AzTrials
AzTrials

Rheumatoid ArthritisPhase 3CREDO 4NCT03120949

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

A Phase 3 study testing Olokizumab 64 mg SC q4w, Olokizumab 64 mg SC q2w and Concomitant treatment in people with Rheumatoid Arthritis, run by R-Pharm International, LLC at 239 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Olokizumab 64 mg SC q4w, Olokizumab 64 mg SC q2w and Concomitant treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,106 participants
Where
239 sitesin 18 countries
Study dates
4 Jul 2017to 1 Sep 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects 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.

Who cannot join

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

Trial locations and contacts

239 sites in 18 countries.

239 sites in 18 countries

United States71 sites

  • Lovelace Scientific Resources, Inc.

    Albuquerque, New Mexico, 87114

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Austin Regional Clinic, P.A.

    Austin, Texas, 78731

  • Accurate Clinical Management., LLC

    Baytown, Texas, 77521

  • RASF - Clinical Research Center

    Boca Raton, Florida, 33486

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • New England Research Associates LLC

    Bridgeport, Connecticut, 06606

  • NYU Langone ambulatory care

    Brooklyn, New York, 11201

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio, 45242

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • Medvin Clinical Research

    Covina, California, 91722

  • Pioneer Research Solutions, Inc.

    Cypress, Texas, 77429

  • STAT Research, Inc.

    Dayton, Ohio, 45417

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Altoona Center for Clinical Research, P.C.

    Duncansville, Pennsylvania, 16635

  • Arthritis & Osteoporosis Associates, PA

    Freehold, New Jersey, 07728

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • AA MRC LLC Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • Klein and Associates, M.D., P.A.

    Hagerstown, Maryland, 21740

  • C.V Mehta MD Med Corp..

    Hemet, California, 92543

  • Reliable Clinical Research, LLC

    Hialeah, Florida, 33012

  • CHI St. Vincent Hot Springs

    Hot Springs, Arkansas, 71913

  • Therapeutic Concepts Rheumatology,LLC

    Houston, Texas, 77004

  • Rheumatology Clinic of Houston, P.A.

    Houston, Texas, 77065

  • Houston Institute For Clinical Research

    Houston, Texas, 77074

  • Accurate Clinical Mangemnt - Partner

    Houston, Texas, 77089

  • Accurate Clinical Research, Inc.

    Houston, Texas, 77089

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • Glacier View Research Institute-Rheumatology

    Kalispell, Montana, 59901

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Advanced Medical Research, LLC

    La Palma, California, 90623

  • Accurate Clinical Research, Inc.

    League City, Texas, 77573

  • Cape Fear Arthritis Care

    Leland, North Carolina, 28451

  • Physician Research Collaboration

    Lincoln, Nebraska, 68516

  • Valerius Medical Group

    Los Alamitos, California, 90720-5403

  • West Texas Clinical Research

    Lubbock, Texas, 79410

  • Marietta Rheumatology Associates, PC

    Marietta, Georgia, 30060

  • AZ Arthritis & Rheum' Research

    Mesa, Arizona, 85210

  • Pharmax Research Clinic

    Miami, Florida, 33126

  • Medical Research Center of Miami

    Miami, Florida, 33134

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Trinity Medical Group

    Minot, North Dakota, 58701

  • The Arthritis & Diabetes Clinic, Inc.

    Monroe, Louisiana, 71203

  • Javed Rheumatology Associates

    Newark, Delaware, 19713

  • Health Research of Oklahoma, PLLC

    Oklahoma City, Oklahoma, 73103

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Omega Research Consultants

    Orlando, Florida, 32810

  • Arthritis Research of Florida, INC

    Palm Harbor, Florida, 34684

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • Family Clinical Trials, LLC.

    Pembroke Pines, Florida, 33026

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona, 85032

  • Dr Alex De Jesus Rheumatology, P.A.

    San Antonio, Texas, 78229

  • Rheumatology Center of San Diego

    San Diego, California, 92128

  • East Bay Rheumatology Medical Group, Inc.

    San Leandro, California, 94578

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • Low Country Rheumatology, PA

    Summerville, South Carolina, 29486

  • Arizona Arthritis & Rheumatology Research, PLLC

    Sun City, Arizona, 85351

  • AdventHealth Medical Group, PA

    Tampa, Florida, 33614

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382

  • Clinical Research Source, Inc.

    Toledo, Ohio, 43606

  • DM Clinical Research

    Tomball, Texas, 77375

  • North MS Medical Clinics, Inc.

    Tupelo, Mississippi, 38801

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

  • Lovelace Scientific Resources, Inc.

    Venice, Florida, 34292

  • Center for Rheumatology Research, Comprehensive Rheumatology Center

    West Hills, California, 91307

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Medvin Clinical Research

    Whittier, California, 90602

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

Other trials in United States

Russia34 sites

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

    Barnaul, Altayskiy Kray, 656038

  • 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

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

    Kemerovo, Kemerovo Oblast, 650000

  • Medical Center LLC "Maksimum Zdoroviya"

    Kemerovo, Kemerovo Oblast, 650066

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

    Kursk, Kursk Oblast, 305007

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

    Moscow, Moscovskaya Oblast, 119049

  • 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

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

    Moscow, Moscovskaya Oblast, 119991

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

    Moscow, Moscow Oblast, 111539

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

    Moscow, Moscow Oblast, 115093

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

    Moscow, 115522

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

    Moscow, 119991

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

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603005

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

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126

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

    Novosibirsk, Novosibirsk Oblast, 630005

  • LLC "Clinical Diagnostic Center "Ultramed"

    Omsk, Omsk Oblast, 644024

  • Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"

    Omsk, Omsk Oblast, 644111

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

    Petrozavodsk, Republic of Karelia, 185019

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

    Rostov-on-Don, Rostov Oblast, 344022

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

    Ryazan, Ryazan Oblast, 390026

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

    Saint Petersburg, Leningradskaya Oblast', 190068

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

    Saint Petersburg, 197341

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

    Saratov, Saratov Oblast, 410012

  • State Healthcare Institution "Regional Clinical Hospital"

    Saratov, Saratov Oblast, 410053

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

    Smolensk, Smolensk Oblast, 214025

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

    Stavropol, Stavropol Kray, 355030

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

    Tula, Tulskaya Oblast, 300053

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

    Ufa, Respublic of Bashkortostan, 450005

  • State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"

    Ulyanovsk, Ulyanovsk Oblast, 432063

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

    Vladimir, Vladimirskaya Oblast’, 600023

  • SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department

    Yaroslavl, Yaroslavl Oblast, 150062

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

    Yaroslavl, Yaroslavsakaya Oblast, 150003

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

    Yekaterinburg, Sverdlovsk Oblast, 620102

  • 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

Other trials in Russia

Czechia19 sites

  • CCR Brno s.r.o

    Brno, 602 00

  • IMEDICA s.r.o.

    Brno, 602 00

  • Revmatologie s.r.o.

    Brno, 638 00

  • Nemocnice Jihlava p.o.

    Jihlava, 586 01

  • MUDr Gabriela Simkova Ordinace Lekare Specialisty Interna Revmatologie

    Kladno, 272 01

  • CTCenter MaVe s.r.o.

    Olomouc, 77900

  • Vesalion s.r.o.

    Ostrava, 70200

  • ARTROSCAN s.r.o.

    Ostrava - Trebovice, 722 00

  • ARTHROHELP s.r.o.

    Pardubice, 530 02

  • CCR Czech, a.s.

    Pardubice, 530 02

  • CLINTRIAL s.r.o.

    Prague, 110 00

  • Revmatologicky ustav

    Prague, 128 00

  • CCR Prague s.r.o.

    Prague, 130 00

  • MUDR Zuzana URBANOVA Revmatologie

    Prague, 140 00

  • Affidea Praha s.r.o.

    Prague, 148 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • MUDR Zuzana URBANOVA Revmatologie

    Praha 4 Nusle, 140 00

  • Medical Plus s.r.o.

    Uherské Hradiště, 686 01

  • PV - MEDICAL, s.r.o.

    Zlín, 760 01

Other trials in Czechia

Poland19 sites

  • CERMED

    Bialystok, 15-270

  • ZDROWIE Osteo-Medic

    Bialystok, 15-351

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 85-168

  • MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.

    Grodzisk Mazowiecki, 05-825

  • Polimedica Centrum Badań, Profilaktyki I Leczenia

    Kielce, 25-355

  • CCBR - Lodz - PL

    Lodz, 90-368

  • Centrum Medyczne AMED

    Lodz, 91-363

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117

  • Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego

    Sieradz, 98-200

  • Clinmed Research

    Skierniewice, 96-100

  • RCMed

    Sochaczew, 96-500

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28-200

  • Samodzielny Publiczny ZOZ Tomaszow Lubelski

    Tomaszów Lubelski, 22-600

  • Nasz lekarz Przychodnie Medyczne

    Torun, 87-100

  • Medycyna Kliniczna

    Warsaw, 00-874

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warsaw, 02-118

  • McM Polimedica

    Warsaw, 02-777

  • KO-MED Centra Kliniczne Zamosc

    Zamość, 22-400

  • Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Zgierz, 95-100

Other trials in Poland

Argentina14 sites

  • Instituto de Investigaciones Clinicas-Mar del Plata

    Buenos Aires, B7600FZN

  • Organizacion Medica de Investigacion (OMI)

    Ciudad Autonoma Buenos Aires, C1015ABO

  • APRILLUS Asistencia e Investigacion

    Ciudad Autonoma Buenos Aires, C1046AAQ

  • Instituto Centenario

    Ciudad Autonoma Buenos Aires, C1204AAD

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, 5016

  • Instituto DAMIC Fundacion Rusculleda

    Córdoba, X5003DCE

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FYK

  • Instituto Medico CER

    Quilmes, Buenos Aires, B1878DVB

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

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

    San Juan, 5400

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Centro de Investigaciones Reumatológicas

    San Miguel de Tucumán, T4000BRD

  • Clinica de Higado y Aparato Digestivo

    Santa Fe, S2000CFJ

  • Sanatorio San Martin

    Venado Tuerto, Santa Fe Province, S2600KUE

Other trials in Argentina

Brazil14 sites

  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.

    Curitiba, Paraná, 80030-110

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

    Fortaleza, Ceará, 60430-370

  • CIP - Centro Internacional de Pesquisa

    Goiânia, Goiás, 74110-120

  • Clínica de Neoplasias Litoral Ltda.

    Itajaí, Santa Catarina, 88301-215

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-010

  • Clinilive - Clínica do Idoso e Pesquisa Clínica

    Maringá, Paraná, 87013-250

  • LMK Serviços Médicos S/S Ltda

    Pôrto Alegre, Rio Grande do Sul, 90480-000

  • CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

    Rio de Janeiro, 20241-180

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Centro Multidisciplinar de Estudos Clínicos - CEMEC

    São Bernardo do Campo, São Paulo, 09715-090

  • CPCLIN - Centro de Pesquisas Clínicas Ltda.

    São Paulo, 01228-200

  • Associação de Assistência à Criança Deficiente - AACD

    São Paulo, 04032-060

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Bulgaria12 sites

  • DCC 'Sv. Pantaleymon' OOD

    Pleven, 5800

  • UMHAT Pulmed OOD

    Plovdiv, 4000

  • UMHAT "Kaspela", EOOD

    Plovdiv, 4001

  • MHAT - Ruse, AD

    Rousse, 7002

  • Medizinski Zentar-1-Sevlievo EOOD

    Sevlievo, 5400

  • MHAT - Shumen, AD

    Shumen, 9700

  • NMTH "Tsar Boris III"

    Sofia, 1233

  • MHAT "Lyulin", EAD

    Sofia, 1336

  • Medical Center "Excelsior", OOD

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • MC "Synexus - Sofia", EOOD

    Sofia, 1784

  • MDHAT 'Dr. Stefan Cherkezov', AD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Mexico11 sites

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000

  • Clinica de Investigacion en Reumatologia y Obesidad S.C.

    Guadalajara, Jalisco, 44650

  • Centro de Estudios de Investigacion Basica y Clinica SC

    Guadalajara, Jalisco, 44690

  • Clinicos Asociados BOCM S.C.

    Mexico City, Mexico City, 3300

  • Centro de Investigacion Clínica GRAMEL S.C

    Mexico City, Mexico City, 3720

  • Comite Mexicano Para la Prevencion de Osteoporosis AC

    Mexico City, Mexico City, 6100

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 6700

  • Clinical Research Institute S.C.

    Mexico City, 54055

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

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

    Monterrey, Nuevo León, 64460

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

    San Luis Potosí City, 78213

Other trials in Mexico

Hungary8 sites

  • Principal SMO Kft.

    Baja, 6500

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, 8230

  • Clinexpert Kft.

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Kiskunhalasi Semmelweis Korhaz

    Kiskunhalas, 6400

  • DRC Szekesfehervar

    Székesfehérvár, 8000

  • MAV Korhaz es Rendelointezet

    Szolnok, 5000

  • Vital-Medicina Kft.

    Veszprém, 8200

Other trials in Hungary

South Korea7 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 431-796

  • Eulji University Hospital

    Daejeon, 35233

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Jeju National University Hospital

    Jeju City, 63241

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

    Seoul, 120-752

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

    Seoul, 6591

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 443-380

Other trials in South Korea

Germany6 sites

  • Rheumapraxis Dr. med. Reiner Kurthen

    Aachen, North Rhine-Westphalia, 52064

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, Hesse, 61231

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • HRF Hamburger Rheuma Forschungszentrum

    Hamburg, 20095

  • SMO.MD GmbH

    Magdeburg, Saxony-Anhalt, 39120

  • Studienambulanz Dr. Wassenberg

    Ratingen, North Rhine-Westphalia, 40878

Other trials in Germany

Lithuania6 sites

  • Alytus Regional S. Kudirkos Hospital, Public Institution

    Alytus, 62114

  • Republican Kaunas Hospital, Public Institution

    Kaunas, 45130

  • Klaipeda University Hospital, Public Institution

    Klaipėda, 92288

  • Siauliai Republican Hospital, Public Institution

    Šiauliai, 76231

  • Center Outpatient Clinic, Public Institution

    Vilnius, LT-01117

  • Vilnius University Hospital Santariskiu Clinics, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

United Kingdom6 sites

  • Basingstoke and North Hampshire Hospital

    Basingstoke, Hampshire, RG24 9NA

  • Whipps Cross University Hospital

    London, Greater London, E11 1NR

  • Royal Free Hospital

    London, Greater London, NW3 2QG

  • Maidstone Hospital

    Maidstone, Kent, ME16 9QQ

  • Arrowe Park Hospital

    Metropolitan Borough of Wirral, Merseyside, L49 5PE

  • Torbay Hospital

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Colombia5 sites

  • Centro de Reumatologia y Ortopedia SAS

    Barranquilla, 80020

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

    Bogotá, 110221

  • Fundacion Instituto de Reumatologia Fernando Chalem

    Bogotá, 111211

  • Medicity S.A.S.

    Bucaramanga, 680003

  • Clinica de Artritis Temprana S.A.S

    Cali, 76001

Other trials in Colombia

Belarus2 sites

  • Minsk City Clinical Hospital #1

    Minsk, Minsk Oblast, 220013

  • Vitebsk Clinical Hospital

    Vitebsk, Vitebsk Oblast, 210037

Other trials in Belarus

Estonia2 sites

  • East Tallinn Central Hospital

    Tallinn, 11312

  • Meditrials OU

    Tartu, 50708

Other trials in Estonia

Taiwan2 sites

  • Chi Mei Medical Center, Yung Kang Branch

    Tainan, 710

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

Other trials in Taiwan

Latvia1 site

  • Dr.Saulite-Kandevica Private Practice

    Liepāja, LV-3401

Other trials in Latvia

About this study

Official title: A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis

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.

Read the 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).

Being tested
Olokizumab 64 mg SC q4w, Olokizumab 64 mg SC q2w, Concomitant treatment
Keywords
Rheumatoid Arthritis, moderate, severe, subcutaneous, Olokizumab, open-label
Medical subject headings
Arthritis, Rheumatoid, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olokizumab 64 mg SC q4wDrug

    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.

  • Olokizumab 64 mg SC q2wDrug

    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 treatmentDrug

    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

Study groups in NCT03120949
Study groupRoleWhat they receive
Treatment Arm 1: OKZ 64 mg q4w + MTXExperimentalOlokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Receives: Drug: Olokizumab 64 mg SC q4w; Drug: Concomitant treatment
Treatment Arm 2: OKZ 64 mg q2w + MTXExperimentalOlokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Receives: Drug: Olokizumab 64 mg SC q2w; Drug: Concomitant treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to Week 126

  2. 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.

    Measured: up to Week 126

  3. Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)

    Measured: up to Week 126

  4. Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment

    Measured: up to Week 126

  5. 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.

    Measured: up to Week 126

  6. 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.

    Measured: up to Week 126

  7. 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.

    Measured: up to Week 126

Secondary outcomes (14)

  1. American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82

    Number and Proportion of subjects achieving an ACR20 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82.

    American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures:

    • Patient Global Assessment of Disease Activity (VAS)
    • Patient Assessment of Pain (VAS)
    • HAQ-DI
    • Physician Global Assessment (VAS)
    • Level of acute phase reactant (CRP)

    Measured: up to Week 82

  2. American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82

    Number and Proportion of subjects achieving an ACR50 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82

    American College of Rheumatology 50 % response is a composite defined as a ≥ 50% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures:

    • Patient Global Assessment of Disease Activity (VAS)
    • Patient Assessment of Pain (VAS)
    • HAQ-DI
    • Physician Global Assessment (VAS)
    • Level of acute phase reactant (CRP)

    Measured: up to Week 82

  3. American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82

    Number and Proportion of subjects achieving an ACR70 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82

    American College of Rheumatology 70 % response is a composite defined as a ≥ 70% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 70% improvement from baseline in at least 3 of the 5 remaining core set measures:

    • Patient Global Assessment of Disease Activity (VAS)
    • Patient Assessment of Pain (VAS)
    • HAQ-DI
    • Physician Global Assessment (VAS)
    • Level of acute phase reactant (CRP)

    Measured: up to Week 82

  4. Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82

    The number and proportion of subjects with SDAI score ≤ 3.3 (considered to be in remission).

    The SDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), CRP (mg/dL), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) + CRP (mg/dL)

    Measured: up to week 82

  5. Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82

    Number and Proportion of subjects with DAS28 low disease activity (based on DAS28 C-reactive protein (CRP) < 3.2), who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82.

    The DAS28 (CRP) was calculated in the statistical database for analysis purposes using the Swollen joint count (SJC) (28 joints), Tender joint count (TJC) (28 joints), CRP level, and the Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) (100 mm VAS, where 0 is "no disease activity" and 100 was "maximal disease activity") according to the following formula: [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.36 × natural log (CRP+1)] + [0.014 × VAS] + 0.96.

    Measured: up to Week 82

  6. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12

    HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

    The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.

    Measured: Core baseline, Week 12

  7. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20

    HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

    The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.

    Measured: Core baseline, Week 20

  8. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28

    HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

    The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.

    Measured: Core baseline, Week 28

  9. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40

    HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

    The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.

    Measured: Core baseline, Week 40

  10. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52

    HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

    The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.

    Measured: Core baseline, Week 52

  11. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64

    HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

    The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.

    Measured: Core baseline, Week 64

  12. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82

    HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

    The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.

    Measured: Core baseline, Week 82

  13. Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82

    The number and proportion of subjects with HAQ-DI improvement ≥ 0.22 Against OLE Baseline.

    HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

    The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.

    Measured: up to week 82

  14. Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)

    CDAI Range: 0 (the best outcome) - 76 (the worst outcome), with a decrease from baseline indicating improvement.

    The CDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: CDAI = SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS)

    Measured: up to week 82

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2017
  2. Study start4 Jul 2017
  3. Primary completion1 Sep 2021
  4. Study completion1 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03120949
Sponsor's protocol ID
CL04041024
Other IDs
2015-005309-35, 2015
Acronym
CREDO 4
Status last verified
Sep 2023
First submitted
7 Feb 2017
Last updated
12 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Fleischmann RM, Strand V, Feist E, Lisitsyna T, Sparks JA, Nasonov E, Samsonov M, Grishin S, Egorova A, Kuzkina S, Smolen JS. Olokizumab Improves Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis up to 106 Weeks (Results from the Open-Label Extension of Phase III Randomized Clinical Trials). Rheumatol Ther. 2026 Aug;13(4):1055-1074. doi: 10.1007/s40744-026-00852-3. Epub 2026 May 16.

    PubMed 42142212

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olokizumab 64 mg SC q4w, Olokizumab 64 mg SC q2w and Concomitant treatment in people with Rheumatoid Arthritis, run by R-Pharm International, LLC at 239 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 239 sites in United States, Russia, Czechia, Poland, Argentina and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) (time frame: up to Week 126). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03120949, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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