A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Study Purpose

The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period.
  • - Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA.
  • - Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization.
  • - Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening.
  • - At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening.
  • - At least 3 tender and at least 3 swollen joints at screening and at randomization.

Exclusion Criteria:

  • - Women who are breastfeeding.
  • - Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia.
  • - History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease) - At risk for tuberculosis.
  • - Recent acute infection.
  • - History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis) - History of infection of a joint prosthesis or artificial joint.
  • - History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis) - History of primary immunodeficiency.
  • - Current clinical findings or a history of a demyelinating disorder.
  • - 5 or more joints cannot be assessed for tenderness or swelling.
Other protocol-defined inclusion/exclusion criteria apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04909801
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Spain, Switzerland, Taiwan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Arm 1: Abatacept + Methotrexate

Experimental: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)

Interventions

Drug: - Abatacept

Abatacept SC (125 mg) once weekly

Drug: - Adalimumab

Adalimumab SC (40 mg) once every 2 weeks

Drug: - Methotrexate

Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Fullerton, California

Status

Recruiting

Address

St Joseph Heritage Healthcare-Rheumatology

Fullerton, California, 92835

Site Contact

Shirley Pang, Site 0036

[email protected]

714-833-4831

Los Alamitos, California

Status

Recruiting

Address

Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

Los Alamitos, California, 90720

Site Contact

Nathaniel Neal, Site 0086

[email protected]

855-907-3286

Aurora, Colorado

Status

Recruiting

Address

Barbara Davis Center for Childhood Diabetes-Rheumatology

Aurora, Colorado, 80045

Site Contact

Christopher Striebich, Site 0041

[email protected]

303-506-0827

Klein And Associates, M.D., Pa, Cumberland, Maryland

Status

Recruiting

Address

Klein And Associates, M.D., Pa

Cumberland, Maryland, 21502

Site Contact

Steven Klein, Site 0058

[email protected]s.com

301-724-4337

Klein & Associates, M.D., P.A., Hagerstown, Maryland

Status

Recruiting

Address

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, 21740

Site Contact

Mary Howell, Site 0038

[email protected]

301-791-6680

Saint Paul Rheumatology, Eagan, Minnesota

Status

Recruiting

Address

Saint Paul Rheumatology

Eagan, Minnesota, 55121

Site Contact

David Ridley, Site 0084

[email protected]

651-361-8659

Local Institution, Saint Louis, Missouri

Status

Not yet recruiting

Address

Local Institution

Saint Louis, Missouri, 63141

Site Contact

Site 0094

[email protected]

855-907-3286

Local Institution, Lincoln, Nebraska

Status

Withdrawn

Address

Local Institution

Lincoln, Nebraska, 68516

Freehold, New Jersey

Status

Recruiting

Address

Arthritis & Osteoporosis Associates - Freehold

Freehold, New Jersey, 07728

Site Contact

Hisham El-Kadi, Site 0040

[email protected]

732-410-6840

Brooklyn, New York

Status

Withdrawn

Address

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201

Carolina Arthritis Associates, Wilmington, North Carolina

Status

Recruiting

Address

Carolina Arthritis Associates

Wilmington, North Carolina, 28401

Site Contact

MARK HARRIS, Site 0082

[email protected]

855-907-3286

Oregon Health and Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University

Portland, Oregon, 97239

Site Contact

Atulya Deodhar, Site 0127

[email protected]

503-494-7711

Altoona Center For Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

Site Contact

Alan Kivitz, Site 0031

[email protected]

814-934-4368

West Tennessee Research Institute, Jackson, Tennessee

Status

Recruiting

Address

West Tennessee Research Institute

Jackson, Tennessee, 38305

Site Contact

Jacob Aelion, Site 0034

[email protected]

731-664-0002

Metroplex Clinical Research Center, Dallas, Texas

Status

Recruiting

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

Site Contact

Roy Fleischmann, Site 0044

[email protected]

214-879-6737

Rheumatic Disease Center, Milwaukee, Wisconsin

Status

Recruiting

Address

Rheumatic Disease Center

Milwaukee, Wisconsin, 53217

Site Contact

Kurt Oelke, Site 0119

[email protected]

414-351-4009

International Sites

Local Institution - 0012, Caba, Buenos Aires, Argentina

Status

Recruiting

Address

Local Institution - 0012

Caba, Buenos Aires, C1015

Site Contact

Site 0012

[email protected]

855-907-3286

Local Institution, La Plata, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Local Institution

La Plata, Buenos Aires, 1900

Site Contact

Site 0024

[email protected]

855-907-3286

Local Institution - 0016, Quilmes, Buenos Aires, Argentina

Status

Recruiting

Address

Local Institution - 0016

Quilmes, Buenos Aires, 1878

Site Contact

Site 0016

[email protected]

855-907-3286

Local Institution - 0014, San Isidro, Buenos Aires, Argentina

Status

Recruiting

Address

Local Institution - 0014

San Isidro, Buenos Aires, 1642

Site Contact

Site 0014

[email protected]

855-907-3286

Local Institution, DQG, Distrito Federal, Argentina

Status

Not yet recruiting

Address

Local Institution

DQG, Distrito Federal, C1428

Site Contact

Site 0022

[email protected]

855-907-3286

Local Institution - 0057, San Miguel de Tucumán, Tucuman, Argentina

Status

Recruiting

Address

Local Institution - 0057

San Miguel de Tucumán, Tucuman, T4000

Site Contact

Site 0057

[email protected]

855-907-3286

Local Institution - 0023, Buenos Aires, Argentina

Status

Recruiting

Address

Local Institution - 0023

Buenos Aires, , 1428

Site Contact

Site 0023

[email protected]

855-907-3286

Local Institution - 0015, Buenos Aires, Argentina

Status

Recruiting

Address

Local Institution - 0015

Buenos Aires, , 1431

Site Contact

Site 0015

[email protected]

855-907-3286

Local Institution - 0099, Cordoba, Argentina

Status

Recruiting

Address

Local Institution - 0099

Cordoba, , 0

Site Contact

Site 0099

[email protected]

855-907-3286

Local Institution, Botany, New South Wales, Australia

Status

Recruiting

Address

Local Institution

Botany, New South Wales, 2019

Site Contact

Site 0072

[email protected]

855-907-3286

Local Institution - 0062, Paramatta, New South Wales, Australia

Status

Recruiting

Address

Local Institution - 0062

Paramatta, New South Wales, 2150

Site Contact

Site 0062

[email protected]

855-907-3286

Local Institution - 0063, Maroochydore, Queensland, Australia

Status

Recruiting

Address

Local Institution - 0063

Maroochydore, Queensland, 4558

Site Contact

Site 0063

[email protected]

855-907-3286

Local Institution - 0102, Woodville South, South Australia, Australia

Status

Recruiting

Address

Local Institution - 0102

Woodville South, South Australia, 5001

Site Contact

Site 0102

[email protected]

855-907-3286

Local Institution - 0064, Camberwell, Victoria, Australia

Status

Recruiting

Address

Local Institution - 0064

Camberwell, Victoria, 3124

Site Contact

Site 0064

[email protected]

855-907-3286

Local Institution - 0065, Geelong, Victoria, Australia

Status

Recruiting

Address

Local Institution - 0065

Geelong, Victoria, 3220

Site Contact

Site 0065

[email protected]

855-907-3286

Local Institution - 0105, Ivanhoe, Victoria, Australia

Status

Recruiting

Address

Local Institution - 0105

Ivanhoe, Victoria, 3079

Site Contact

Site 0105

[email protected]

855-907-3286

Local Institution - 0028, Brno, Czechia

Status

Recruiting

Address

Local Institution - 0028

Brno, , 638 00

Site Contact

Site 0028

[email protected]

855-907-3286

Local Institution - 0025, Praha 2, Czechia

Status

Recruiting

Address

Local Institution - 0025

Praha 2, , 12850

Site Contact

Site 0025

[email protected]

855-907-3286

Local Institution - 0001, Montpellier, France

Status

Recruiting

Address

Local Institution - 0001

Montpellier, , 34295

Site Contact

Site 0001

[email protected]

855-907-3286

Local Institution - 0047, Rouen, France

Status

Recruiting

Address

Local Institution - 0047

Rouen, , 76031

Site Contact

Site 0047

[email protected]

855-907-3286

Strasbourg, France

Status

Recruiting

Address

CHU Strasbourg-Hautepierre-Service de Rhumatologie

Strasbourg, , 67098

Site Contact

Jean Sibilia, Site 0035

[email protected]

+0033388127954

Local Institution - 0002, Toulouse, France

Status

Recruiting

Address

Local Institution - 0002

Toulouse, , 31059

Site Contact

Site 0002

[email protected]

855-907-3286

Local Institution - 0059, Berlin, Germany

Status

Recruiting

Address

Local Institution - 0059

Berlin, , 10117

Site Contact

Site 0059

[email protected]

855-907-3286

Local Institution - 0055, Bonn, Germany

Status

Recruiting

Address

Local Institution - 0055

Bonn, , 53127

Site Contact

Site 0055

[email protected]

855-907-3286

Local Institution - 0091, Freiburg, Germany

Status

Recruiting

Address

Local Institution - 0091

Freiburg, , 79106

Site Contact

Site 0091

[email protected]

855-907-3286

Local Institution - 0053, Hamburg, Germany

Status

Recruiting

Address

Local Institution - 0053

Hamburg, , 20095

Site Contact

Site 0053

[email protected]

855-907-3286

Local Institution - 0056, Planegg, Germany

Status

Recruiting

Address

Local Institution - 0056

Planegg, , 82152

Site Contact

Site 0056

[email protected]

855-907-3286

Local Institution - 0083, Catania, Italy

Status

Recruiting

Address

Local Institution - 0083

Catania, , 95121

Site Contact

Site 0083

[email protected]

855-907-3286

Local Institution - 0077, Pavia, Italy

Status

Recruiting

Address

Local Institution - 0077

Pavia, , 27100

Site Contact

Site 0077

[email protected]

855-907-3286

Local Institution - 0078, Perugia, Italy

Status

Recruiting

Address

Local Institution - 0078

Perugia, , 06156

Site Contact

Site 0078

[email protected]

855-907-3286

Local Institution - 0100, Roma, Italy

Status

Recruiting

Address

Local Institution - 0100

Roma, , 00168

Site Contact

Site 0100

[email protected]

855-907-3286

Local Institution - 0093, Nagoya, Aichi, Japan

Status

Recruiting

Address

Local Institution - 0093

Nagoya, Aichi, 457-8511

Site Contact

Site 0093

[email protected]

855-907-3286

Local Institution - 0079, Kitakyushu, Fukuoka, Japan

Status

Recruiting

Address

Local Institution - 0079

Kitakyushu, Fukuoka, 807-8556

Site Contact

Site 0079

[email protected]

855-907-3286

Local Institution - 0110, Sapporo, Hokkaido, Japan

Status

Recruiting

Address

Local Institution - 0110

Sapporo, Hokkaido, 0608648

Site Contact

Site 0110

[email protected]

855-907-3286

Local Institution - 0046, Sendai-shi, Miyagi, Japan

Status

Recruiting

Address

Local Institution - 0046

Sendai-shi, Miyagi, 980-8574

Site Contact

Site 0046

[email protected]

855-907-3286

Local Institution - 0112, Sasebo, Nagasaki, Japan

Status

Recruiting

Address

Local Institution - 0112

Sasebo, Nagasaki, 857-1195

Site Contact

Site 0112

[email protected]

855-907-3286

Local Institution - 0090, Kawagoe-shi, Saitama, Japan

Status

Recruiting

Address

Local Institution - 0090

Kawagoe-shi, Saitama, 3508550

Site Contact

Site 0090

[email protected]

855-907-3286

Local Institution - 0089, Tokyo, Japan

Status

Recruiting

Address

Local Institution - 0089

Tokyo, , 104-8560

Site Contact

Site 0089

[email protected]

855-907-3286

Local Institution - 0010, Tokyo, Japan

Status

Recruiting

Address

Local Institution - 0010

Tokyo, , 1600035

Site Contact

Site 0010

[email protected]

855-907-3286

Local Institution - 0006, Cdmx, Distrito Federal, Mexico

Status

Recruiting

Address

Local Institution - 0006

Cdmx, Distrito Federal, 11850

Site Contact

Site 0006

[email protected]

855-907-3286

Local Institution - 0008, Mexico City, Distrito Federal, Mexico

Status

Recruiting

Address

Local Institution - 0008

Mexico City, Distrito Federal, 14080

Site Contact

Site 0008

[email protected]

855-907-3286

Local Institution - 0017, Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

Local Institution - 0017

Guadalajara, Jalisco, 44650

Site Contact

Site 0017

[email protected]

855-907-3286

Local Institution - 0117, Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

Local Institution - 0117

Guadalajara, Jalisco, 44650

Site Contact

Site 0117

[email protected]

855-907-3286

Local Institution - 0118, San Luis Potosí, SAN LUIS Potosi, Mexico

Status

Recruiting

Address

Local Institution - 0118

San Luis Potosí, SAN LUIS Potosi, 78200

Site Contact

Site 0118

[email protected]

855-907-3286

Local Institution - 0005, Mérida, Yucatán, Mexico

Status

Recruiting

Address

Local Institution - 0005

Mérida, Yucatán, 97070

Site Contact

Site 0005

[email protected]

855-907-3286

Local Institution - 0009, Chihuahua, Mexico

Status

Recruiting

Address

Local Institution - 0009

Chihuahua, , 31000

Site Contact

Site 0009

[email protected]

855-907-3286

Local Institution - 0124, Bydgoszcz, Poland

Status

Recruiting

Address

Local Institution - 0124

Bydgoszcz, , 85-168

Site Contact

Site 0124

[email protected]

855-907-3286

Local Institution, Bydgoszcz, Poland

Status

Not yet recruiting

Address

Local Institution

Bydgoszcz, , 85-168

Site Contact

Site 0018

[email protected]

855-907-3286

Local Institution - 0019, Elblag, Poland

Status

Recruiting

Address

Local Institution - 0019

Elblag, , 82-300

Site Contact

Site 0019

[email protected]

855-907-3286

Local Institution - 0020, Torun, Poland

Status

Recruiting

Address

Local Institution - 0020

Torun, , 87-100

Site Contact

Site 0020

[email protected]

855-907-3286

Local Institution - 0004, A Coruña, Spain

Status

Recruiting

Address

Local Institution - 0004

A Coruña, , 15006

Site Contact

Site 0004

[email protected]

855-907-3286

Local Institution - 0003, Madrid, Spain

Status

Recruiting

Address

Local Institution - 0003

Madrid, , 28046

Site Contact

Site 0003

[email protected]

855-907-3286

Local Institution - 0085, Santander, Spain

Status

Recruiting

Address

Local Institution - 0085

Santander, , 39008

Site Contact

Site 0085

[email protected]

855-907-3286

Local Institution - 0049, Basel, Switzerland

Status

Recruiting

Address

Local Institution - 0049

Basel, , 4031

Site Contact

Site 0049

[email protected]

855-907-3286

Local Institution - 0052, St. Gallen, Switzerland

Status

Recruiting

Address

Local Institution - 0052

St. Gallen, , 9007

Site Contact

Site 0052

[email protected]

855-907-3286

Local Institution - 0098, Kaohsiung Niao Sung Dist, Taiwan

Status

Recruiting

Address

Local Institution - 0098

Kaohsiung Niao Sung Dist, , 83301

Site Contact

Site 0098

[email protected]

855-907-3286

Local Institution - 0104, New Taipei City, Taiwan

Status

Recruiting

Address

Local Institution - 0104

New Taipei City, , 220

Site Contact

Site 0104

[email protected]

855-907-3286

Local Institution - 0095, Taichung City, Taiwan

Status

Recruiting

Address

Local Institution - 0095

Taichung City, , 402

Site Contact

Site 0095

[email protected]

855-907-3286

Local Institution - 0096, Taichung, Taiwan

Status

Recruiting

Address

Local Institution - 0096

Taichung, , 40447

Site Contact

Site 0096

[email protected]

855-907-3286

Local Institution - 0120, Tainan, Taiwan

Status

Recruiting

Address

Local Institution - 0120

Tainan, , 704

Site Contact

Site 0120

[email protected]

855-907-3286

Local Institution, Tainan, Taiwan

Status

Withdrawn

Address

Local Institution

Tainan, , 71004

Local Institution - 0111, Cannock, Staffordshire, United Kingdom

Status

Recruiting

Address

Local Institution - 0111

Cannock, Staffordshire, WS11 5XY

Site Contact

Site 0111

[email protected]

855-907-3286

Local Institution, Greater London, London, United Kingdom

Status

Recruiting

Address

Local Institution

Greater London, London, , SE1 1UL

Site Contact

Site 0114

[email protected]

855-907-3286

Local Institution - 0060, Hull, United Kingdom

Status

Recruiting

Address

Local Institution - 0060

Hull, , HU3 2JZ

Site Contact

Site 0060

[email protected]

855-907-3286