Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis

NCT ID: NCT03120949

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-04
• Study Completion Date: 2021-09-01

Brief Summary

The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had completed 24 weeks of double-blind treatment in Study CREDO 1, 2 or 3 (core studies). The long-term efficacy, immunogenicity, the physical function and quality of life of subjects received long-term treatment with OKZ were assessed as well.

Detailed Description

This OLE study (CL04041024) included an 82-week open-label Treatment Period that followed completion of one of the core studies (Study CREDO 1, 2 or 3). The OLE open-label Treatment Period lasted from Visit 1 (OLE Baseline/Week 24) to Visit 10 (End of Treatment (EoT)/Week 106), followed by a 20-week Safety Follow-Up Period from Week 106 to Week 126. The first visit of the OLE study was the same visit as the Week 24 visit in the core studies.

Subjects were randomized to 1 of the 2 OKZ treatment groups in the OLE study based on the treatment received in the core studies. Subjects who had received OKZ (q2w or q4w) in the core study in which they had participated (including subjects who received placebo in Study CREDO 3 and were re-randomized to OKZ at Week 16) received the same OKZ treatment regimen in the OLE study. Subjects who had received placebo (Study CREDO 1 and CREDO 2) or adalimumab (Study CREDO 2) in the core study in which they had participated were randomized in a 1:1 ratio to OKZ 64 mg q2w or OKZ 64 mg q4w regimens in the OLE study.

For the first 12 weeks of the OLE, all subjects were required to remain on a stable dose of background methotrexate (MTX) at 15 to 25 mg/week (or≥10 mg/week if there was documented intolerance to higher doses) with a stable route of administration (oral, SC, or intramuscular (IM)). After 12 weeks (Visit 4 [Week 36] of the OLE study), the Investigator might adjust the MTX dosage and route, per local guidelines. Methotrexate might be adjusted only for safety reasons according to Investigator discretion before Visit 4 (Week 36) of the OLE study.

Subjects who had been on rescue disease-modifying anti-rheumatic drugs (DMARDs) during the core studies were asked to continue these medications for the first 12 weeks of the OLE study. The Investigator could adjust these background medications if deemed appropriate after Visit 4 (Week 36) of the OLE study. Background rescue therapy might be adjusted only for safety reasons according to Investigator discretion before Visit 4 (Week 36) of the OLE study.

Throughout the study, concomitant treatment with folic acid ≥ 5 mg per week or equivalent was required for all subjects.

Subjects returned to the study site periodically for safety and response assessments as per the Schedule of Events.

The last dose of open-label study treatment in the OLE study was administered at Week 104 for all subjects. After completion of the 82-week open-label Treatment Period, subjects entered the 20-week Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for 3 visits at +4, +8, and +22 weeks after the last dose of study treatment.

Subjects who discontinued the open-label treatment prematurely required to come for the EoT Visit 2 weeks after the last study treatment administration and then return for the 3 Safety Follow-Up Visits +4, +8, and +22 weeks after the last study treatment administration.

Adverse events were assessed throughout the study period and evaluated using the Common Technology Criteria version 4.0 (CTCAE v 4.0).

There were ongoing monitoring of safety events, including laboratory findings by the Sponsor or its designee. In addition, safety parameters were assessed throughout the study by an independent Data Safety Monitoring Board (DSMB).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm 1: OKZ 64 mg q4w + MTX

Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).

Group Type: EXPERIMENTAL

Olokizumab 64 mg SC q4w

Intervention Type: DRUG

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.

Concomitant treatment

Intervention Type: DRUG

Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.)

Folic acid ≥ 5 mg per week or equivalent

Treatment Arm 2: OKZ 64 mg q2w + MTX

Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).

Group Type: EXPERIMENTAL

Olokizumab 64 mg SC q2w

Intervention Type: DRUG

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.

Concomitant treatment

Intervention Type: DRUG

Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.)

Folic acid ≥ 5 mg per week or equivalent

Interventions

Olokizumab 64 mg SC q4w

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.

Intervention Type: DRUG

Olokizumab 64 mg SC q2w

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.

Intervention Type: DRUG

Concomitant treatment

Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.)

Folic acid ≥ 5 mg per week or equivalent

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects may be enrolled in the study only if they meet all of the following criteria:

1. Subject must be willing and able to sign informed consent

2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL04041025).

3. Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or ≥ 10 mg/week if there is documented intolerance to higher doses) during the core study and plan to maintain the same dose and route of administration for ≥ 12 additional weeks

4. Subjects must be willing to take folic acid or equivalent throughout the study.

Exclusion Criteria

1. Subject with any medically important condition in the core study (e.g., clinically significant laboratory values, frequent Adverse events (AEs) or serious adverse events (SAEs), infection SAEs, and/or other concurrent severe and/or uncontrolled medical condition) which would make this subject unsuitable for inclusion in the open-label extension (OLE) study in the Investigator's judgement.

2. Subject has evidence of active tuberculosis (TB)

3. Subject with a positive or repeated indeterminate interferon-gamma release assay (IGRA) result at Week 22 of the core study

• Subjects may be enrolled in the OLE study if they fulfill all 3 of the following criteria prior to the first dose of study treatment:

1. Active TB is ruled out by a certified TB specialist or pulmonologist who is familiar with diagnosing and treating TB (as acceptable per local practice);

2. The subject starts prophylaxis for latent TB infection (LTBI) according to country-specific/Centers for Disease Control and Prevention (CDC) guidelines (treatment with isoniazid for 6 months is not an appropriate prophylactic regime for this study and it should not be used); and

3. The subject is willing to complete the entire course of recommended LTBI therapy.

4. Subject has planned surgery during the first 12 weeks of the OLE study

5. Female subjects who are pregnant or who are planning to become pregnant during the study or within 6 months of the last dose of study drug

6. 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.

Highly effective contraception is defined as:

• Female sterilization surgery: hysterectomy, surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first dose of study treatment in the core study

• In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by documented follow-up hormone level assessment
• Total abstinence if it is the preferred and constant lifestyle of the subject. Thus, periodic abstinence such as ovulation, symptothermal, postovulation, calendar methods, and withdrawal are not acceptable methods of contraception.
• Male sterilization surgery: at least 6 months prior to the first dose of study treatment in the core study (with the appropriate postvasectomy documentation of the absence of sperm in the ejaculate). For female subjects, the vasectomized male should be the only partner.
• Placement of established intrauterine device (IUD): IUD copper or IUD with progesterone
• Barrier method (condom and intravaginal spermicide, cervical caps with spermicide, or diaphragm with spermicide) in combination with the following: established oral, injected, or implanted hormone methods of contraception or contraceptive patch.

7. Subject is unwilling or unable to follow the procedures outlined in the protocol.

8. Other medical or psychiatric conditions, or laboratory abnormalities that may increase the potential risk associated with study participation and administration of the study treatment, or that may affect study results interpretation and, as per Investigator's judgement, make the subject ineligible.

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

Sponsors

IQVIA Pvt. Ltd

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

Chief Medical Officer, R-Pharm

Locations

AZ Arthritis & Rheum' Research

Mesa, Arizona, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, United States

CHI St. Vincent Hot Springs

Hot Springs, Arkansas, United States

Medvin Clinical Research

Covina, California, United States

C.V Mehta MD Med Corp..

Hemet, California, United States

Advanced Medical Research, LLC

La Palma, California, United States

Valerius Medical Group

Los Alamitos, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

Rheumatology Center of San Diego

San Diego, California, United States

East Bay Rheumatology Medical Group, Inc.

San Leandro, California, United States

Inland Rheumatology Clinical Trials, Inc.

Upland, California, United States

Center for Rheumatology Research, Comprehensive Rheumatology Center

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

Miami, Florida, United States

Medical Research Center of Miami

Miami, Florida, United States

Suncoast Research Group, LLC

Miami, Florida, United States

Omega Research Consultants

Orlando, Florida, United States

Arthritis Research of Florida, INC

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

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

Clinical Pharmacology Study Group

Worcester, Massachusetts, 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 Institute-Rheumatology

Kalispell, Montana, United States

Physician Research Collaboration

Lincoln, Nebraska, United States

Arthritis & Osteoporosis Associates, PA

Freehold, New Jersey, United States

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 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

Carolina Arthritis Associates

Wilmington, North Carolina, United States

Trinity Medical Group

Minot, North Dakota, United States

Cincinnati Rheumatic Disease Study Group

Cincinnati, Ohio, 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

Arthritis Group

Philadelphia, 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

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Pioneer Research Solutions, Inc.

Cypress, Texas, United States

Therapeutic Concepts Rheumatology,LLC

Houston, Texas, United States

Rheumatology Clinic of Houston, P.A.

Houston, Texas, United States

Houston Institute For Clinical Research

Houston, Texas, United States

Accurate Clinical Mangemnt - Partner

Houston, Texas, United States

Accurate Clinical Research, Inc.

Houston, Texas, United States

Accurate Clinical Research, Inc.

League City, Texas, United States

West Texas Clinical Research

Lubbock, Texas, United States

Dr Alex De Jesus Rheumatology, P.A.

San Antonio, Texas, United States

Advanced Rheumatology of Houston

The Woodlands, 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 Medico CER

Quilmes, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

Sanatorio San Martin

Venado Tuerto, Santa Fe Province, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Instituto de Investigaciones Clinicas-Mar del Plata

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

Córdoba, , Argentina

Instituto DAMIC Fundacion Rusculleda

Córdoba, , Argentina

CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

San Juan, , Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, , Argentina

Clinica de Higado y Aparato Digestivo

Santa Fe, , Argentina

Minsk City Clinical Hospital #1

Minsk, Minsk Oblast, Belarus

Vitebsk Clinical Hospital

Vitebsk, Vitebsk Oblast, Belarus

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

Pôrto Alegre, Rio Grande do Sul, Brazil

Clínica de Neoplasias Litoral Ltda.

Itajaí, Santa Catarina, 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

CPCLIN - Centro de Pesquisas Clínicas Ltda.

São Paulo, , Brazil

Associação de Assistência à Criança Deficiente - AACD

São Paulo, , Brazil

DCC 'Sv. Pantaleymon' OOD

Pleven, , Bulgaria

UMHAT Pulmed OOD

Plovdiv, , Bulgaria

UMHAT "Kaspela", EOOD

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 Reumatologia y Ortopedia SAS

Barranquilla, , 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.S

Cali, , Colombia

CCR Brno s.r.o

Brno, , Czechia

IMEDICA 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 Czech, a.s.

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, s.r.o.

Zlín, , Czechia

East Tallinn Central Hospital

Tallinn, , Estonia

Meditrials OU

Tartu, , Estonia

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, Germany

Rheumapraxis Dr. med. Reiner Kurthen

Aachen, North Rhine-Westphalia, Germany

Studienambulanz Dr. Wassenberg

Ratingen, North Rhine-Westphalia, Germany

SMO.MD GmbH

Magdeburg, Saxony-Anhalt, Germany

Klinische Forschung Berlin-Mitte GmbH

Berlin, , Germany

HRF Hamburger Rheuma Forschungszentrum

Hamburg, , Germany

Principal SMO Kft.

Baja, , Hungary

DRC Gyogyszervizsgalo Kozpont Kft.

Balatonfüred, , Hungary

Clinexpert Kft.

Budapest, , Hungary

Obudai Egeszsegugyi Centrum Kft.

Budapest, , Hungary

Kiskunhalasi Semmelweis Korhaz

Kiskunhalas, , Hungary

DRC Szekesfehervar

Székesfehérvár, , Hungary

MAV Korhaz es Rendelointezet

Szolnok, , Hungary

Vital-Medicina Kft.

Veszprém, , Hungary

Dr.Saulite-Kandevica Private Practice

Liepāja, , Latvia

Alytus 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 Clinics, Public Institution

Vilnius, , Lithuania

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, Mexico

Centro de Estudios de Investigacion Basica y Clinica SC

Guadalajara, Jalisco, Mexico

Clinicos Asociados BOCM S.C.

Mexico City, Mexico City, Mexico

Centro de Investigacion Clínica GRAMEL S.C

Mexico City, Mexico City, Mexico

Comite Mexicano Para la Prevencion de Osteoporosis AC

Mexico City, Mexico City, Mexico

Clinstile, S.A. de C.V.

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

Investigacion y Biomedicina de Chihuahua, S.C.

Chihuahua City, , Mexico

Clinical Research Institute S.C.

Mexico City, , Mexico

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

San Luis Potosí City, , Mexico

CERMED

Bialystok, , Poland

ZDROWIE Osteo-Medic

Bialystok, , Poland

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, , Poland

MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.

Grodzisk Mazowiecki, , Poland

Polimedica Centrum Badań, Profilaktyki I Leczenia

Kielce, , Poland

CCBR - Lodz - PL

Lodz, , Poland

Centrum Medyczne AMED

Lodz, , Poland

ETYKA Osrodek Badan Klinicznych

Olsztyn, , Poland

Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego

Sieradz, , Poland

Clinmed Research

Skierniewice, , Poland

RCMed

Sochaczew, , Poland

KO-MED Centra Kliniczne Staszow

Staszów, , Poland

Samodzielny Publiczny ZOZ Tomaszow Lubelski

Tomaszów Lubelski, , Poland

Nasz lekarz Przychodnie Medyczne

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

FSBEI HE "Altai State Medical University of the Ministry of Healthcare of Russian Federation"

Barnaul, Altayskiy Kray, Russia

SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"

Kemerovo, Kemerovo Oblast, Russia

Medical Center LLC "Maksimum Zdoroviya"

Kemerovo, Kemerovo Oblast, Russia

Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region

Kursk, Kursk Oblast, Russia

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

Saint Petersburg, Leningradskaya Oblast', Russia

SBHI of Moscow "City Clinical Hospital No.1 n.a. Pirogov" Healthcare Department of Moscow

Moscow, Moscovskaya Oblast, Russia

FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation" University Clinical Hospital No.1

Moscow, Moscovskaya Oblast, Russia

FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"

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 Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament"

Moscow, Moscow Oblast, Russia

SBHI of Nizhegorodsky Region "State Clinical Hospital #5 of Nizhegorodsky District of Nizhny Novgorod"

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

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

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1"

Novosibirsk, Novosibirsk Oblast, Russia

LLC "Clinical Diagnostic Center "Ultramed"

Omsk, Omsk Oblast, Russia

Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"

Omsk, Omsk Oblast, Russia

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

Petrozavodsk, Republic of Karelia, Russia

State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov"

Ufa, Respublic of Bashkortostan, Russia

FSBEI HE "Rostov State Medical Unversity" of Ministry of Health of the Russian Federation

Rostov-on-Don, Rostov Oblast, Russia

FSBEI HE 'Ryazan State Medical University n.a. I.P.Pavlov" of the Ministry of Health of Russian Federation

Ryazan, Ryazan Oblast, Russia

FSBEI HE "Saratov SMU n.a. V.I.Razumovsky of Ministry of Health of Russian Federation"

Saratov, Saratov Oblast, Russia

State Healthcare Institution "Regional Clinical Hospital"

Saratov, Saratov Oblast, Russia

Private Healthcare Institution "Clinical Hospital Russian Railways-Medicine of City Smolensk"

Smolensk, Smolensk Oblast, Russia

FSBEI HE StSMU MOH Russia based on SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"

Stavropol, Stavropol Kray, Russia

State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"

Yekaterinburg, Sverdlovsk Oblast, Russia

FSBEI HE "Ural State Medical University" of Ministry of Health of Russian Federation based on MBI "Central City Clinical Hospital No.6"

Yekaterinburg, Sverdlovsk Oblast, Russia

FSBEI HE "Kazan State Medical University of the Ministry of Health of the Russian Federation" on the base of SAHI "Republican Clinical Hospital of the Ministry of Health of Tatarstan Republic"

Kazan', The Republic of Tatarstan, Russia

State Healthcare Institution of Tula region "Tula Regional Clinical Hospital"

Tula, Tulskaya Oblast, Russia

State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"

Ulyanovsk, Ulyanovsk Oblast, Russia

SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament

Vladimir, Vladimirskaya Oblast’, Russia

SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department

Yaroslavl, Yaroslavl Oblast, Russia

State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev"

Yaroslavl, Yaroslavsakaya Oblast, Russia

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

Moscow, , Russia

FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"

Moscow, , Russia

FSBI "National Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation

Saint Petersburg, , Russia

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Eulji University Hospital

Daejeon, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Jeju National University Hospital

Jeju City, , South Korea

Severance Hospital, Yonsei University No. 31 Office, Pediatric Oncology Clinic

Seoul, , South Korea

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

Seoul, , South Korea

Chi Mei Medical Center, Yung Kang Branch

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

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-005309-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CL04041024

Identifier Type: -

Identifier Source: org_study_id