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

NCT ID: NCT02760407

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1648 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-06
• Study Completion Date: 2019-11-05

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.

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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: Olokizumab q4w

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.)

Group Type: EXPERIMENTAL

Olokizumab 64mg q4w

Intervention Type: DRUG

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

Placebo q2w

Intervention Type: DRUG

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

Arm 2: Olokizumab q2w

Olokizumab 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)

Group Type: EXPERIMENTAL

Olokizumab 64mg q2w

Intervention Type: DRUG

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

Arm 3: Adalimumab q2w

Adalimumab 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)

Group Type: ACTIVE_COMPARATOR

Adalimumab 40mg q2w

Intervention Type: DRUG

0.4 or 0.8 mL prefilled, single-dose syringe

Arm 4: Placebo q2w

Placebo 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)

Group Type: PLACEBO_COMPARATOR

Placebo q2w

Intervention Type: DRUG

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

Interventions

Olokizumab 64mg q4w

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

Intervention Type: DRUG

Olokizumab 64mg q2w

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

Intervention Type: DRUG

Adalimumab 40mg q2w

0.4 or 0.8 mL prefilled, single-dose syringe

Intervention Type: DRUG

Placebo q2w

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

Intervention Type: DRUG

Other Intervention Names

Humira

Eligibility Criteria

Inclusion 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 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.

Exclusion Criteria

• 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):

1. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline

2. 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

3. 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:

1. Suspected or confirmed current active TB disease or a history of active TB disease

2. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

OCT Clinical Trials

OTHER

Sponsor Role: collaborator

R-Pharm International, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikhail Samsonov

Role: STUDY_DIRECTOR

R-Pharm

Locations

Arizona Arthritis & Rheumatology Associates, P.C.

Mesa, Arizona, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, United States

Medvin Clinical Research

Covina, California, United States

TriWest Research Associates

El Cajon, California, United States

MD Med Corp.

Hemet, California, United States

Valerius Medical Group

Los Alamitos, California, United States

Rheumatology Center of San Diego

San Diego, California, United States

East Bay Rheumatology Medical Group, Inc.

San Leandro, California, United States

Pacific Arthritis Center Medical Grpoup

Santa Maria, California, United States

Inland Rheumatology Clinical Trials

Upland, California, United States

Center for Rheumatology Research

West Hills, California, United States

Medvin Clinical Research

Whittier, California, United States

Denver Arthritis Clinic

Denver, Colorado, United States

New England Research Associates LLC

Bridgeport, Connecticut, United States

Javed Rheumatology Associates

Newark, Delaware, United States

RASF - Clinical Research Center

Boca Raton, Florida, United States

Reliable Clinical Research, LLC

Hialeah, Florida, United States

Pharmax Research Clinic, Inc.

Miami, Florida, United States

Medical Research Center of Miami

Miami, Florida, United States

Omega Research Consultants

Orlando, Florida, United States

Arthritis Research

Palm Harbor, Florida, United States

Family Clinical Trials, LLC.

Pembroke Pines, Florida, United States

AdventHealth Medical Group, PA

Tampa, Florida, United States

Lovelace Scientific Resources, Inc.

Venice, Florida, United States

Arthritis Center of North Georgia

Gainesville, Georgia, United States

Marietta Rheumatology Associates, PC

Marietta, Georgia, United States

Institute of Arthritis Research

Idaho Falls, Idaho, United States

Springfield Clinic, LLP

Springfield, Illinois, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Graves Gilbert Clinic

Bowling Green, Kentucky, United States

The Arthritis & Diabetes Clinic, Inc.

Monroe, Louisiana, United States

Klein and Associates, M.D., P.A.

Hagerstown, Maryland, United States

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States

AA MRC LLC Ahmed Arif Medical Research Center

Grand Blanc, Michigan, United States

North MS Medical Clinics, Inc.

Tupelo, Mississippi, United States

Glacier View Research Instutute-Rheumatology

Kalispell, Montana, United States

Physician Resrch Collaboration

Lincoln, Nebraska, United States

Arthritis & Osteoporosis Associates, PA

Freehold, New Jersey, United States

NYU Langone ambulatory care

Brooklyn, New York, United States

Medication Management, LLC

Greensboro, North Carolina, United States

Cape Fear Arthritis Care

Leland, North Carolina, United States

Trinity Medical Group

Minot, North Dakota, United States

STAT Research, Inc.

Dayton, Ohio, United States

Clinical Research Source, Inc.

Toledo, Ohio, United States

Health Research of Oklahoma, PLLC

Oklahoma City, Oklahoma, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Altoona Center for Clinical Research, P.C.

Duncansville, Pennsylvania, United States

Low Country Rheumatology, PA

Summerville, South Carolina, United States

Amarillo Center for Clinical Research

Amarillo, Texas, United States

Austin Regional Clinic, P.A.

Austin, Texas, United States

Accurate Clinical Management LLC

Baytown, Texas, United States

Pioneer Research Solutions, Inc.

Beaumont, Texas, United States

Precision Comprehensive Clinical Research Solutions

Grapevine, Texas, United States

Rheumatology Clinic of Houston, P.A.

Houston, Texas, United States

Accurate Clinical Research

Houston, Texas, United States

Accurate Clinical Mangemnt LLC

Houston, Texas, United States

Accurate Clinical Research, Inc.

Houston, Texas, United States

Advanced Rheumatology of Houston

Houston, Texas, United States

Accurate Clinical Research, Inc.

League City, Texas, United States

Endocrinology, Internal Medicine

Lubbock, Texas, United States

Dr. Alex De Jesus Rheumatology, P.A.

San Antonio, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Arthritis Northwest, PLLC

Spokane, Washington, United States

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas-Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto Medico CER

Quilmes, Buenos Aires, Argentina

Clinica de Higado y Aparato Digestivo

Rosario, Santa Fe Province, Argentina

Sanatorio San Martin

Venado Tuerto, Santa Fe Province, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, Argentina

Institute Investigaciones Clinc Quilme

Buenos Aires, , Argentina

Atencion Integral en Reumatologia (AIR)

Ciudad Autonoma Buenos Aires, , Argentina

Organizacion Medica de Investigacion (OMI)

Ciudad Autonoma Buenos Aires, , Argentina

APRILLUS Asistencia e Investigacion

Ciudad Autonoma Buenos Aires, , Argentina

Instituto Centenario

Ciudad Autonoma Buenos Aires, , Argentina

Hospital Privado Centro Medico de Cordoba S.A

Córdoba, , Argentina

Instituto DAMIC Fundacion Rusculleda

Córdoba, , Argentina

CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

San Juan, , Argentina

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

Fortaleza, Ceará, Brazil

CEDOES - Diagnóstico e Pesquisa

Vitória, Espírito Santo, Brazil

CIP - Centro Internacional de Pesquisa

Goiânia, Goiás, Brazil

CMiP - Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, Brazil

CETI - Centro de Estudos em Terapias Inovadoras Ltda.

Curitiba, Paraná, Brazil

Clinilive - Clínica do Idoso e Pesquisa Clínica

Maringá, Paraná, Brazil

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

LMK Serviços Médicos S/S Ltda

Porto Alegre, Rio Grande do Sul, Brazil

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Centro Multidisciplinar de Estudos Clínicos - CEMEC

São Bernardo do Campo, São Paulo, Brazil

CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

Rio de Janeiro, , Brazil

Clínica de Neoplasias Litoral

Santa Catarina, , Brazil

CPCLIN - Centro de Pesquisas Clínicas Ltda.

São Paulo, , Brazil

Hospital Abreu Sodré - AACD

São Paulo, , Brazil

UMHAT Pulmed OOD

Plovdiv, , Bulgaria

MHAT - Ruse, AD

Rousse, , Bulgaria

Medizinski Zentar-1-Sevlievo EOOD

Sevlievo, , Bulgaria

MHAT - Shumen, AD

Shumen, , Bulgaria

NMTH "Tsar Boris III"

Sofia, , Bulgaria

MHAT "Lyulin", EAD

Sofia, , Bulgaria

Medical Center "Excelsior", OOD

Sofia, , Bulgaria

UMHAT Sv. Ivan Rilski EAD

Sofia, , Bulgaria

MC Synexus - Sofia EOOD

Sofia, , Bulgaria

MDHAT 'Dr. Stefan Cherkezov', AD

Veliko Tarnovo, , Bulgaria

Centro de Investigacion Medico

Barranquilla, Atlántico, Colombia

Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM

Bogotá, , Colombia

Fundacion Instituto de Reumatologia Fernando Chalem

Bogotá, , Colombia

Medicity S.A.S.

Bucaramanga, , Colombia

Clinica de Artritis Temprana S.A.

Cali, , Colombia

CCR Brno s.r.o

Brno, , Czechia

Revmatologie s.r.o.

Brno, , Czechia

Nemocnice Jihlava p.o

Jihlava, , Czechia

MUDr. Gabriela Simkova ordinace lekare specialisty interna revmatologie

Kladno, , Czechia

CTCenter MaVe s.r.o.

Olomouc, , Czechia

Vesalion s.r.o.

Ostrava, , Czechia

Artroscan s.r.o.

Ostrava - Trebovice, , Czechia

ARTHROHELP s.r.o.

Pardubice, , Czechia

CCR Pardubice

Pardubice, , Czechia

Clintrial, s.r.o.

Prague, , Czechia

Revmatologicky ustav

Prague, , Czechia

CCR Prague s.r.o.

Prague, , Czechia

MUDR. Zuzana Urbanova Revmatologie

Prague, , Czechia

Affidea Praha, s.r.o.

Prague, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

MUDR. Zuzana URBANOVA Revmatologie

Praha 4 Nusle, , Czechia

MEDICAL PLUS s.r.o.

Uherské Hradiště, , Czechia

PV Medical Services s.r.o.

Zlín, , Czechia

East Tallinn Central Hospital

Tallinn, , Estonia

Medita Kliinik OÜ

Tartu, , Estonia

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, Germany

SMO.MD GmbH

Magdeburg, Saxony-Anhalt, Germany

Rheumapraxis Dr. med. Reiner Kurthen

Aachen, Westfalen, Germany

Klinische Forschung Berlin-Mitte GmbH

Berlin, , Germany

HRF Hamburger Rheuma Forschungszentrum

Hamburg, , Germany

Studienambulanz Dr. Wassenberg

Northeim, , Germany

Principal SMO Kft.

Baja, , Hungary

DRC Gyogyszervizsgalo Kozpont Kft.

Balatonfüred, , Hungary

Clinexpert Egeszsegugyi Szolg. es Ker. Kft.

Budapest, , Hungary

Obudai Egeszsegugyi Centrum

Budapest, , Hungary

Kiskunhalasi Semmelweis Korhaz

Kiskunhalas, , Hungary

DRC Szekesfehervar

Székesfehérvár, , Hungary

MAV Korhaz és Rendelointezet

Szolnok, , Hungary

Vital Medical Center

Veszprém, , Hungary

Dr.Saulite-Kandevica Private Practice

Liepāja, , Latvia

Alytаus Regional S. Kudirkos Hospital, Public Institution

Alytus, , Lithuania

Republican Kaunas Hospital, Public Institution

Kaunas, , Lithuania

Klaipeda University Hospital, Public Institution

Klaipėda, , Lithuania

Siauliai Republican Hospital, Public Institution

Šiauliai, , Lithuania

Center Outpatient Clinic, Public Institution

Vilnius, , Lithuania

Vilnius University Hospital Santariskiu Clinic, Public Institution

Vilnius, , Lithuania

Centro de Investigacion Clínica GRAMEL S.C

México, DisMexicotrito Federal, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, Mexico

Centro de Estudios de Investigacion Basica y Clinica SC

Guadalajara, Jalisco, Mexico

Clinstile, S.A. de C.V.

Mexico City, Mexico City, Mexico

Clinicos Asociados BOCM S.C.

Mexico City, Mexico City, Mexico

Cryptex Investigacion Clinica S.C

Mexico City, Mexico City, Mexico

Accelerium S. de R.L. de C.V.

Monterrey, Nuevo León, Mexico

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

Monterrey, Nuevo León, Mexico

Clinical Research Institute S.C.

México, State of Mexico, Mexico

Investigacion y Biomedicina de Chihuahua, S.C.

Chihuahua City, , Mexico

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

San Luis Potosí City, , Mexico

NZOZ ZDROWIE Osteo-Medic

Bialystok, , Poland

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, , Poland

MCBK Iwona Czajkowska Anna PodrażkaSzczepaniak S.C.

Grodzisk Mazowiecki, , Poland

Polimedica Centrum Badań, Profilaktyki I Leczenia

Kielce, , Poland

Centrum Medyczne AMED

Lodz, , Poland

ETYKA Osrodek Badan Klinicznych

Olsztyn, , Poland

Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego

Sieradz, , Poland

CCBR - Lodz - PL

Skierniewice, , Poland

Clinmed Research

Skierniewice, , Poland

RCMed

Sochaczew, , Poland

KO-MED Centra Kliniczne Staszow

Staszów, , Poland

Samodzielny Publiczny ZOZ Tomaszow Lubelski

Tomaszów Lubelski, , Poland

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

Torun, , Poland

Medycyna Kliniczna

Warsaw, , Poland

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, , Poland

McM Polimedica

Warsaw, , Poland

KO-MED Centra Kliniczne Zamosc

Zamość, , Poland

Santa Familia Centrum Badan, Profilaktyki i Leczenia

Zgierz, , Poland

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

Constanța, , Romania

Hospital n a Kuvatov

Ufa, Bashkortostan Republic, Russia

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

Saint Petersburg, Leningradskaya Oblast', Russia

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

Moscow, Moscovskaya Oblast, Russia

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

Moscow, Moscow Oblast, Russia

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

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

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

Petrozavodsk, Republic of Karelia, Russia

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

Smolensk, Smolensk Oblast, Russia

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

Yekaterinburg, Sverdlovsk Oblast, Russia

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

Yekaterinburg, Sverdlovsk Oblast, Russia

Institute n a Nasonova

Moscow, , Russia

Eulji University Hospital

Daejeon, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

CHA Bundang Medical Center

Gyeonggi-do, , South Korea

Jeju National University Hospital

Jeju City, , South Korea

Severance Hospital, Yonsei University

Seoul, , South Korea

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

Seoul, , South Korea

Chi Mei Medical Center

Tainan City, , Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan District, , Taiwan

Torbay Hospital

Torquay, Devon, United Kingdom

Whipps Cross University Hospital

London, Greater London, United Kingdom

Royal Free Hospital

London, Greater London, United Kingdom

Basingstoke and North Hampshire Hospital

Basingstoke, Hampshire, United Kingdom

Maidstone Hospital

Maidstone, Kent, United Kingdom

Arrowe Park Hospital

Metropolitan Borough of Wirral, Merseyside, United Kingdom

Countries

United States; Argentina; Brazil; Bulgaria; Colombia; Czechia; Estonia; Germany; Hungary; Latvia; Lithuania; Mexico; Poland; Romania; Russia; South Korea; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36001712 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CL04041023

Identifier Type: -

Identifier Source: org_study_id