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Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease (CREDO 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02760433
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : December 3, 2018
Quintiles, Inc.
OCT Clinical Trials
Mene Research
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine how safe and effective the study drug Olokizumab is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully responding to treatment with an existing medication called a tumour necrosis factor alpha inhibitor

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Olokizumab q4w Drug: Olokizumab q2w Drug: Placebo q2w Phase 3

Detailed Description:
The goal of this Phase III study is to assess the safety, tolerability, and efficacy of OKZ in subjects with moderately to severely active RA who have responded inadequately to TNFi therapy. The primary endpoint of the trial is at Week 12. Olokizumab is expected to reduce the disease activity and improve physical function. The study is expected to provide safety information in a large group of subjects over at least a 24 week period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-α) Inhibitor Therapy
Study Start Date : December 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1: Olokizumab q4w + Methotrexate
Olokizumab 64 mg Subcutaneous q4w + Methotrexate (oral)
Drug: Olokizumab q4w
Experimental: Arm 2: Olokizumab q2w + Methotrexate
Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)
Drug: Olokizumab q2w
Placebo Comparator: Arm 3: Placebo q2w + Methotrexate
Placebo Subcutaneous q2w + Methotrexate (oral)
Drug: Placebo q2w

Primary Outcome Measures :
  1. ACR20 response [ Time Frame: at Week 12 ]
    A responder is defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12. This endpoint will serve to demonstrate that the efficacy of OKZ is superior to placebo.

Secondary Outcome Measures :
  1. Difference between OKZ and placebo in the percentage of subjects achieving low disease activity [ Time Frame: at Week 12 ]
    Defined as DAS28 (CRP) <3.2, and remaining on randomized treatment and in the study at Week 12.

  2. Difference between OKZ and placebo in the improvement of physical ability [ Time Frame: at Week 12 ]
    As measured by the Health Assessment Questionnaire Disability Index (HAQ DI)

  3. ACR50 response [ Time Frame: at Week 12 ]
    Difference between OKZ and placebo in the percentage of subjects achieving an ACR50 response and remaining on randomized treatment and in the study at Week 12.

  4. Simplified Disease Activity Index (SDAI) ≤3.3 (remission) [ Time Frame: at Week 12 ]
    Difference between OKZ and placebo in the percentage of subjects with Simplified Disease Activity Index (SDAI) ≤3.3 (remission) and remaining on randomized treatment and in the study at Week 12.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

  • Subjects willing and able to sign informed consent
  • Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 24 weeks prior to Screening.
  • Treatment with MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses)

    • The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening.
  • Subjects must be willing to take folic acid or equivalent throughout the study.
  • Subjects must have moderately to severely active RA disease as defined by all of the following:

    • ≥6 tender joints (68 joint count) at Screening and baseline; and
    • ≥6 swollen joints (66 joint count) at Screening and baseline; and
    • CRP above ULN at Screening based on the central laboratory results.
  • Subjects must have a documented inadequate response to treatment (i.e., TNFi failure) with ≥1 licensed TNFi following at least 12 weeks of therapy with that agent.

Exclusion Criteria:

  • Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus)
  • Prior exposure to any licensed or investigational compound directly or indirectly targeting IL 6 or IL 6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase [SYK] inhibitors)
  • Prior treatment with cell depleting therapies including anti CD20 or investigational agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19) with the exception of rituximab, which is allowed if it was discontinued at least 24 weeks prior to baseline (rituximab should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA).
  • Prior use of bDMARDs, within the following windows prior to baseline (bDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):

    1. 4 weeks for etanercept and anakinra
    2. 8 weeks for infliximab
    3. 10 weeks for adalimumab, certolizumab, and golimumab
    4. 12 weeks for abatacept
  • Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline
  • Prior history of no response to hydroxychloroquine and sulfasalazine
  • Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):

    1. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline
    2. 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours
    3. 24 weeks for cyclophosphamide
  • Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline
  • Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline
  • Use of non steroidal anti inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline
  • Previous participation in this study (randomized) or another study of OKZ
  • Abnormal laboratory values
  • Subjects with concurrent acute or chronic viral Hepatitis B or C infection
  • Subjects with HIV infection
  • Subjects with:

    1. Current active TB disease or a history of active TB disease.
    2. Close contact with an individual with active TB within 1.5yrs prior to Screening
    3. History of untreated latent TB infection (LTBI), regardless of IGRA result at Screening
    4. Positive interferon-gamma release assay (IGRA) result at Screening. If indeterminate, the IGRA can be repeated once during the Screening Period. If there is a second indeterminate result, the subject will be excluded.
  • Concurrent malignancy or a history of malignancy within the last 5 years
  • History of chronic alcohol or drug abuse as judged by the Investigator
  • Female subjects who are pregnant, currently lactating,
  • Female subjects of childbearing who are not willing to use a highly effective method of contraception during the study OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study.
  • Subjects with a known hypersensitivity to any component of the OKZ drug product or placebo
  • Other exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02760433

  Hide Study Locations
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United States, Alabama
Rheumatology Associates Of North Alabama- RANA Withdrawn
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Arthritis & Rheumatology Associates, P.C. Recruiting
Glendale, Arizona, United States, 85304
Contact: Saima Chohan    480-443-8400   
Contact: Anna Bermudez    480-626-6657   
Principal Investigator: Saima Chohan         
United States, Arkansas
CHI St. Vincent Hot Springs Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Ratinder Kaur    501-627-1800   
Contact: Jonathan Wright    501-520-5476 ext 128   
Principal Investigator: Ratinder Kaur         
Little Rock Diagnostic Clinic, PA Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Medvin Clinical Research Recruiting
Covina, California, United States, 91722
Contact: Samy Metyas    626-869-5730   
Contact: Ruby Espinosa    626-869-5730   
Principal Investigator: Samy Metyas         
TriWest Research Associates, LLC Recruiting
El Cajon, California, United States, 92020-4124
Contact: Arthur Mabaquiao    619-334-4735   
Contact: Lizenia Hernandez    619-334-4735   
Principal Investigator: Arthur Mabaquiao         
Saint Jude Heritage Medical Grp Withdrawn
Fullerton, California, United States, 92835
MD Med Corp. Recruiting
Hemet, California, United States, 92543
Contact: Chandrakant Mehta    951-652-5000   
Contact: Linda Stallman    951-652-5000   
Principal Investigator: Chandrakant Mehta         
Advanced Medical Research, LLC Recruiting
Lakewood, California, United States, 90712
Contact: Ho Gerald    562-867-8195   
Contact: Ray Beshai    562-867-8195   
Principal Investigator: Gerald Ho         
Riverside Medical Clinic Recruiting
Riverside, California, United States, 92506
Contact: Andre Babajanians    951-321-6473   
Contact: Eryka Sarzotti    951-321-6473   
Principal Investigator: Andre Babajanians         
East Bay Rheumatology Medical Group, Inc. Recruiting
San Leandro, California, United States, 94578
Contact: Clark Neuwelt    510-357-1303   
Contact: Shannon Radillo    510-357-1040   
Principal Investigator: Clark Neuwelt         
Orrin M Troum and Medical Associates Withdrawn
Santa Monica, California, United States, 90404
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305-2200
Contact: Mark Genovese    650-498-4528   
Contact: Rosario Villacorta    650-723-8516   
Principal Investigator: Mark Genovese         
Inland Rheumatology Clinical Trials, Inc. Recruiting
Upland, California, United States, 91786
Contact: Eric Lee    909-296-8700   
Contact: Amalia Ellis    909-296-8754   
Principal Investigator: Eric Lee         
Medvin Clinical Research Withdrawn
Whittier, California, United States, 90602
United States, Colorado
Alpine Clinical Research Center Suspended
Boulder, Colorado, United States, 80301
Denver Arthritis Clinic Recruiting
Denver, Colorado, United States, 80230
Contact: Christopher Antolini    303-394-2828   
Contact: Theresa Hernandez    303-394-2828 ext 177   
Principal Investigator: Christopher Antolini         
United States, Delaware
Javed Rheumatology Associates Recruiting
Newark, Delaware, United States, 19713
Contact: Sheerin Javed    302-633-9033   
Contact: Fran Miller    302-633-9033 ext 109   
Principal Investigator: Sheerin Javed         
United States, Florida
RASF - Clinical Research Center Recruiting
Boca Raton, Florida, United States, 33486
Contact: Joseph Forstot    561-361-6547   
Contact: Heather Gliatta    561-361-6547   
Principal Investigator: Joseph Forstot         
Suncoast Research Recruiting
Miami, Florida, United States, 33135
Contact: Mark Kutner    305-631-6704   
Contact: Ricahrd Garcia    305-631-6704 ext 127   
Principal Investigator: Mark Kutner         
Omega Research Consultants Recruiting
Orlando, Florida, United States, 32810
Contact: Kwabena Ayesu    407-271-8030   
Contact: Aracely Gonzalez    407-271-8030   
Principal Investigator: Kwabena Ayesu         
Family Clinical Trials, LLC. Recruiting
Pembroke Pines, Florida, United States, 33026
Contact: Jeanne-Elyse Cedeno    954-842-3147   
Contact: Lisbel Gonzalez    954-842-3147   
Principal Investigator: Jeanne-Elyse Cedeno         
McIlwain Medical Group, PA Recruiting
Tampa, Florida, United States, 33613
Contact: Harris McIlwain    813-345-2393   
Contact: Dianne Morales    813-345-2382   
Principal Investigator: Harris McIlwain         
United States, Georgia
Arthritis Center of North Georgia Not yet recruiting
Gainesville, Georgia, United States, 30501
Contact: Marta Bognar    770-531-3711   
Contact: Laura Corn    678-677-8824   
Principal Investigator: Marta Bognar         
United States, Idaho
Institute of Arthritis Research Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Craig Scoville    208-542-9080   
Contact: Carolina Saldana    208-542-9080   
Principal Investigator: Craig Scoville         
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
Contact: Mark Turner    208-377-8659   
Contact: Audra Weslowski    208-377-8653 ext 211   
Principal Investigator: Mark Turner         
United States, Kansas
University of Kansas Medical Center Research Institute, Inc. Withdrawn
Kansas City, Kansas, United States, 66160
United States, Kentucky
Graves Gilbert Clinic Recruiting
Bowling Green, Kentucky, United States, 42101
Contact: Asad Fraser    270-943-1302   
Contact: Mary Jo Marr    270-393-2786   
Principal Investigator: Asad Fraser         
Research Integrity, LLC. Withdrawn
Owensboro, Kentucky, United States, 42303
United States, Louisiana
The Arthritis & Diabetes Clinic, Inc. Recruiting
Monroe, Louisiana, United States, 71203
Contact: Jyothi Mallepalli    318-388-5830   
Contact: Leslie Hughes    318-812-1250   
Principal Investigator: Jyothi Mallepalli         
United States, Maryland
Klein and Associates, M.D., P.A. Suspended
Cumberland, Maryland, United States, 21502
Klein and Associates, M.D., P.A. Recruiting
Hagerstown, Maryland, United States, 21740
Contact: Mary Howell    301-714-1506   
Contact: Richard Robinson II    301-791-6680 ext 1137   
Principal Investigator: Mary Howell         
The Center for Rheumatology and Bone Research Recruiting
Wheaton, Maryland, United States, 20902
Contact: Herbert Baraf    301-942-6610   
Contact: Meghan Lormore    301-942-6610   
Principal Investigator: Herbert Baraf         
United States, Massachusetts
Clinical Pharmacology Study Group Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Charles Birbara    508-755-0201   
Contact: Mary Couglin    508-755-0201   
Principal Investigator: Charles Birbara         
United States, Montana
Glacier View Research Instutute-Rheumatology Recruiting
Kalispell, Montana, United States, 59901
Contact: Roger Diegel    406-755-1460   
Contact: Jaime Wyatt    406-755-1460   
Principal Investigator: Roger Diegel         
United States, Nebraska
Westroads Clinical Research Withdrawn
Omaha, Nebraska, United States, 68114
United States, New Jersey
Arthritis & Osteoporosis Associates, PA Recruiting
Freehold, New Jersey, United States, 07728
Contact: Hisham El-Kadi    732-780-7650   
Contact: Tara Lowenburg    732-410-4737   
Principal Investigator: Hisham El-Kadi         
United States, New Mexico
Lovelace Scientific Resources, Inc. Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Michael McGuire    505-348-9700   
Contact: Bonnie Gutierrez    505-348-9523   
Principal Investigator: Michael McGuire         
United States, New York
Center for Rheumatology Withdrawn
Albany, New York, United States, 12206
Weill Cornell Brain & Spine Center Recruiting
New York, New York, United States, 10021
Contact: David Goddard    929-455-2399   
Contact: Debra London    929-455-2585   
Principal Investigator: David Goddard         
United States, North Carolina
Medication Management, LLC Recruiting
Greensboro, North Carolina, United States, 27408
Contact: Nilamadhab Mishra    336-763-6968   
Contact: Casey Roberts    336-890-6015   
Principal Investigator: Nilamadhab Mishra         
Cape Fear Arthritis Care Recruiting
Leland, North Carolina, United States, 28451
Contact: David Snow    608-848-8900   
Contact: Olivia Anderson    710-679-3217   
Principal Investigator: David Snow         
Carolina Arthritis Associates Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Mark Harris    910-762-1182   
Contact: Jodi Daniel    910-762-1182 ext 1022   
Principal Investigator: Mark Harris         
United States, North Dakota
Trinity Medical Group Recruiting
Minot, North Dakota, United States, 58701
Contact: Erdal Diri    701-857-2510   
Contact: Janelle Rostad    701-857-2510   
Principal Investigator: Erdal Diri         
United States, Ohio
Cincinnati Rheumatic Disease Study Group Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Michael Luggen    513-559-2370   
Contact: Peggy Slattery    513-559-2370   
Principal Investigator: Michael Luggen         
STAT Research, Inc. Recruiting
Dayton, Ohio, United States, 45417
Contact: Sanford Wolfe    937-223-4229   
Contact: Lynette Tipton    937-223-4229   
Principal Investigator: Sanford Wolfe         
Clinical Research Source, Inc. Recruiting
Perrysburg, Ohio, United States, 43551
Contact: Edward Goldberger    419-873-1532   
Contact: Denise Coressel    419-873-1532   
Principal Investigator: Edward Goldberger         
United States, Pennsylvania
Arthritis Group Recruiting
Philadelphia, Pennsylvania, United States, 19152
Contact: James Udell    215-725-1710   
Contact: Donah Crawford    215-725-1710   
Principal Investigator: James Udell         
United States, South Carolina
Low Country Research Center Recruiting
Charleston, South Carolina, United States, 29406
Contact: William Edwards    843-572-4840   
Contact: Kellean Van Cleef    843-572-1818   
Principal Investigator: William Edwards         
United States, Texas
Allergy Asthma Rheumatology Treatment Specialist (ARTS) Recruiting
Amarillo, Texas, United States, 79124
Contact: Constantine Saadeh    806-353-7000   
Contact: Kelly Witcher    806-352-2453   
Principal Investigator: Constantine Saadeh         
Austin Regional Clinic, P.A. Recruiting
Austin, Texas, United States, 78731
Contact: Tina Bunch    512-344-0362   
Contact: Vivian Mills    512-344-0362   
Principal Investigator: Tina Bunch         
Accurate Clinical Research, Inc. Recruiting
Baytown, Texas, United States, 77521
Contact: Sabeen Najam    832-672-7973   
Contact: Jorge Gonzalez    832-500-8169   
Principal Investigator: Sabeen Najam         
Precision Comprehensive Clinical Research Solutions Not yet recruiting
Grapevine, Texas, United States, 76051
Contact: Dhiman Basu    972-829-8839   
Contact: Ashwin Boda    972-299-8399   
Principal Investigator: Dhiman Basu         
Accurate Clinical Management LLC Withdrawn
Houston, Texas, United States, 77004
Rheumatic Disease Clinical Research Center, LLC Recruiting
Houston, Texas, United States, 77004
Contact: Samuel Pegram    713-521-7865 ext 113   
Contact: Mary Rogers    713-341-5930   
Principal Investigator: Samuel Pegram         
Accurate Clinical Research, Inc. Recruiting
Houston, Texas, United States, 77034
Contact: Philip Waller    281-240-1045   
Contact: Jennifer Narvaez    832-500-8169   
Principal Investigator: Philip Waller         
Rheumatology Clinic of Houston, P.A. Recruiting
Houston, Texas, United States, 77065
Contact: Qaiser Rehman    281-517-0550 ext 402   
Contact: Kemal Baloch    281-517-0550 ext 402   
Principal Investigator: Qaiser Rehman         
Houston Institute For Clinical Research Withdrawn
Houston, Texas, United States, 77074
Pioneer Research Solutions, Inc. Recruiting
Houston, Texas, United States, 77099
Contact: Asif Cochinwala    713-333-9323   
Contact: Khurram Shah    713-333-9323   
Principal Investigator: Asif Cochinwala         
Arthritis & Osteoporosis Associates LLP Recruiting
Lubbock, Texas, United States, 79410
Contact: Jitendra Vasandani    806-993-1040   
Contact: Brenda Parrish    806-993-1040   
Principal Investigator: Jitendra Vasandani         
Arthritis & Osteoporosis Associates LLP Withdrawn
Lubbock, Texas, United States, 79424
Accurate Clinical Research, Inc. Recruiting
Nassau Bay, Texas, United States, 77058
Contact: Prashanth Sunkureddi    713-677-0086   
Contact: Jose Zamora    832-500-8169   
Principal Investigator: Prashanth Sunkureddi         
Dr. Alex De Jesus Rheumatology, P.A. Recruiting
San Antonio, Texas, United States, 78229
Contact: Alex De Jesus    210-762-6577   
Contact: Lisa Sanchez    832-500-8169   
Principal Investigator: Alex De Jesus         
Advanced Rheumatology of Houston Recruiting
Woodville, Texas, United States, 77382
Contact: Tamar Brionez    832-452-7249   
Contact: Rizwana Nouman    936-681-4882   
Principal Investigator: Tamar Brionez         
United States, Virginia
The Center For Arthritis and Rheumatic Diseases Withdrawn
Chesapeake, Virginia, United States, 23320
United States, West Virginia
The Rheumatology Group PLLC Recruiting
South Charleston, West Virginia, United States, 25309
Contact: Suzanne Gharib    304-389-4455   
Contact: Tammy Estep    304-389-4455   
Principal Investigator: Suzanne Gharib         
Hospital Italiano Regional del Sur Not yet recruiting
Bahia Blanca, Buenos Aires, Argentina, B8001HXM
Contact: Fabian Risueño    +542914557273   
Centro de Investigaciones Medicas Mar del Plata Not yet recruiting
Mar del Plata, Buenos Aires, Argentina, B7600FYK
Contact: Gladys Alicia Testa    +542234942575   
Instituto de Investigaciones Clinicas-Mar del Plata Not yet recruiting
Mar del Plata, Buenos Aires, Argentina, B7600FZ
Contact: Juan Pablo Gulin    +542234963224   
Instituto de Investigaciones Clinicas Quilmes Not yet recruiting
Quilmes, Buenos Aires, Argentina, B1878GEG
Contact: Jose Luis Velasco Zamora    +541142531337   
Clinica de Higado y Aparato Digestivo Not yet recruiting
Rosario, Santa Fe, Argentina, 52000
Contact: Judith Carrio    +5493414215777   
Sanatorio Delta Not yet recruiting
Rosario, Santa Fe, Argentina, S2000BIF
Contact: Juan Carlos Raggio    +54341679192915   
Sanatorio San Martin Not yet recruiting
Venado Tuerto, Santa Fe, Argentina, S2600KUE
Contact: Rosana Gallo    +543462155617485   
Centro Medico Privado de Reumatologia Not yet recruiting
San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
Contact: Alberto Jorge Spindler    +543814200180   
Centro de Investigaciones Reumatológicas Not yet recruiting
San Miguel de Tucuman, Tucuman, Argentina, T4000BRD
Contact: Eleonora del Valle Lucero    +543814301098   
Organizacion Medica de Investigacion (OMI) Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
Contact: Patricio Tate    +541143720308   
APRILLUS Not yet recruiting
Ciudad Autonoma Buenos aires, Argentina, C1046AAQ
Contact: Pablo Alejandro Mannucci    +541149512763   
Centro de Investigacion en Enfermedades Reumaticas CIER Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1055AAF
Contact: Pablo Jorge Maid    +541148156173   
Instituto Centenario Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1204AAD
Contact: Cecilia Asnal    +541149810256   
Hospital General de Agudos Dr. J. M. Ramos Mejia Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
Contact: Eduardo Kerzberg    +541149311178   
Atencion Integral en Reumatologia (AIR) Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
Contact: Horacio Oscar Venarotti    +541147812499   
Consultora Integral de Salud S.R.L. Not yet recruiting
Cordoba, Argentina, 5004
Contact: Veronica Savio    +543515890847   
Instituto DAMIC Fundacion Rusculleda Not yet recruiting
Cordoba, Argentina, X5003DCE
Contact: Gisela Constanza Subils    +543514888230   
Hospital Privado Centro Medico de Cordoba Not yet recruiting
Cordoba, Argentina, X5016KEH
Contact: Alejandro Jose Alvarellos    +543514688294   
Centro Polivalente de Asistencia e Inv. Clinica CER Not yet recruiting
San Juan, Argentina, J5402DIL
Contact: Jose Luis Cristian Moreno    +542644211086   
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará Not yet recruiting
Fortaleza, Ceará, Brazil, 60430-370
Contact: Leonardo Ribeiro Sampaio    +558533668590   
CEDOES - Diagnóstico e Pesquisa Not yet recruiting
Vitória, Espírito Santo, Brazil, 29055-450
Contact: Celso Ricardo Emerich de Abreu    +552721250220   
CIP - Centro Internacional de Pesquisa Not yet recruiting
Goiânia, Goiás, Brazil, 74110-120
Contact: Antônio Carlos Ximenes    +556232293280   
CMiP - Centro Mineiro de Pesquisa Not yet recruiting
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Contact: Antônio Scafuto Scotton    +553233128900   
CETI - Centro de Estudos em Terapias Inovadoras Ltda. Not yet recruiting
Curitiba, Paraná, Brazil, 80030-110
Contact: Sebastião Cézar Radominski    +554130223482   
Clinilive - Clínica do Idoso e Pesquisa Clínica Not yet recruiting
Maringá, Paraná, Brazil, 87014-250
Contact: Antônio Carlos de Silva    +554430293004   
Hospital Bruno Born Not yet recruiting
Lajeado, Rio Grande Do Sul, Brazil, 95900-000
Contact: Jussara Marilu Bohn    +555137147576   
LMK Serviços Médicos S/S Ltda Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
Contact: Mauro Waldemar Keiserman    +555133205057   
Faculdade de Medicina do ABC Not yet recruiting
Santo André, Sao Paulo, Brazil, 09060-650
Contact: Sônia Maria Alvarenga Anti Loduca Lima    +551149935606   
Hospital Estadual Mário Covas Not yet recruiting
Santo André, Sao Paulo, Brazil, 09190-610
Contact: Anna Maura Ferreira Fernandes    +551128295148   
HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro Not yet recruiting
Rio de Janeiro, Brazil, 21941-913
Contact: Luís Roimicher    +552125626241   
Hospital São Vicente de Paulo Not yet recruiting
Rio Grande, Brazil, 99010-080
Contact: Thaís Rohde Pavan    +555433164064   
Clínica de Neoplasias Litoral Ltda. Not yet recruiting
Santa Catarina, Brazil, 88301-220
Contact: Filipe Martins de Mello    +554733485093   
Hospital Abreu Sodré - AACD Not yet recruiting
Sao Paulo, Brazil, 04023-000
Contact: Morton Aaron Scheinberg    +551159048078   
CPCLIN - Centro de Pesquisas Clínicas Ltda. Not yet recruiting
São Paulo, Brazil, 01244-030
Contact: Flora Maria D'Andrea Marcolino    +551127110298   
Fundacion Hospital Universidad del Norte Not yet recruiting
Barranquilla, Colombia, 00000
Contact: Carlo Caballero    +5753587496   
Centro de Reumatologia y Ortopedia SAS Not yet recruiting
Barranquilla, Colombia, 080020
Contact: Juan Jose Jaller Raad    +5753450085   
Fundacion Instituto de Reumatologia Fernando Chalem Not yet recruiting
Bogota, Colombia, 00000
Contact: Philippe Chalem    +5713466423   
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM Not yet recruiting
Bogotá, Colombia
Contact: Patricia Julieta Velez Sanchez    +5716109131   
Medicity S.A.S. Not yet recruiting
Bucaramanga, Colombia, 0000
Contact: Diego Luis Saaibi    +575776399661   
Clinica de Artritis Temprana S.A. Not yet recruiting
Cali, Colombia, 00000
Contact: Carlos Enrique Toro    +5725240885   
Hospital Pablo Tobón Uribe Not yet recruiting
Medellín, Colombia, 050034
Contact: Javier Dario Marquez Hernandez    +5744459067   
Revmatologie MUDr. Klara Sirova s.r.o. Recruiting
Ostrava - Moravska Ostrava, Czechia, 70200
Contact: Klara Sirova    +420596123011   
MEDICAL PLUS s.r.o. Recruiting
Uherske Hradiste, Czechia, 68601
Contact: Eva Dokoupilova    +420572551850   
PV - Medical, s.r.o. Recruiting
Zlin, Czechia, 760 01
Contact: Petr Vitek    +420577221686   
Kerckhoff-Klinik gGmbH Recruiting
Bad Nauheim, Hessen, Germany, 61231
Contact: Ramona Koenig    +4960329962112   
CIRI - Centrum für Innovative Diagnostik und Therapie GmbH Recruiting
Frankfurt, Hessen, Germany, 60528
Contact: Frank Behrens    +496963017302   
Rheumazentrum Prof. Dr. G. Neeck Withdrawn
Bad Doberan, Mecklenburg Vorpommern, Germany, 18209
SMO.MD GmbH Recruiting
Magdeburg, Sachsen Anhalt, Germany, 39120
Contact: Cornelia Kuehne    +493916119511   
Rheumapraxis Dr. med. Reiner Kurthen Recruiting
Aachen, Germany, 52064
Contact: Reiner Kurthen    +4924123276   
Charite Universitaetsmedizin Berlin - Campus Charite Mitte Recruiting
Berlin, Germany, 10117
Contact: Gerd-Ruediger Burmester    +4930450513061   
HRF Hamburger Rheuma Forschungszentrum Recruiting
Hamburg, Germany, 20095
Contact: Andrea Everding    +491785262647   
Schoen Klinik Hamburg Eilbek Not yet recruiting
Hamburg, Germany, 22081
Contact: Juergen Wollenhaupt    +494020921356   
Clinexpert Egeszsegugyi Szolg. es Ker. Kft. Recruiting
Budapest, Hungary, 1033
Contact: Eszter Simoncsics    +3612108139   
Obudai Egeszsegugyi Centrum Recruiting
Budapest, Hungary, 1036
Contact: Magdolna Nagy    +3614367344   
MAV Korhaz és Rendelointezet Not yet recruiting
Szolnok, Hungary, 5000
Contact: Attila Kovacs    +3656524654   
Vital Medical Center Recruiting
Veszprem, Hungary, 8200
Contact: Edit Drescher    +3688556280   
Korea, Republic of
Ajou University Hospital Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
Contact: Chang-Hee Suh    +82312195118   
Pusan National University Hospital Not yet recruiting
Busan, Korea, Republic of, 49241
Contact: Seung-Geun Lee    82512407580   
Kangwon National University Hospital Not yet recruiting
Chuncheon, Korea, Republic of, 24289
Contact: Ki Won Moon    +82332582013   
Chonbuk National University Hospital Not yet recruiting
Chungbuk, Korea, Republic of, 54907
Contact: Wan Hee Yoo    +82632502579   
Chungnam National University Hospital Not yet recruiting
Daejeon, Korea, Republic of, 35015
Contact: Seung Cheol Shim    +82423382150   
Eulji University Hospital Recruiting
Daejeon, Korea, Republic of, 35233
Contact: Mi-Kyoung Lim    +82426113150   
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of, 61469
Contact: Shin-Seok Lee    +82622206590   
Hallym University Sacred Heart Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 14068
Contact: Hyun Ah Kim    +82313801826   
Jeju National University Hospital Not yet recruiting
Jeju, Korea, Republic of, 63241
Contact: Jinseok Kim    +82647171131   
Severance Hospital, Yonsei University Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Yong-Beom Park    +82222281967   
Hanyang University Seoul Hospital Withdrawn
Seoul, Korea, Republic of, 04763
The Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Ji Hyeon Ju    +82222586893   
Centro de Investigacion Clínica GRAMEL S.C Not yet recruiting
Mexico, Distrito Federal, Mexico, 03720
Contact: Luis Jara Quezada    +525552546698   
Clinstile, S.A. de C.V. Not yet recruiting
Mexico, Distrito Federal, Mexico, 06700
Contact: Favio Edmundo Enriquez Sosa    +525555334180   
Clinical Research Institute S.C. Not yet recruiting
Tlalnepantla, Estado De Mexico, Mexico, 54055
Contact: Miguel Saavedra Salinas    +525552651800 ext 4330   
Clinica de Investigacion en Reumatologia y Obesidad S.C. Not yet recruiting
Guadalajara, Jalisco, Mexico, 44650
Contact: Sergio Duran Barragan    +523338170562   
entro de Estudios de Investigacion Basica y Clinica SC Not yet recruiting
Guadalajara, Jalisco, Mexico, 44690
Contact: Ignacio Garcia Valladares    +523336165859   
Accelerium S. de R.L. de C.V. Not yet recruiting
Monterrey, Nuevo León, Mexico, 64000
Contact: Edmundo De la Garza Ramos    +528183461160   
Hospital y Clinica OCA SA de CV Not yet recruiting
Monterrey, Nuevo León, Mexico, 64000
Contact: Arturo Villarreal Ortega    +528114777005   
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez Not yet recruiting
Monterrey, Nuevo León, Mexico, 64460
Contact: Diana Flores Alvarado    +528183482015   
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C. Not yet recruiting
San Luis Potosi, San Luis Potos, Mexico, 78213
Contact: Juan Rizo Rodriguez    +524448084352   
Investigacion y Biomedicina de Chihuahua, S.C. Not yet recruiting
Chihuahua, Mexico, 31000
Contact: Cesar Pacheco Tena    +526144373002   
Szpital Uniwersytecki nr 2 im.dr J. Biziela Recruiting
Bydgoszcz, Poland, 85-168
Contact: Iwona Dankiewicz-Fares    +48523655631   
McBk S.C. Recruiting
Grodzisk Mazowiecki, Poland, 05-825
Contact: Krystyna Jedrychowicz-Rosiak    +48602184985   
Polimedica Centrum Badań, Profilaktyki I Leczenia Recruiting
Kielce, Poland, 25-364
Contact: Mirella Wojtecka-Grabka    +48693163758   
Centrum Medyczne AMED Recruiting
Lodz, Poland, 91-347
Contact: Anna Dudek    +4848224004041   
Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego Recruiting
Sieradz, Poland, 98-200
Contact: Robert Kolacinski    +48602115037   
Samodzielny Publiczny ZOZ Tomaszow Lubelski Recruiting
Tomaszow Lubelski, Poland, 22-600
Contact: Andrzej Kaminski    +48609594722   
Principal Investigator: Andrzej Kaminski         
McM Polimedica Recruiting
Warszawa, Poland, 02-777
Contact: Anna Rowinska-Osuch    +48224046878   
Santa Familia Centrum Badan, Profilaktyki i Leczenia Withdrawn
Zgierz, Poland, 95-100
Russian Federation
Medical Center LLC "Maksimum Zdoroviya" Withdrawn
Kemerovo, Kemerovo Oblast, Russian Federation, 650056
SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans" Withdrawn
Kemerovo, Kemerovskaya Oblast, Russian Federation, 650000
SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit Withdrawn
Saint Petersburg, Leningradskaya Oblast, Russian Federation, 190068
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital #1 n.a. Pirogov" Healthcare Departament of Moscow Recruiting
Moscow, Moscovskaya Oblast, Russian Federation, 119094
Contact: Evgeniya Shmidt    +7 (916) 655-48-81   
Principal Investigator: Evgeniya Shmidt         
State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department Recruiting
Moscow, Moscow Region, Russian Federation, 111539
Contact: Ivan Gordeev    +79265345912   
Principal Investigator: Ivan Gordeev         
SBHI of the Republic of Karelia "Republican Hospital named after V.A.Baranov" Recruiting
Petrozavodsk, Republic Of Karelia, Russian Federation, 185019
Contact: Natalia Vezikova    +79114014021   
Principal Investigator: Natalia Vezikova         
SBHI of Stavropol Region "Stavropol Regional Clinical Hospital" Recruiting
Stavropol', Stavropol Region, Russian Federation, 355017
Contact: Alexander Yagoda    +79064907330   
Principal Investigator: Alexander Yagoda         
State Autonomous Healthcare Institution "Republican Clinical Hospital of Ministry of Health of Tatarstan Republic Withdrawn
Kazan', The Republic Of Tatarstan, Russian Federation, 420064
FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova" Recruiting
Moscow, Russian Federation, 115522
Contact: Marina Stanislav    +79166920666   
Principal Investigator: Marina Stanislav         
Hacettepe University Medical Faculty Hospital, Rheumatology Departament Withdrawn
Ankara, Altindag, Turkey, 06230
Istanbul University, Istanbul Medical Faculty Internal Diseases Departament, Rheumatology Discipline Withdrawn
Istanbul, Fatih, Turkey, 34093
Istanbul University, Cerrahpasa Faculty o Medicine, Departament of Internal Medicine, Division of Rheumatology Withdrawn
Istanbul, Fatih, Turkey, 34098
Sponsors and Collaborators
Quintiles, Inc.
OCT Clinical Trials
Mene Research
Layout table for investigator information
Study Director: Mikhail Samsonov R-Pharm

Layout table for additonal information
Responsible Party: R-Pharm Identifier: NCT02760433     History of Changes
Other Study ID Numbers: CL04041025
2015-005308-27 ( EudraCT Number )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Keywords provided by R-Pharm:
moderate Rheumatoid Arthritis
severe Rheumatoid Arthritis

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors