolled in the study only if they meet all of the following criteria.
  • Subjects willing and able to sign informed consent
  • Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 24 weeks prior to Screening.
  • (If the subject was diagnosed according to ACR 1987 criteria previously, the Investigator may classify the subject per ACR 2010 retrospectively, using available source data.)
  • Treatment with oral, SC, or intramuscular (IM) MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses)
  • The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening.
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  • Subjects must be willing to take folic acid or equivalent throughout the study.
  • Subjects must have moderately to severely active RA disease as defined by all of the following:
  • ≥6 tender joints (68 joint count) at Screening and baseline; and
  • ≥6 swollen joints (66 joint count) at Screening and baseline; and
  • C-reactive protein (CRP) above Upper limit of normal (ULN) at Screening based on the central laboratory results.
  • Subjects must have a documented inadequate response to treatment (i.e., TNFi failure) with ≥1 licensed TNFi following at least 12 weeks of therapy with that agent. Inadequate response to treatment is classified as either:
  • Primary failure: The absence of any documented clinically significant response; or
  • Secondary failure: Documented initial response with subsequent loss of that response or partial response

Who cannot join

  • Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus) (However, subjects may have secondary Sjogren's syndrome or hypothyroidism.)
  • Subjects who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)
  • Prior exposure to any licensed or investigational compound directly or indirectly targeting Interleukin (IL) 6 or IL 6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase [SYK] inhibitors)
  • Prior treatment with cell depleting therapies including anti CD20 or investigational agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19) with the exception of rituximab, which is allowed if it was discontinued at least 24 weeks prior to baseline (rituximab should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA).
  • Prior use of bDMARDs, within the following windows prior to baseline (bDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):
  • 4 weeks for etanercept and anakinra
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  • 8 weeks for infliximab
  • 10 weeks for adalimumab, certolizumab, and golimumab
  • 12 weeks for abatacept
  • Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline
  • Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline
  • Prior documented history of no response to hydroxychloroquine and sulfasalazine
  • Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):
  • 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline
  • 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours
  • 24 weeks for cyclophosphamide
  • Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study
  • Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline
  • Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline
  • Use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline
  • Use of non steroidal anti inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline
  • Previous participation in this study (randomized) or another study of OKZ
  • Subjects with concurrent acute or chronic viral Hepatitis B or C infection as detected by blood tests at Screening (e.g., positive for hepatitis B surface antigen [HBsAg], total hepatitis B core antibody [anti-HBc], or hepatitis C virus antibody [HCV Ab])
  • subjects who are positive for hepatitis B surface antibodies (anti-HBs), but negative for HBsAg and anti-HBc, will be eligible.
  • Subjects with HIV infection
  • Subjects with:
  • Suspected or confirmed current active tuberculosis (TB) disease or a history of active TB disease.
  • Close contact (i.e., sharing the same household or other enclosed environment, such as a social gathering place, workplace, or facility, for extended periods during the day) with an individual with active TB within 1.5 years prior to Screening
  • Concurrent malignancy or a history of malignancy within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to Screening [and no more than 3 excised skin cancers within the last 5 years prior to Screening])
  • Subjects with any infection requiring oral antibiotic or antiviral therapy in the 2 weeks prior to Screening or at baseline, injectable anti-infective therapy in the last 4 weeks prior to baseline, or serious or recurrent infection with history of hospitalization in the 6 months prior to baseline
  • Subjects with evidence of disseminated herpes zoster infection, zoster encephalitis, meningitis, or other non-self-limited herpes zoster infections in the 6 months prior to baseline
  • Subjects with planned surgery during the study or surgery ≤ 4 weeks prior to Screening and from which the subject has not fully recovered, as judged by the Investigator
  • Subjects with diverticulitis or other symptomatic GI conditions that might predispose the subject to perforations, including subjects with history of such predisposing conditions (e.g., diverticulitis, GI perforation, or ulcerative colitis)
  • Pre-existing central nervous system demyelinating disorders (e.g., multiple sclerosis and optic neuritis)
  • History of chronic alcohol or drug abuse as judged by the Investigator
  • Subjects with a known hypersensitivity to any component of the OKZ drug product or placebo
  • Subjects with a known hypersensitivity or contraindication to any component of the rescue medication
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Female subjects who are pregnant, currently lactating, have lactated within the last 12 weeks, or who are planning to become pregnant during the study or within 6 months of the last dose of study treatment
  • Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status [e.g., correlative age] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment
  • OR
  • Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

116 sites in 11 countries.

116 sites in 11 countries

United States50 sites

  • Lovelace Scientific Resources, Inc.

    Albuquerque, New Mexico, 87114

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Austin Regional Clinic, P.A.

    Austin, Texas, 78731

  • Accurate Clinical Research, Inc.

    Baytown, Texas, 77521

  • RASF - Clinical Research Center

    Boca Raton, Florida, 33486

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Low Country Research Center

    Charleston, South Carolina, 29486

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio, 45242

  • Medvin Clinical Research

    Covina, California, 91722

  • STAT Research, Inc.

    Dayton, Ohio, 45417

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • TriWest Research Associates, LLC

    El Cajon, California, 92020-4124

  • Arthritis & Osteoporosis Associates, PA

    Freehold, New Jersey, 07728

  • Saint Jude Heritage Medical Grp

    Fullerton, California, 92835

  • Precision Comprehensive Clinical Research Solutions

    Grapevine, Texas, 76034

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • Klein and Associates, M.D., P.A.

    Hagerstown, Maryland, 21740

  • С V Mehta MD Med Corp.

    Hemet, California, 92543

  • CHI St. Vincent Hot Springs

    Hot Springs, Arkansas, 71913

  • Therapeutic Concepts Rheumatology, LLC

    Houston, Texas, 77004

  • Rheumatology Clinic of Houston, P.A.

    Houston, Texas, 77065

  • Accurate Clinical Research, Inc.

    Houston, Texas, 77089

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77429

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • Glacier View Research Instutute-Rheumatology

    Kalispell, Montana, 59901

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Advanced Medical Research, LLC

    Lakewood, California, 90623

  • Accurate Clinical Research, Inc.

    League City, Texas, 77573

  • Cape Fear Arthritis Care

    Leland, North Carolina, 28451

  • Endocrinology, Internal Medicine

    Lubbock, Texas, 79410

  • Suncoast Research Group LLC

    Miami, Florida, 33135

  • Trinity Medical Group

    Minot, North Dakota, 58701

  • The Arthritis & Diabetes Clinic, Inc.

    Monroe, Louisiana, 71203

  • NYU Langone Ambulatory Care

    New York, New York, 11201

  • Javed Rheumatology Associates

    Newark, Delaware, 19713

  • Omega Research Consultants

    Orlando, Florida, 32810

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • Family Clinical Trials, LLC.

    Pembroke Pines, Florida, 33026

  • Clinical Research Source, Inc.

    Perrysburg, Ohio, 43606

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona, 85032

  • Riverside Medical Clinic

    Riverside, California, 92506

  • Dr. Alex De Jesus Rheumatology, P.A.

    San Antonio, Texas, 78229

  • East Bay Rheumatology Medical Group, Inc.

    San Leandro, California, 94578

  • AdventHealth Medical Group, PA

    Tampa, Florida, 33614

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401

  • Advanced Rheumatology of Houston

    Woodville, Texas, 77382

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

Other trials in United States

Argentina13 sites

  • Atencion Integral en Reumatologia (AIR)

    Ciudad Autonoma Buenos Aires, 1426

  • Organizacion Medica de Investigacion (OMI)

    Ciudad Autonoma Buenos Aires, C1015ABO

  • APRILLUS

    Ciudad Autonoma Buenos Aires, C1046AAQ

  • Instituto Centenario

    Ciudad Autonoma Buenos Aires, C1204AAD

  • Hospital Privado Centro Medico de Cordoba S.A

    Córdoba, 5016

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FYK

  • Instituto de Investigaciones Clinicas

    Mar del Plata, Buenos Aires, B7600FZN

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

  • Clinica de Higado y Aparato Digestivo

    Rosario, Santa Fe Province, S2000CFJ

  • Centro Polivalente de Asistencia e Inv. Clinica CER

    San Juan, 5400

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Centro de Investigaciones Reumatológicas

    San Miguel de Tucumán, Tucumán Province, T4000BRD

  • Sanatorio San Martin

    Venado Tuerto, Santa Fe Province, S2600KUE

Other trials in Argentina

Brazil12 sites

  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.

    Curitiba, Paraná, 80030-110

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza, Ceará, 60430-370

  • CIP - Centro Internacional de Pesquisa

    Goiânia, Goiás, 74110-120

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-010

  • LMK Serviços Médicos S/S Ltda

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Clínica de Neoplasias Litoral Ltda.

    Santa Catarina, 88301-215

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Centro Multidisciplinar de Estudos Clínicos - CEMEC

    São Bernardo do Campo, São Paulo, 09715-090

  • CPCLIN - Centro de Pesquisas Clínicas Ltda.

    São Paulo, 01228-200

  • Associação de Assistência à Criança Deficiente - AACD

    São Paulo, 04032-060

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055450

Other trials in Brazil

Mexico8 sites

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000

  • Clinica de Investigacion en Reumatologia y Obesidad S.C.

    Guadalajara, Jalisco, 44650

  • Centro de Estudios de Investigacion Basica y Clinica SC

    Guadalajara, Jalisco, 44690

  • Centro de Investigacion Clínica GRAMEL S.C

    Mexico City, Mexico City, 03720

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 06700

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

    San Luis Potosí City, San Luis Potos, 78213

Other trials in Mexico

Russia8 sites

  • State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department

    Moscow, Moscow Oblast, 111539

  • FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"

    Moscow, 115522

  • City Clinical Hospital #1

    Novosibirsk, Novosibirsk Oblast, 630099

  • Diagnostic Center Ultramed

    Omsk, Omsk Oblast, 644024

  • SBHI of the Republic of Karelia "Republican Hospital named after V.A.Baranov"

    Petrozavodsk, Republic of Karelia, 185019

  • Rostov State Medical Unversity

    Rostov-on-Don, Rostov Oblast, 344022

  • SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"

    Stavropol, Stavropol Kray, 355030

  • Regional Clinical Hospital

    Vladimir, Vladimirskaya Oblast’, 600023

Other trials in Russia

Poland6 sites

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 85-168

  • McBk S.C.

    Grodzisk Mazowiecki, 05-825

  • Centrum Medyczne AMED

    Lodz, 91-363

  • Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego

    Sieradz, 98-200

  • Samodzielny Publiczny ZOZ Tomaszow Lubelski

    Tomaszów Lubelski, 22-600

  • McM Polimedica

    Warsaw, 02-777

Other trials in Poland

Colombia4 sites

  • Centro de Reumatologia y Ortopedia SAS

    Barranquilla, 80020

  • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM

    Bogotá, 110221

  • Medicity S.A.S.

    Bucaramanga, 680003

  • Clinica de Artritis Temprana S.A.

    Cali, 76001

Other trials in Colombia

Czechia4 sites

  • Revmatologie MUDr. Klara Sirova s.r.o.

    Ostrava - Moravska Ostrava, 70200

  • CCR Czech, a.s.

    Pardubice, 53002

  • MEDICAL PLUS s.r.o.

    Uherské Hradiště, 68601

  • PV - Medical, s.r.o.

    Zlín, 760 01

Other trials in Czechia

Hungary4 sites

  • Clinexpert Egeszsegugyi Szolg. es Ker. Kft.

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum

    Budapest, 1036

  • MAV Korhaz és Rendelointezet

    Szolnok, 5000

  • Vital Medical Center

    Veszprém, 8200

Other trials in Hungary

South Korea4 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Hallym University Sacred Heart Hospital

    Gyeonggi-do, 431-796

  • Severance Hospital, Yonsei University

    Seoul, 3722

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 443-380

Other trials in South Korea

Germany3 sites

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, Hesse, 61231

  • HRF Hamburger Rheuma Forschungszentrum

    Hamburg, 20095

  • SMO.MD GmbH

    Magdeburg, Saxony-Anhalt, 39120

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-α) Inhibitor Therapy

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with an existing medication called a tumour necrosis factor alpha inhibitor

The primary objective of this study was to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active rheumatoid arthritis (RA) inadequately controlled by TNF-α inhibitor (TNFi) therapy.

Read the detailed description

The goal of this Phase III study was to assess the efficacy, safety and tolerability of OKZ in subjects with moderately to severely active RA who had responded inadequately to TNFi therapy. The primary endpoint of the trial was assessed at Week 12. Olokizumab was expected to reduce the disease activity and improve physical function. The study was expected to provide safety information in a large group of subjects over at least a 24 week period.

This was a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. This study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety FollowUp Period from Week 24 to Week 44.

A total of 350 subjects were planned to be randomized.Subjects were assessed for eligibility to enter the study during a 4-week Screening Period. Eligible subjects were randomized at Visit 2 in a 2:2:1 ratio in one of 3 treatment groups (planned 140, 140, and 70 subjects per group, respectively) :

  1. Olokizumab 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo OKZ q4w to maintain blinding) + MTX for 24 weeks,
  2. Olokizumab 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX for 24 weeks or
  3. Placebo: SC injection of placebo q2w + MTX for 16 weeks.

Subjects who received placebo were re-randomized at Week 16 to receive 64 mg OKZ q4w + Methotrexate or 64 mg OKZ q2w +Methotrexate for 8 weeks.

Throughout the double-blind Treatment Period, all subjects were required to remain on a stable dose of background MTX with a stable route of administration. Concomitant treatment with folic acid was required for all subjects. The last dose of OKZ was administered at Week 20 for subjects receiving OKZ 64 mg q4w and at Week 22 for subjects receiving OKZ 64 mg q2w.

Following Visit 2 (randomization; Week 0), subjects returned to the study site at least every 2 weeks through Week 24 for response and safety assessments.

At Week 14, subjects who did not improve by at least 20% in both swollen and tender joint counts were classified as nonresponders and were administered sulfasalazine and/or hydroxychloroquine as rescue medication in addition to the assigned treatment.

After completion of the 24-week double-blind Treatment Period, subjects either rolled over into the long-term open-label extension (OLE) study or entered the Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for visits +4, +8, and +22 weeks after the last dose of study treatment.

Subjects who discontinued randomized treatment prematurely were required to come for the End of Treatment (EoT) Visit 2 weeks after the last study treatment administration and then continue with the scheduled study visits.

Adverse events (AEs) were assessed throughout the study (starting when the subject signed the informed consent form) and evaluated using the Common Terminology Criteria for Adverse Events Version 4.0. There was ongoing monitoring of safety events, including laboratory findings, by the Sponsor or the Sponsor's designee. In addition, safety was assessed throughout the study by an independent Data Safety Monitoring Board and potential major adverse cardiac events were evaluated by an independent Cardiovascular Adjudication Committee.

The study was conducted at 123 sites across 11 countries globally (in US,EU, Russian Federation, Asia, Latin America)

Being tested
Olokizumab, Placebo
Keywords
moderate Rheumatoid Arthritis, severe Rheumatoid Arthritis, Olokizumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • OlokizumabDrug

    160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial

  • PlaceboDrug

    sodium chloride 0.9% solution provided as either a 10 mL vial or ampoule, depending on market availability. Each placebo will be packed into a cardboard carton to contain 1 vial or ampoule

Study groups in NCT02760433
Study groupRoleWhat they receive
Arm 1: Olokizumab q4wExperimentalOlokizumab 64mg subcutaneous q4w + placebo + Methotrexate Olokizumab 64 mg subcutaneous q4w + placebo+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular) in order to maintain the blind, subjects randomized to receive OKZ q4w received placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)
Receives: Drug: Olokizumab; Drug: Placebo
Arm 2: Olokizumab q2wExperimentalOlokizumab 64mg subcutaneous q2w + Methotrexate 64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)
Receives: Drug: Olokizumab
Arm 3: Placebo q2wPlacebo comparatorPlacebo q2w subcutaneous + Methotrexate Placebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular) Starting at Week 16, all subjects in the placebo group were randomized in a blinded fashion to receive either OKZ 64 mg q2w or OKZ 64 mg q4w; equal numbers of subjects were planned to be assigned to each OKZ treatment group.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response

    The difference between OKZ and placebo in the percentage of subjects achieving an ACR20 response and remaining on randomized treatment and in the study at Week 12. A responder is defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12.

    American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures:

    • Patient Global Assessment of Disease Activity (VAS)
    • Patient Assessment of Pain (VAS)
    • HAQ-DI
    • Physician Global Assessment (VAS)
    • Level of acute phase reactant (CRP)

    Measured: at Week 12

Secondary outcomes (4)

  1. Percentage of Subjects Achieving Low Disease Activity

    Defined as Disease Activity Score 28-joint count (DAS28) C-reactive protein (CRP) <3.2, and remaining on randomized treatment and in the study at Week 12

    Measured: at Week 12

  2. Improvement of Physical Ability From Baseline to Week 12, as Measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)

    Change of physical ability from baseline (the last available assessment prior to the first dose of the study treatment) to week 12, as measured by HAQ-DI. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions.The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3 where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question. A decrease from baseline indicates improvement for HAQ-DI.The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. The HAQ-DI total score ranges from 0 (the best outcome) to 3 (the worst outcome).

    Measured: Baseline to Week 12

  3. Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response

    Difference between OKZ and placebo in the percentage of subjects achieving an ACR50 response and remaining on randomized treatment and in the study at Week 12.

    American College of Rheumatology 50% Response is a composite defined as ≥50%, improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥50%, improvement from baseline in at least 3 of the 5 remaining core set measures:

    • Patient Global Assessment of Disease Activity (VAS)
    • Patient Assessment of Pain (VAS)
    • HAQ-DI
    • Physician Global Assessment (VAS)
    • Level of acute phase reactant (CRP)

    Measured: at Week 12

  4. Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 (Remission)

    Difference between OKZ and placebo in the percentage of subjects with Clinical Disease Activity Index (CDAI) ≤2.8 (remission) and remaining on randomized treatment and in the study at Week 12

    Measured: at Week 12

Timeline

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

  1. First posted3 May 2016 (estimated)
  2. Study start25 Jan 2017
  3. Primary completion12 Sep 2019
  4. Study completion1 Oct 2019

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
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760433
Sponsor's protocol ID
CL04041025
Other IDs
2015-005308-27, 2015
Acronym
CREDO 3
Status last verified
Sep 2023
First submitted
29 Apr 2016
Last updated
21 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Fleischmann RM, Strand V, Feist E, Lisitsyna T, Sparks JA, Nasonov E, Samsonov M, Grishin S, Egorova A, Kuzkina S, Smolen JS. Olokizumab Improves Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis up to 106 Weeks (Results from the Open-Label Extension of Phase III Randomized Clinical Trials). Rheumatol Ther. 2026 Aug;13(4):1055-1074. doi: 10.1007/s40744-026-00852-3. Epub 2026 May 16.

    PubMed 42142212

  • Feist E, Fatenejad S, Grishin S, Korneva E, Luggen ME, Nasonov E, Samsonov M, Smolen JS, Fleischmann RM. Olokizumab, a monoclonal antibody against interleukin-6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by tumour necrosis factor inhibitor therapy: efficacy and safety results of a randomised controlled phase III study. Ann Rheum Dis. 2022 Dec;81(12):1661-1668. doi: 10.1136/ard-2022-222630. Epub 2022 Sep 15.

    PubMed 36109142

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olokizumab in people with Rheumatoid Arthritis, run by R-Pharm International, LLC at 116 sites in 11 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 14 inclusion and 43 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Argentina, Brazil, Mexico, Russia and 6 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 21 Jul 2021). 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 Subjects Achieving American College of Rheumatology 20% (ACR20) Response (time frame: at Week 12). 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 NCT02760433, which also lists 2 linked publications.

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 21 Sep 2023.

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