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
CREDO 2
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
1 other identifier
interventional
1,648
18 countries
203
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Jun 2016
Typical duration for phase_3 rheumatoid-arthritis
203 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedStudy Start
First participant enrolled
June 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2019
CompletedResults Posted
Study results publicly available
April 30, 2021
CompletedSeptember 21, 2023
September 1, 2023
3.2 years
April 29, 2016
January 25, 2021
September 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
at Week 12
Secondary Outcomes (6)
Percentage of Subjects Achieving ACR20 Response: Olokizumab Comparison With Adalimumab
at Week 12
Percentage of Subjects Achieving Low Disease Activity
at Week 12
Percentage of Subjects Achieving Low Disease Activity: Olokizumab Comparison With Adalimumab
at Week 12
Improvement of Physical Ability From Baseline to Week 12, as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Baseline to Week 12
Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response
at Week 24
- +1 more secondary outcomes
Study Arms (4)
Arm 1: Olokizumab q4w
EXPERIMENTALOlokizumab 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.)
Arm 2: Olokizumab q2w
EXPERIMENTALOlokizumab 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)
Arm 3: Adalimumab q2w
ACTIVE 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)
Arm 4: Placebo q2w
PLACEBO 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)
Interventions
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial
0.4 or 0.8 mL prefilled, single-dose syringe
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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):
- weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline
- 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
- 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
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Pharm International, LLClead
- Quintiles, Inc.collaborator
- OCT Clinical Trialscollaborator
Study Sites (203)
Arizona Arthritis & Rheumatology Associates, P.C.
Mesa, Arizona, 85210, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, 85032, United States
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona, 85351, United States
Medvin Clinical Research
Covina, California, 91722, United States
TriWest Research Associates
El Cajon, California, 92020, United States
MD Med Corp.
Hemet, California, 92543, United States
Valerius Medical Group
Los Alamitos, California, 90720-5403, United States
Rheumatology Center of San Diego
San Diego, California, 92128, United States
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, 94578, United States
Pacific Arthritis Center Medical Grpoup
Santa Maria, California, 93454, United States
Inland Rheumatology Clinical Trials
Upland, California, 91786, United States
Center for Rheumatology Research
West Hills, California, 91607, United States
Medvin Clinical Research
Whittier, California, 90602, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
New England Research Associates LLC
Bridgeport, Connecticut, 6606, United States
Javed Rheumatology Associates
Newark, Delaware, 19713, United States
RASF - Clinical Research Center
Boca Raton, Florida, 33486, United States
Reliable Clinical Research, LLC
Hialeah, Florida, 33012, United States
Pharmax Research Clinic, Inc.
Miami, Florida, 33126, United States
Medical Research Center of Miami
Miami, Florida, 33134, United States
Omega Research Consultants
Orlando, Florida, 32810, United States
Arthritis Research
Palm Harbor, Florida, 34684, United States
Family Clinical Trials, LLC.
Pembroke Pines, Florida, 33026, United States
AdventHealth Medical Group, PA
Tampa, Florida, 33614, United States
Lovelace Scientific Resources, Inc.
Venice, Florida, 34292, United States
Arthritis Center of North Georgia
Gainesville, Georgia, 30501, United States
Marietta Rheumatology Associates, PC
Marietta, Georgia, 30060, United States
Institute of Arthritis Research
Idaho Falls, Idaho, 83404, United States
Springfield Clinic, LLP
Springfield, Illinois, 62702, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
The Arthritis & Diabetes Clinic, Inc.
Monroe, Louisiana, 71203, United States
Klein and Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc, Michigan, 48439, United States
North MS Medical Clinics, Inc.
Tupelo, Mississippi, 38801, United States
Glacier View Research Instutute-Rheumatology
Kalispell, Montana, 59901, United States
Physician Resrch Collaboration
Lincoln, Nebraska, 68516, United States
Arthritis & Osteoporosis Associates, PA
Freehold, New Jersey, 07728, United States
NYU Langone ambulatory care
Brooklyn, New York, 11201, United States
Medication Management, LLC
Greensboro, North Carolina, 27408, United States
Cape Fear Arthritis Care
Leland, North Carolina, 28451, United States
Trinity Medical Group
Minot, North Dakota, 58701, United States
STAT Research, Inc.
Dayton, Ohio, 45417, United States
Clinical Research Source, Inc.
Toledo, Ohio, 43606, United States
Health Research of Oklahoma, PLLC
Oklahoma City, Oklahoma, 73103, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Altoona Center for Clinical Research, P.C.
Duncansville, Pennsylvania, 16635, United States
Low Country Rheumatology, PA
Summerville, South Carolina, 29486, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Austin Regional Clinic, P.A.
Austin, Texas, 78731, United States
Accurate Clinical Management LLC
Baytown, Texas, 77521, United States
Pioneer Research Solutions, Inc.
Beaumont, Texas, 77702, United States
Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, 76034, United States
Rheumatology Clinic of Houston, P.A.
Houston, Texas, 77065, United States
Accurate Clinical Research
Houston, Texas, 77084, United States
Accurate Clinical Mangemnt LLC
Houston, Texas, 77089, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77089, United States
Advanced Rheumatology of Houston
Houston, Texas, 77382, United States
Accurate Clinical Research, Inc.
League City, Texas, 77573, United States
Endocrinology, Internal Medicine
Lubbock, Texas, 79410, United States
Dr. Alex De Jesus Rheumatology, P.A.
San Antonio, Texas, 78229, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204, United States
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FYK, Argentina
Instituto de Investigaciones Clinicas-Mar del Plata
Mar del Plata, Buenos Aires, B7600FZN, Argentina
Instituto Medico CER
Quilmes, Buenos Aires, B1878DVB, Argentina
Clinica de Higado y Aparato Digestivo
Rosario, Santa Fe Province, S2000CFJ, Argentina
Sanatorio San Martin
Venado Tuerto, Santa Fe Province, S2600KUE, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, T4000BRD, Argentina
Institute Investigaciones Clinc Quilme
Buenos Aires, B1878GEG, Argentina
Atencion Integral en Reumatologia (AIR)
Ciudad Autonoma Buenos Aires, 1426, Argentina
Organizacion Medica de Investigacion (OMI)
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
APRILLUS Asistencia e Investigacion
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
Instituto Centenario
Ciudad Autonoma Buenos Aires, C1204AAD, Argentina
Hospital Privado Centro Medico de Cordoba S.A
Córdoba, 5016, Argentina
Instituto DAMIC Fundacion Rusculleda
Córdoba, X5003DCE, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, 5400, Argentina
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, 60430-370, Brazil
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, 29055450, Brazil
CIP - Centro Internacional de Pesquisa
Goiânia, Goiás, 74110-120, Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570, Brazil
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
Curitiba, Paraná, 80030-110, Brazil
Clinilive - Clínica do Idoso e Pesquisa Clínica
Maringá, Paraná, 87013-250, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-010, Brazil
LMK Serviços Médicos S/S Ltda
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC
São Bernardo do Campo, São Paulo, 09715-090, Brazil
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
Rio de Janeiro, 20241-180, Brazil
Clínica de Neoplasias Litoral
Santa Catarina, 88301-215, Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda.
São Paulo, 01228-200, Brazil
Hospital Abreu Sodré - AACD
São Paulo, 04032-060, Brazil
UMHAT Pulmed OOD
Plovdiv, 4000, Bulgaria
MHAT - Ruse, AD
Rousse, 7002, Bulgaria
Medizinski Zentar-1-Sevlievo EOOD
Sevlievo, 5400, Bulgaria
MHAT - Shumen, AD
Shumen, 9700, Bulgaria
NMTH "Tsar Boris III"
Sofia, 1233, Bulgaria
MHAT "Lyulin", EAD
Sofia, 1336, Bulgaria
Medical Center "Excelsior", OOD
Sofia, 1407, Bulgaria
UMHAT Sv. Ivan Rilski EAD
Sofia, 1431, Bulgaria
MC Synexus - Sofia EOOD
Sofia, 1784, Bulgaria
MDHAT 'Dr. Stefan Cherkezov', AD
Veliko Tarnovo, 5000, Bulgaria
Centro de Investigacion Medico
Barranquilla, Atlántico, 080020, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
Bogotá, 110221, Colombia
Fundacion Instituto de Reumatologia Fernando Chalem
Bogotá, 111211, Colombia
Medicity S.A.S.
Bucaramanga, 680003, Colombia
Clinica de Artritis Temprana S.A.
Cali, 76001, Colombia
CCR Brno s.r.o
Brno, 60200, Czechia
Revmatologie s.r.o.
Brno, 638 00, Czechia
Nemocnice Jihlava p.o
Jihlava, 586 01, Czechia
MUDr. Gabriela Simkova ordinace lekare specialisty interna revmatologie
Kladno, 272 01, Czechia
CTCenter MaVe s.r.o.
Olomouc, 77900, Czechia
Vesalion s.r.o.
Ostrava, 70200, Czechia
Artroscan s.r.o.
Ostrava - Trebovice, 722 00, Czechia
ARTHROHELP s.r.o.
Pardubice, 530 02, Czechia
CCR Pardubice
Pardubice, 530 02, Czechia
Clintrial, s.r.o.
Prague, 100 00, Czechia
Revmatologicky ustav
Prague, 128 00, Czechia
CCR Prague s.r.o.
Prague, 130 00, Czechia
MUDR. Zuzana Urbanova Revmatologie
Prague, 140 00, Czechia
Affidea Praha, s.r.o.
Prague, 148 00, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
MUDR. Zuzana URBANOVA Revmatologie
Praha 4 Nusle, 140 00, Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, 686 01, Czechia
PV Medical Services s.r.o.
Zlín, 760 01, Czechia
East Tallinn Central Hospital
Tallinn, 11312, Estonia
Medita Kliinik OÜ
Tartu, 50406, Estonia
Kerckhoff-Klinik gGmbH
Bad Nauheim, Hesse, 61231, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, 39120, Germany
Rheumapraxis Dr. med. Reiner Kurthen
Aachen, Westfalen, 52064, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, 20095, Germany
Studienambulanz Dr. Wassenberg
Northeim, 40878, Germany
Principal SMO Kft.
Baja, 6500, Hungary
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, 8230, Hungary
Clinexpert Egeszsegugyi Szolg. es Ker. Kft.
Budapest, 1033, Hungary
Obudai Egeszsegugyi Centrum
Budapest, 1036, Hungary
Kiskunhalasi Semmelweis Korhaz
Kiskunhalas, 6400, Hungary
DRC Szekesfehervar
Székesfehérvár, 8000, Hungary
MAV Korhaz és Rendelointezet
Szolnok, 5000, Hungary
Vital Medical Center
Veszprém, 8200, Hungary
Dr.Saulite-Kandevica Private Practice
Liepāja, LV-3401, Latvia
Alytаus Regional S. Kudirkos Hospital, Public Institution
Alytus, 62114, Lithuania
Republican Kaunas Hospital, Public Institution
Kaunas, 45130, Lithuania
Klaipeda University Hospital, Public Institution
Klaipėda, 92288, Lithuania
Siauliai Republican Hospital, Public Institution
Šiauliai, 76231, Lithuania
Center Outpatient Clinic, Public Institution
Vilnius, LT-01117, Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution
Vilnius, LT-08661, Lithuania
Centro de Investigacion Clínica GRAMEL S.C
México, DisMexicotrito Federal, 03720, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, 44650, Mexico
Centro de Estudios de Investigacion Basica y Clinica SC
Guadalajara, Jalisco, 44690, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, 06700, Mexico
Clinicos Asociados BOCM S.C.
Mexico City, Mexico City, 3300, Mexico
Cryptex Investigacion Clinica S.C
Mexico City, Mexico City, 6100, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, Nuevo León, 64000, Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Clinical Research Institute S.C.
México, State of Mexico, 54055, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, 31000, Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
San Luis Potosí City, 78213, Mexico
NZOZ ZDROWIE Osteo-Medic
Bialystok, 15-351, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, 85-168, Poland
MCBK Iwona Czajkowska Anna PodrażkaSzczepaniak S.C.
Grodzisk Mazowiecki, 05-825, Poland
Polimedica Centrum Badań, Profilaktyki I Leczenia
Kielce, 25-355, Poland
Centrum Medyczne AMED
Lodz, 91-363, Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, 10-117, Poland
Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego
Sieradz, 98-200, Poland
CCBR - Lodz - PL
Skierniewice, 90 368, Poland
Clinmed Research
Skierniewice, 96-100, Poland
RCMed
Sochaczew, 96-500, Poland
KO-MED Centra Kliniczne Staszow
Staszów, 28-200, Poland
Samodzielny Publiczny ZOZ Tomaszow Lubelski
Tomaszów Lubelski, 22-600, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
Torun, 87-100, Poland
Medycyna Kliniczna
Warsaw, 00-874, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, 02-118, Poland
McM Polimedica
Warsaw, 02-777, Poland
KO-MED Centra Kliniczne Zamosc
Zamość, 22-400, Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Zgierz, 95-100, Poland
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
Constanța, 900591, Romania
Hospital n a Kuvatov
Ufa, Bashkortostan Republic, 450005, Russia
SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit
Saint Petersburg, Leningradskaya Oblast', 190068, Russia
FSBEI HE "FMSMU n.a. I.M. Sechenov of MoH of RF", University Hospital #2, Departament of New Drugs Introduction
Moscow, Moscovskaya Oblast, 119435, Russia
State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department
Moscow, Moscow Oblast, 111539, Russia
SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia
SBHI of Republic of Karelia "Republican Hospital named after V.A.Baranov"
Petrozavodsk, Republic of Karelia, 185019, Russia
Non-govarnmental Healtheare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways"
Smolensk, Smolensk Oblast, 214025, Russia
State Budgetary Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital #1"
Yekaterinburg, Sverdlovsk Oblast, 620102, Russia
SBEI HPE "Ural State Medical University" of MoH of RF based MBI "Central City Clinical Hospital #6"
Yekaterinburg, Sverdlovsk Oblast, 620149, Russia
Institute n a Nasonova
Moscow, 115522, Russia
Eulji University Hospital
Daejeon, 35233, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
CHA Bundang Medical Center
Gyeonggi-do, 13496, South Korea
Jeju National University Hospital
Jeju City, 63241, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chi Mei Medical Center
Tainan, 710, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 333, Taiwan
Torbay Hospital
Torquay, Devon, TQ2 7AA, United Kingdom
Whipps Cross University Hospital
London, Greater London, E11 1NR, United Kingdom
Royal Free Hospital
London, Greater London, NW3 2QG, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, RG24 9NA, United Kingdom
Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, Merseyside, CH49 5PE, United Kingdom
Related Publications (1)
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.
PMID: 36001712DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maria Lemak, Scientific Advisor
- Organization
- R-Pharm
Study Officials
- STUDY DIRECTOR
Mikhail Samsonov
R-Pharm
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2016
First Posted
May 3, 2016
Study Start
June 6, 2016
Primary Completion
August 2, 2019
Study Completion
November 5, 2019
Last Updated
September 21, 2023
Results First Posted
April 30, 2021
Record last verified: 2023-09