Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
CREDO 4
A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
2 other identifiers
interventional
2,106
18 countries
239
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.
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 Jul 2017
Longer than P75 for phase_3 rheumatoid-arthritis
239 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
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedStudy Start
First participant enrolled
July 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedResults Posted
Study results publicly available
June 7, 2022
CompletedOctober 12, 2023
September 1, 2023
4.2 years
February 7, 2017
April 14, 2022
September 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term
up to Week 126
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term. Deaths are included.
up to Week 126
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
up to Week 126
Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment
up to Week 126
Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure
Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
up to Week 126
Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure
Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
up to Week 126
Incidence Rate of Treatment Emergent AESIs (Safety Population)
Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
up to Week 126
Secondary Outcomes (14)
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
up to Week 82
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
up to Week 82
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
up to Week 82
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
up to week 82
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
up to Week 82
- +9 more secondary outcomes
Study Arms (2)
Treatment Arm 1: OKZ 64 mg q4w + MTX
EXPERIMENTALOlokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Treatment Arm 2: OKZ 64 mg q2w + MTX
EXPERIMENTALOlokizumab 64 mg SC q2w + 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 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.
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.
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
Eligibility Criteria
You may qualify if:
- Subjects may be enrolled in the study only if they meet all of the following criteria:
- Subject must be willing and able to sign informed consent
- Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL04041025).
- 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
- Subjects must be willing to take folic acid or equivalent throughout the study.
You may not qualify if:
- Subject has evidence of active tuberculosis (TB)
- 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:
- 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);
- 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
- The subject is willing to complete the entire course of recommended LTBI therapy.
- Subject has planned surgery during the first 12 weeks of the OLE study
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Pharm International, LLClead
- IQVIA Pvt. Ltdcollaborator
- OCT Clinical Trialscollaborator
Study Sites (239)
AZ Arthritis & Rheum' Research
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
CHI St. Vincent Hot Springs
Hot Springs, Arkansas, 71913, United States
Medvin Clinical Research
Covina, California, 91722, United States
C.V Mehta MD Med Corp..
Hemet, California, 92543, United States
Advanced Medical Research, LLC
La Palma, California, 90623, United States
Valerius Medical Group
Los Alamitos, California, 90720-5403, United States
Stanford University School of Medicine
Palo Alto, California, 94304, 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
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
Center for Rheumatology Research, Comprehensive Rheumatology Center
West Hills, California, 91307, 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, 06606, 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
Miami, Florida, 33126, United States
Medical Research Center of Miami
Miami, Florida, 33134, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Omega Research Consultants
Orlando, Florida, 32810, United States
Arthritis Research of Florida, INC
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
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
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, 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 Institute-Rheumatology
Kalispell, Montana, 59901, United States
Physician Research Collaboration
Lincoln, Nebraska, 68516, United States
Arthritis & Osteoporosis Associates, PA
Freehold, New Jersey, 07728, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87114, 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
Carolina Arthritis Associates
Wilmington, North Carolina, 28401, United States
Trinity Medical Group
Minot, North Dakota, 58701, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, 45242, 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
Arthritis Group
Philadelphia, Pennsylvania, 19152, 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
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
Pioneer Research Solutions, Inc.
Cypress, Texas, 77429, United States
Therapeutic Concepts Rheumatology,LLC
Houston, Texas, 77004, United States
Rheumatology Clinic of Houston, P.A.
Houston, Texas, 77065, United States
Houston Institute For Clinical Research
Houston, Texas, 77074, United States
Accurate Clinical Mangemnt - Partner
Houston, Texas, 77089, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77089, United States
Accurate Clinical Research, Inc.
League City, Texas, 77573, United States
West Texas Clinical Research
Lubbock, Texas, 79410, United States
Dr Alex De Jesus Rheumatology, P.A.
San Antonio, Texas, 78229, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, 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 Medico CER
Quilmes, Buenos Aires, B1878DVB, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, B1878GEG, Argentina
Sanatorio San Martin
Venado Tuerto, Santa Fe Province, S2600KUE, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Instituto de Investigaciones Clinicas-Mar del Plata
Buenos Aires, B7600FZN, 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
Córdoba, 5016, Argentina
Instituto DAMIC Fundacion Rusculleda
Córdoba, X5003DCE, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, 5400, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, T4000BRD, Argentina
Clinica de Higado y Aparato Digestivo
Santa Fe, S2000CFJ, Argentina
Minsk City Clinical Hospital #1
Minsk, Minsk Oblast, 220013, Belarus
Vitebsk Clinical Hospital
Vitebsk, Vitebsk Oblast, 210037, Belarus
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, 60430-370, Brazil
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, 29055-450, 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
Pôrto Alegre, Rio Grande do Sul, 90480-000, Brazil
Clínica de Neoplasias Litoral Ltda.
Itajaí, Santa Catarina, 88301-215, 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
CPCLIN - Centro de Pesquisas Clínicas Ltda.
São Paulo, 01228-200, Brazil
Associação de Assistência à Criança Deficiente - AACD
São Paulo, 04032-060, Brazil
DCC 'Sv. Pantaleymon' OOD
Pleven, 5800, Bulgaria
UMHAT Pulmed OOD
Plovdiv, 4000, Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv, 4001, 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 Reumatologia y Ortopedia SAS
Barranquilla, 80020, 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.S
Cali, 76001, Colombia
CCR Brno s.r.o
Brno, 602 00, Czechia
IMEDICA s.r.o.
Brno, 602 00, 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 Czech, a.s.
Pardubice, 530 02, Czechia
CLINTRIAL s.r.o.
Prague, 110 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, s.r.o.
Zlín, 760 01, Czechia
East Tallinn Central Hospital
Tallinn, 11312, Estonia
Meditrials OU
Tartu, 50708, Estonia
Kerckhoff-Klinik gGmbH
Bad Nauheim, Hesse, 61231, Germany
Rheumapraxis Dr. med. Reiner Kurthen
Aachen, North Rhine-Westphalia, 52064, Germany
Studienambulanz Dr. Wassenberg
Ratingen, North Rhine-Westphalia, 40878, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, 39120, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, 20095, Germany
Principal SMO Kft.
Baja, 6500, Hungary
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, 8230, Hungary
Clinexpert Kft.
Budapest, 1033, Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Kiskunhalasi Semmelweis Korhaz
Kiskunhalas, 6400, Hungary
DRC Szekesfehervar
Székesfehérvár, 8000, Hungary
MAV Korhaz es Rendelointezet
Szolnok, 5000, Hungary
Vital-Medicina Kft.
Veszprém, 8200, Hungary
Dr.Saulite-Kandevica Private Practice
Liepāja, LV-3401, Latvia
Alytus 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 Clinics, Public Institution
Vilnius, LT-08661, Lithuania
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
Clinicos Asociados BOCM S.C.
Mexico City, Mexico City, 3300, Mexico
Centro de Investigacion Clínica GRAMEL S.C
Mexico City, Mexico City, 3720, Mexico
Comite Mexicano Para la Prevencion de Osteoporosis AC
Mexico City, Mexico City, 6100, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, 6700, 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
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, 31000, Mexico
Clinical Research Institute S.C.
Mexico City, 54055, Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
San Luis Potosí City, 78213, Mexico
CERMED
Bialystok, 15-270, Poland
ZDROWIE Osteo-Medic
Bialystok, 15-351, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, 85-168, Poland
MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.
Grodzisk Mazowiecki, 05-825, Poland
Polimedica Centrum Badań, Profilaktyki I Leczenia
Kielce, 25-355, Poland
CCBR - Lodz - PL
Lodz, 90-368, 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
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
Nasz lekarz Przychodnie Medyczne
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
FSBEI HE "Altai State Medical University of the Ministry of Healthcare of Russian Federation"
Barnaul, Altayskiy Kray, 656038, Russia
SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"
Kemerovo, Kemerovo Oblast, 650000, Russia
Medical Center LLC "Maksimum Zdoroviya"
Kemerovo, Kemerovo Oblast, 650066, Russia
Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region
Kursk, Kursk Oblast, 305007, Russia
SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit
Saint Petersburg, Leningradskaya Oblast', 190068, Russia
SBHI of Moscow "City Clinical Hospital No.1 n.a. Pirogov" Healthcare Department of Moscow
Moscow, Moscovskaya Oblast, 119049, 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, 119435, Russia
FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"
Moscow, Moscovskaya Oblast, 119991, 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 Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament"
Moscow, Moscow Oblast, 115093, Russia
SBHI of Nizhegorodsky Region "State Clinical Hospital #5 of Nizhegorodsky District of Nizhny Novgorod"
Nizhny Novgorod, Nizhny Novgorod Oblast, 603005, Russia
SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia
State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1"
Novosibirsk, Novosibirsk Oblast, 630005, Russia
LLC "Clinical Diagnostic Center "Ultramed"
Omsk, Omsk Oblast, 644024, Russia
Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"
Omsk, Omsk Oblast, 644111, Russia
SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
Petrozavodsk, Republic of Karelia, 185019, Russia
State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov"
Ufa, Respublic of Bashkortostan, 450005, Russia
FSBEI HE "Rostov State Medical Unversity" of Ministry of Health of the Russian Federation
Rostov-on-Don, Rostov Oblast, 344022, Russia
FSBEI HE 'Ryazan State Medical University n.a. I.P.Pavlov" of the Ministry of Health of Russian Federation
Ryazan, Ryazan Oblast, 390026, Russia
FSBEI HE "Saratov SMU n.a. V.I.Razumovsky of Ministry of Health of Russian Federation"
Saratov, Saratov Oblast, 410012, Russia
State Healthcare Institution "Regional Clinical Hospital"
Saratov, Saratov Oblast, 410053, Russia
Private Healthcare Institution "Clinical Hospital Russian Railways-Medicine of City Smolensk"
Smolensk, Smolensk Oblast, 214025, Russia
FSBEI HE StSMU MOH Russia based on SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"
Stavropol, Stavropol Kray, 355030, Russia
State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
Yekaterinburg, Sverdlovsk Oblast, 620102, 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, 620149, 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, 420012, Russia
State Healthcare Institution of Tula region "Tula Regional Clinical Hospital"
Tula, Tulskaya Oblast, 300053, Russia
State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"
Ulyanovsk, Ulyanovsk Oblast, 432063, Russia
SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament
Vladimir, Vladimirskaya Oblast’, 600023, Russia
SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department
Yaroslavl, Yaroslavl Oblast, 150062, Russia
State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev"
Yaroslavl, Yaroslavsakaya Oblast, 150003, Russia
FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
Moscow, 115522, Russia
FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"
Moscow, 119991, Russia
FSBI "National Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, 197341, Russia
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 431-796, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 443-380, South Korea
Eulji University Hospital
Daejeon, 35233, South Korea
Chonnam National University Hospital
Gwangju, 501-757, South Korea
Jeju National University Hospital
Jeju City, 63241, South Korea
Severance Hospital, Yonsei University No. 31 Office, Pediatric Oncology Clinic
Seoul, 120-752, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591, South Korea
Chi Mei Medical Center, Yung Kang Branch
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, L49 5PE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sergey Grishin, Head of Scientific Affairs Department
- Organization
- R-Pharm
Study Officials
- STUDY DIRECTOR
Mikhail Samsonov
Chief Medical Officer, 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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2017
First Posted
April 19, 2017
Study Start
July 4, 2017
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
October 12, 2023
Results First Posted
June 7, 2022
Record last verified: 2023-09