Clinical Trial Details

NCT ID: NCT02557100
Date Last Changed: October 17, 2017

Overview

Research Study Summary

A clinical research study of Abatacept, Adalimumab and Methotrexate for the treatment of Rheumatoid Arthritis

Research Study Title

A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Purpose

The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate.

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Recruitment Details

Phase
4
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Bristol-Myers Squibb
Duration
30 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Symptoms of RA for no more than 12 months prior to enrollment

  • Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR) 2010 criteria for classification of RA

  • Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a stable oral dose for at least 4 weeks, Subjects must randomize on the maximum tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week), dose of MTX < 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to higher doses

  • At least 3 tender & 3 swollen joints

  • Anti-cyclic citrullinated peptide (CCP) > 3X the upper limit of normal and positive rheumatoid factor

Exclusion Criteria:

  • History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus, etc)

  • Prior use of non-biologic therapy other than methotrexate

  • Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARD) therapy

  • Subjects with chronic or recent acute serious infection

Other protocol defined inclusion/exclusion criteria could apply

Site Locations (27)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35294-7201 University Of Alabama At Birmingham
Jeffrey Curtis, Site 0020
205-934-9843
United States Alabama Huntsville 35801 Rheumatology Associates Of North Alabama, P.C.
William Shergy, Site 0017
256-704-7098
United States Alabama Tuscaloosa 35406 Clinical And Translational Research Center Of Alabama, Pc
Richard Jones, Site 0012
205-464-4711
United States Arizona Glendale 85306 Arizona Arthritis & Rheumatology Research PLLC
John Tesser, Site 0015
602-386-4969
United States Arizona Phoenix 85037 Arizona Arthritis & Rheumatology Research PLLC
Nehad Soloman, Site 0016
623-512-4802
United States California Fullerton 92835 St. Joseph Heritage Medical Group
Shirley Pang, Site 0001
714-992-3000
United States California Palm Desert 92260 Desert Medical Advances
Maria Greenwald, Site 0005
760-341-6800
United States Colorado Aurora 80045 University Of Colorado Health Sciences Center
Christopher Striebich, Site 0007
303-724-7607
United States District of Columbia Washington, D.C. 20037 Medical Faculty Associates,Inc.
Adey Berhanu, Site 0010
202-994-8567
United States District of Columbia Washington, D.C. 20060 Howard University Hospital
Gail Kerr, Site 0019
202-865-3326
United States Florida Plantation 33324 Integral Rheumatology & Immunology Specialists
Guillermo Valenzuela, Site 0002
954-476-2338
United States Georgia Marietta 30060 Marietta Rheumatology
Mohammed Abubaker, Site 0013
770-372-3962
United States Maryland Wheaton 20902 The Center For Rheumatology And Bone Research
Paul Demarco, Site 0014
301-942-6610
United States Massachusetts Worcester 01605 Clinical Pharmacology Study Group
Charles Birbara, Site 0021
508-755-0201
United States Michigan Grand Blanc 98439 Aa Mrc Llc
Ali Karrar, Site 0011
810-237-1125
United States New Hampshire Lebanon 03756 Dartmouth-Hitchcock Medical Center
William Rigby, Site 0004
603-650-4717
United States Oregon Portland 97239 Oregon Health & Science University (Ohsu)
Cong-Qiu Chu, Site 0018
503-494-5571
United States Pennsylvania Duncansville 16635-8406 Altoona Center For Clinical Research
Alan Kivitz, Site 0009
814-693-0300
United States Tennessee Jackson 38305 West Tennessee Research Institute
Jacob Aelion, Site 0003
731-633-0119
United States Virginia Arlington 22205 Arthritis Clinic Of Northern Virginia, P.C.
Phillip Kempf, Site 0006
703-525-3069
Canada Ontario Toronto M9V 4B4 Dr. Anil K Gupta Med Prof Corp
Anil Gupta, Site 0025
4167411500
Canada Ontario Windsor N8X 5A6 Essex County Medical Society
Sabeen Anwar, Site 0026
5192524448
Canada Quebec Montreal H2L 1S6 Institut De Rhumatologie De Montreal
Boulos Haraoui, Site 0023
5145238603
Canada Quebec Trois-rivieres G8Z 1Y2 Centre De Recherche Musculo-Squelettique
Frederic Morin, Site 0024
8193701301
Mexico Distrito Federal Mexico City 11850 CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
Fedra Consuelo Irazoque Palazuelos, Site 0027
+525526143031
Mexico Jalisco Guadalajara 44650 Clinica de Investigacion en Reumatologia y Obesidad S.C.
Sergio Duran Barragan, Site 0029
+523338250000
Mexico Mexico D.F. 06760 Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.
Maria de Jesus Araujo Arias, Site 0028
525552648591

Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:

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