AzTrials
AzTrials

Rheumatoid ArthritisPhase 3CREDO 2NCT02760407

Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

A Phase 3 study testing Olokizumab 64mg q4w, Olokizumab 64mg q2w and Adalimumab 40mg q2w in people with Rheumatoid Arthritis, run by R-Pharm International, LLC at 203 sites in 18 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 methotrexate (MTX). 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 64mg q4w, Olokizumab 64mg q2w and Adalimumab 40mg q2w
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,648 participants
Where
203 sitesin 18 countries
Study dates
6 Jun 2016to 5 Nov 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 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 12 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)
  • Inadequate response to treatment with oral, SC, or intramuscular MTX (defined as a subject with at least 12 weeks of exposure prior to Screening and with either absence of any documented clinically significant response, or documented initial clinical response with subsequent loss of that response or partial response) for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if intolerant to higher doses). The dose and route of administering MTX had to have been stable for at least 6 weeks prior to Screening. A lower dose of MTX (≥7.5 mg/week) was permitted for subjects enrolled in the Republic of Korea, consistent with local clinical practice.
  • 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
  • CRP above the normal range (ULN) at Screening based on the central laboratory results.

Who cannot join

  • Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (eg, gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus). However, subjects could 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 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)
  • Prior use of bDMARDs
  • Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline
Show all 36Show fewer
  • 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 are positive for hepatitis B surface antibodies (anti-HBs), but negative for HBsAg and anti-HBc, will be eligible
  • Subjects with human immunodeficiency virus (HIV) infection
  • Subjects with:
  • Suspected or confirmed current active 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
  • 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 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.
  • Subjects with a known hypersensitivity to any component of the OKZ drug product, adalimumab, 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
  • 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

203 sites in 18 countries.

203 sites in 18 countries

United States64 sites

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Austin Regional Clinic, P.A.

    Austin, Texas, 78731

  • Accurate Clinical Management LLC

    Baytown, Texas, 77521

  • Pioneer Research Solutions, Inc.

    Beaumont, Texas, 77702

  • RASF - Clinical Research Center

    Boca Raton, Florida, 33486

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • New England Research Associates LLC

    Bridgeport, Connecticut, 6606

  • NYU Langone ambulatory care

    Brooklyn, New York, 11201

  • Medvin Clinical Research

    Covina, California, 91722

  • STAT Research, Inc.

    Dayton, Ohio, 45417

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Altoona Center for Clinical Research, P.C.

    Duncansville, Pennsylvania, 16635

  • TriWest Research Associates

    El Cajon, California, 92020

  • Arthritis & Osteoporosis Associates, PA

    Freehold, New Jersey, 07728

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • AA MRC LLC Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439

  • 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

  • MD Med Corp.

    Hemet, California, 92543

  • Reliable Clinical Research, LLC

    Hialeah, Florida, 33012

  • Rheumatology Clinic of Houston, P.A.

    Houston, Texas, 77065

  • Accurate Clinical Research

    Houston, Texas, 77084

  • Accurate Clinical Mangemnt LLC

    Houston, Texas, 77089

  • Accurate Clinical Research, Inc.

    Houston, Texas, 77089

  • Advanced Rheumatology of Houston

    Houston, Texas, 77382

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • Glacier View Research Instutute-Rheumatology

    Kalispell, Montana, 59901

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Accurate Clinical Research, Inc.

    League City, Texas, 77573

  • Cape Fear Arthritis Care

    Leland, North Carolina, 28451

  • Physician Resrch Collaboration

    Lincoln, Nebraska, 68516

  • Valerius Medical Group

    Los Alamitos, California, 90720-5403

  • Endocrinology, Internal Medicine

    Lubbock, Texas, 79410

  • Marietta Rheumatology Associates, PC

    Marietta, Georgia, 30060

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Mesa, Arizona, 85210

  • Pharmax Research Clinic, Inc.

    Miami, Florida, 33126

  • Medical Research Center of Miami

    Miami, Florida, 33134

  • Trinity Medical Group

    Minot, North Dakota, 58701

  • The Arthritis & Diabetes Clinic, Inc.

    Monroe, Louisiana, 71203

  • Javed Rheumatology Associates

    Newark, Delaware, 19713

  • Health Research of Oklahoma, PLLC

    Oklahoma City, Oklahoma, 73103

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Omega Research Consultants

    Orlando, Florida, 32810

  • Arthritis Research

    Palm Harbor, Florida, 34684

  • Family Clinical Trials, LLC.

    Pembroke Pines, Florida, 33026

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona, 85032

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

    San Antonio, Texas, 78229

  • Rheumatology Center of San Diego

    San Diego, California, 92128

  • East Bay Rheumatology Medical Group, Inc.

    San Leandro, California, 94578

  • Pacific Arthritis Center Medical Grpoup

    Santa Maria, California, 93454

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • Springfield Clinic, LLP

    Springfield, Illinois, 62702

  • Low Country Rheumatology, PA

    Summerville, South Carolina, 29486

  • Arizona Arthritis & Rheumatology Research, PLLC

    Sun City, Arizona, 85351

  • AdventHealth Medical Group, PA

    Tampa, Florida, 33614

  • Clinical Research Source, Inc.

    Toledo, Ohio, 43606

  • DM Clinical Research

    Tomball, Texas, 77375

  • North MS Medical Clinics, Inc.

    Tupelo, Mississippi, 38801

  • Inland Rheumatology Clinical Trials

    Upland, California, 91786

  • Lovelace Scientific Resources, Inc.

    Venice, Florida, 34292

  • Center for Rheumatology Research

    West Hills, California, 91607

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Medvin Clinical Research

    Whittier, California, 90602

Other trials in United States

Czechia18 sites

  • CCR Brno s.r.o

    Brno, 60200

  • Revmatologie s.r.o.

    Brno, 638 00

  • Nemocnice Jihlava p.o

    Jihlava, 586 01

  • MUDr. Gabriela Simkova ordinace lekare specialisty interna revmatologie

    Kladno, 272 01

  • CTCenter MaVe s.r.o.

    Olomouc, 77900

  • Vesalion s.r.o.

    Ostrava, 70200

  • Artroscan s.r.o.

    Ostrava - Trebovice, 722 00

  • ARTHROHELP s.r.o.

    Pardubice, 530 02

  • CCR Pardubice

    Pardubice, 530 02

  • Clintrial, s.r.o.

    Prague, 100 00

  • Revmatologicky ustav

    Prague, 128 00

  • CCR Prague s.r.o.

    Prague, 130 00

  • MUDR. Zuzana Urbanova Revmatologie

    Prague, 140 00

  • Affidea Praha, s.r.o.

    Prague, 148 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • MUDR. Zuzana URBANOVA Revmatologie

    Praha 4 Nusle, 140 00

  • MEDICAL PLUS s.r.o.

    Uherské Hradiště, 686 01

  • PV Medical Services s.r.o.

    Zlín, 760 01

Other trials in Czechia

Poland18 sites

  • NZOZ ZDROWIE Osteo-Medic

    Bialystok, 15-351

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 85-168

  • MCBK Iwona Czajkowska Anna PodrażkaSzczepaniak S.C.

    Grodzisk Mazowiecki, 05-825

  • Polimedica Centrum Badań, Profilaktyki I Leczenia

    Kielce, 25-355

  • Centrum Medyczne AMED

    Lodz, 91-363

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117

  • Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego

    Sieradz, 98-200

  • CCBR - Lodz - PL

    Skierniewice, 90 368

  • Clinmed Research

    Skierniewice, 96-100

  • RCMed

    Sochaczew, 96-500

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28-200

  • Samodzielny Publiczny ZOZ Tomaszow Lubelski

    Tomaszów Lubelski, 22-600

  • Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z

    Torun, 87-100

  • Medycyna Kliniczna

    Warsaw, 00-874

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warsaw, 02-118

  • McM Polimedica

    Warsaw, 02-777

  • KO-MED Centra Kliniczne Zamosc

    Zamość, 22-400

  • Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Zgierz, 95-100

Other trials in Poland

Argentina15 sites

  • Institute Investigaciones Clinc Quilme

    Buenos Aires, B1878GEG

  • Atencion Integral en Reumatologia (AIR)

    Ciudad Autonoma Buenos Aires, 1426

  • Organizacion Medica de Investigacion (OMI)

    Ciudad Autonoma Buenos Aires, C1015ABO

  • APRILLUS Asistencia e Investigacion

    Ciudad Autonoma Buenos Aires, C1046AAQ

  • Instituto Centenario

    Ciudad Autonoma Buenos Aires, C1204AAD

  • Hospital Privado Centro Medico de Cordoba S.A

    Córdoba, 5016

  • Instituto DAMIC Fundacion Rusculleda

    Córdoba, X5003DCE

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FYK

  • Instituto de Investigaciones Clinicas-Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZN

  • Instituto Medico CER

    Quilmes, Buenos Aires, B1878DVB

  • Clinica de Higado y Aparato Digestivo

    Rosario, Santa Fe Province, S2000CFJ

  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

    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

Brazil14 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

  • Clinilive - Clínica do Idoso e Pesquisa Clínica

    Maringá, Paraná, 87013-250

  • LMK Serviços Médicos S/S Ltda

    Porto Alegre, Rio Grande do Sul, 90480-000

  • CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

    Rio de Janeiro, 20241-180

  • Clínica de Neoplasias Litoral

    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

  • Hospital Abreu Sodré - AACD

    São Paulo, 04032-060

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055450

Other trials in Brazil

Mexico11 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

    México, DisMexicotrito Federal, 03720

  • Clinical Research Institute S.C.

    México, State of Mexico, 54055

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 06700

  • Clinicos Asociados BOCM S.C.

    Mexico City, Mexico City, 3300

  • Cryptex Investigacion Clinica S.C

    Mexico City, Mexico City, 6100

  • 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, 78213

Other trials in Mexico

Bulgaria10 sites

  • UMHAT Pulmed OOD

    Plovdiv, 4000

  • MHAT - Ruse, AD

    Rousse, 7002

  • Medizinski Zentar-1-Sevlievo EOOD

    Sevlievo, 5400

  • MHAT - Shumen, AD

    Shumen, 9700

  • NMTH "Tsar Boris III"

    Sofia, 1233

  • MHAT "Lyulin", EAD

    Sofia, 1336

  • Medical Center "Excelsior", OOD

    Sofia, 1407

  • UMHAT Sv. Ivan Rilski EAD

    Sofia, 1431

  • MC Synexus - Sofia EOOD

    Sofia, 1784

  • MDHAT 'Dr. Stefan Cherkezov', AD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Russia10 sites

  • FSBEI HE "FMSMU n.a. I.M. Sechenov of MoH of RF", University Hospital #2, Departament of New Drugs Introduction

    Moscow, Moscovskaya Oblast, 119435

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

    Moscow, Moscow Oblast, 111539

  • Institute n a Nasonova

    Moscow, 115522

  • SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126

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

    Petrozavodsk, Republic of Karelia, 185019

  • SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit

    Saint Petersburg, Leningradskaya Oblast', 190068

  • Non-govarnmental Healtheare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways"

    Smolensk, Smolensk Oblast, 214025

  • Hospital n a Kuvatov

    Ufa, Bashkortostan Republic, 450005

  • State Budgetary Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital #1"

    Yekaterinburg, Sverdlovsk Oblast, 620102

  • SBEI HPE "Ural State Medical University" of MoH of RF based MBI "Central City Clinical Hospital #6"

    Yekaterinburg, Sverdlovsk Oblast, 620149

Other trials in Russia

Hungary8 sites

  • Principal SMO Kft.

    Baja, 6500

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, 8230

  • Clinexpert Egeszsegugyi Szolg. es Ker. Kft.

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum

    Budapest, 1036

  • Kiskunhalasi Semmelweis Korhaz

    Kiskunhalas, 6400

  • DRC Szekesfehervar

    Székesfehérvár, 8000

  • MAV Korhaz és Rendelointezet

    Szolnok, 5000

  • Vital Medical Center

    Veszprém, 8200

Other trials in Hungary

Germany6 sites

  • Rheumapraxis Dr. med. Reiner Kurthen

    Aachen, Westfalen, 52064

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, Hesse, 61231

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • HRF Hamburger Rheuma Forschungszentrum

    Hamburg, 20095

  • SMO.MD GmbH

    Magdeburg, Saxony-Anhalt, 39120

  • Studienambulanz Dr. Wassenberg

    Northeim, 40878

Other trials in Germany

Lithuania6 sites

  • Alytаus Regional S. Kudirkos Hospital, Public Institution

    Alytus, 62114

  • Republican Kaunas Hospital, Public Institution

    Kaunas, 45130

  • Klaipeda University Hospital, Public Institution

    Klaipėda, 92288

  • Siauliai Republican Hospital, Public Institution

    Šiauliai, 76231

  • Center Outpatient Clinic, Public Institution

    Vilnius, LT-01117

  • Vilnius University Hospital Santariskiu Clinic, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

South Korea6 sites

  • Eulji University Hospital

    Daejeon, 35233

  • Chonnam National University Hospital

    Gwangju, 61469

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Jeju National University Hospital

    Jeju City, 63241

  • Severance Hospital, Yonsei University

    Seoul, 03722

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

United Kingdom6 sites

  • Basingstoke and North Hampshire Hospital

    Basingstoke, Hampshire, RG24 9NA

  • Whipps Cross University Hospital

    London, Greater London, E11 1NR

  • Royal Free Hospital

    London, Greater London, NW3 2QG

  • Maidstone Hospital

    Maidstone, Kent, ME16 9QQ

  • Arrowe Park Hospital

    Metropolitan Borough of Wirral, Merseyside, CH49 5PE

  • Torbay Hospital

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Colombia5 sites

  • Centro de Investigacion Medico

    Barranquilla, Atlántico, 080020

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

    Bogotá, 110221

  • Fundacion Instituto de Reumatologia Fernando Chalem

    Bogotá, 111211

  • Medicity S.A.S.

    Bucaramanga, 680003

  • Clinica de Artritis Temprana S.A.

    Cali, 76001

Other trials in Colombia

Estonia2 sites

  • East Tallinn Central Hospital

    Tallinn, 11312

  • Medita Kliinik OÜ

    Tartu, 50406

Other trials in Estonia

Taiwan2 sites

  • Chi Mei Medical Center

    Tainan, 710

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

Other trials in Taiwan

Latvia1 site

  • Dr.Saulite-Kandevica Private Practice

    Liepāja, LV-3401

Other trials in Latvia

Romania1 site

  • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta

    Constanța, 900591

Other trials in Romania

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate 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 methotrexate (MTX).

The primary objective of this study was to evaluate the efficacy of 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 RA inadequately controlled by MTX therapy.

The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX 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 MTX. The primary endpoint of the trial was 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 study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety Follow-Up Period from Week 24 to Week 44. Subjects were assessed for eligibility to enter the study during the 4-week Screening Period. A total of 1575 subjects were planned to be randomly assigned to 1 of 4 treatment groups in a 2:2:2:1 ratio (450, 450, 450, and 225 subjects per group, respectively):

  1. Olokizumab 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo q4w to maintain blinding) + MTX
  2. Olokizumab 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX
  3. Adalimumab 40 mg q2w: SC injection of adalimumab 40 mg q2w + MTX
  4. Placebo: SC injection of placebo q2w + MTX

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 study treatment (OKZ, adalimumab, or placebo) was at Week 22 in all groups.

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 had not improved 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 had 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 208 sites across 18 countries globally (in US, European Union (EU),United Kingdom (UK), Russian Federation, Asia, Latin America).

Being tested
Olokizumab 64mg q4w, Olokizumab 64mg q2w, Adalimumab 40mg q2w, Placebo q2w
Keywords
moderate Rheumatoid Arthritis, severe Rheumatoid Arthritis, subcutaneous, 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.

  • Olokizumab 64mg q4wDrug

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

  • Olokizumab 64mg q2wDrug

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

  • Adalimumab 40mg q2wDrug

    Also called Humira

    0.4 or 0.8 mL prefilled, single-dose syringe

  • Placebo q2wDrug

    sodium chloride 0.9% solution supplied in 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 NCT02760407
Study groupRoleWhat they receive
Arm 1: Olokizumab q4wExperimentalOlokizumab 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 64mg q4w; Drug: Placebo q2w
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 64mg q2w
Arm 3: Adalimumab q2wActive comparatorAdalimumab 40mg q2w subcutaneous + Methotrexate Subjects were administered adalimumab 40 mg q2w via SC injection as an active comparator+ concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular)
Receives: Drug: Adalimumab 40mg q2w
Arm 4: 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)
Receives: Drug: Placebo q2w

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. (where a responder was defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12) This endpoint served to demonstrate that the efficacy of OKZ was superior to placebo. 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 (6)

  1. Percentage of Subjects Achieving ACR20 Response: Olokizumab Comparison With Adalimumab

    A responder was defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12.This endpoint served to demonstrate that the efficacy of OKZ was non-inferior to adalimumab, provided that superiority of adalimumab to placebo (assay sensitivity) was demonstrated concurrently based on the same endpoint.

    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

  2. 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

  3. Percentage of Subjects Achieving Low Disease Activity: Olokizumab Comparison With Adalimumab

    Percentage of subjects achieving low disease activity, defined as DAS28 (CRP) <3.2, and remaining on randomized treatment and in the study at Week 12; served to demonstrate that the efficacy of OKZ was noninferior to adalimumab, provided that superiority of adalimumab to placebo (assay sensitivity) was demonstrated concurrently based on the same endpoint

    Measured: at Week 12

  4. 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

  5. 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 24

    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 24

  6. 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 24

    Measured: at Week 24

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 start6 Jun 2016
  3. Primary completion2 Aug 2019
  4. Study completion5 Nov 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
1,648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760407
Sponsor's protocol ID
CL04041023
Acronym
CREDO 2
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, Luggen ME, Nasonov EL, Yakushin SS, Bukhanova DV, Egorova AN, Grishin SA, Samsonov MY, Smolen JS. The impact of comorbidities on the efficacy of IL-6 inhibitor olokizumab compared to adalimumab in a randomized controlled trial. Arthritis Res Ther. 2025 Nov 14;27(1):213. doi: 10.1186/s13075-025-03682-w.

    PubMed 41239458

  • Smolen JS, Feist E, Fatenejad S, Grishin SA, Korneva EV, Nasonov EL, Samsonov MY, Fleischmann RM; CREDO2 Group. Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2022 Aug 25;387(8):715-726. doi: 10.1056/NEJMoa2201302.

    PubMed 36001712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olokizumab 64mg q4w, Olokizumab 64mg q2w and Adalimumab 40mg q2w in people with Rheumatoid Arthritis, run by R-Pharm International, LLC at 203 sites in 18 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 8 inclusion and 36 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 203 sites in United States, Czechia, Poland, Argentina, Brazil and 13 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 30 Apr 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 NCT02760407, which also lists 3 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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