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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

  • Clinicaltrials.gov identifier

    NCT04909801

  • Recruitment Status

    Recruiting

  • First Posted

    June 2, 2021

  • Last update posted

    December 21, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Rheumatoid Arthritis
  • Intervention/Treatment: Drug: Abatacept
    Drug: Adalimumab
    Drug: Methotrexate
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 300 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate
  • Actual Study Start Date: September 2021
  • Estimated Primary Completion Date: May 2025
  • Estimated Study Completion Date: May 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Arm 1: Abatacept + Methotrexate
Drug: Abatacept
Abatacept SC (125 mg) once weekly

Drug: Methotrexate
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Experimental: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)
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)

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of shared epitope-positive (SE+) participants meeting 50% improvement in American College of Rheumatology criteria (ACR50) response [ Time Frame: At week 24 ]
  • Secondary Outcome Measures: 1. Proportion of SE+ participants achieving Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) remission (DAS28-CRP < 2.6) [ Time Frame: At week 24 ]
  • 2. Proportion of whole study population participants meeting ACR50 response [ Time Frame: At week 24 ]
  • 3. Proportion of SE+ participants achieving Clinical Disease Activity Index (CDAI) remission (CDAI ≤ 2.8) [ Time Frame: At week 24 ]
  • 4. Mean change from baseline in SE+ participant-reported pain by visual analog scale (VAS) [ Time Frame: At week 24 ]
  • 5. Proportion of SE+ subset achieving 20% improvement in American College of Rheumatology criteria (ACR20) responses [ Time Frame: Up to 104 weeks ]
  • 6. Proportion of SE+ whole population achieving ACR20 responses [ Time Frame: Up to 104 weeks ]
  • 7. Proportion of SE+ subset achieving 50% improvement in American College of Rheumatology criteria (ACR50) responses [ Time Frame: Up to 104 weeks ]
  • 8. Proportion of SE+ whole population achieving ACR50 responses [ Time Frame: Up to 104 weeks ]
  • 9. Proportion of SE+ subset achieving 70% improvement in American College of Rheumatology criteria (ACR70) responses [ Time Frame: Up to 104 weeks ]
  • 10. Proportion of SE+ whole population achieving ACR70 responses [ Time Frame: Up to 104 weeks ]
  • 11. Proportion of SE+ subset achieving Disease Activity Score (DAS) remission [ Time Frame: Up to 104 weeks ]
  • 12. Proportion of SE+ whole population achieving DAS remission [ Time Frame: Up to 104 weeks ]
  • 13. Proportion of SE+ subset achieving Clinical Disease Activity Index (CDAI) remission [ Time Frame: Up to 104 weeks ]
  • 14. Proportion of SE+ whole population achieving CDAI remission [ Time Frame: Up to 104 weeks ]
  • 15. Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Single-blind Treatment Period (SBTP) [ Time Frame: Up to 104 weeks ]
  • 16. Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Open-label Treatment Period (OLTP) [ Time Frame: Up to 104 weeks ]
  • 17. Proportion of SE+ whole population achieving SDAI remission over the SBTP [ Time Frame: Up to 104 weeks ]
  • 18. Proportion of SE+ whole population achieving SDAI remission over the OLTP [ Time Frame: Up to 104 weeks ]
  • 19. Mean changes from baseline in DAS28-CRP [ Time Frame: Up to 104 weeks ]
  • 20. Mean changes from baseline in CDAI [ Time Frame: Up to 104 weeks ]
  • 21. Mean changes from baseline in SDAI over the SBTP [ Time Frame: Up to 104 weeks ]
  • 22. Mean changes from baseline in SDAI over the OLTP [ Time Frame: Up to 104 weeks ]
  • 23. Mean changes from baseline in the 7 ACR core components over the SBTP [ Time Frame: Up to 104 weeks ]
  • 24. Mean changes from baseline in the 7 ACR core components over the OLTP [ Time Frame: Up to 104 weeks ]
  • 25. Mean change from baseline in 36-item Short Form Survey (SF-36) in SE+ subset at week 24 and week 104 [ Time Frame: Up to 104 weeks ]
  • 26. Mean change from baseline in SF-36 in SE+ whole population at week 24 and week 104 [ Time Frame: Up to 104 weeks ]

Eligibility Criteria

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
St Joseph Heritage Healthcare-Rheumatology
Fullerton

United States, California
Local Institution
Los Alamitos

United States, Colorado
Local Institution
Aurora

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

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

United States, Missouri
Local Institution
Saint Louis

United States, Nebraska
Local Institution
Lincoln

United States, New Jersey
Local Institution
Freehold

United States, North Carolina
Local Institution
Wilmington

United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville

United States, Tennessee
West Tennessee Research Institute
Jackson

United States, Texas
Metroplex Clinical Research Center
Dallas

United States, Wisconsin
Local Institution
Glendale

Argentina, Buenos Aires
Local Institution
C.a.b.a.

Argentina, Buenos Aires
Local Institution
La Plata

Argentina, Buenos Aires
Local Institution
Quilmes

Argentina, Buenos Aires
Local Institution
San Isidro

Argentina, Distrito Federal
Local Institution
DQG

Argentina, Tucuman
Local Institution
San Miguel de Tucumán

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Cordoba

Australia, New South Wales
Local Institution
Botany

Australia, New South Wales
Local Institution
Parramatta

Australia, Queensland
Local Institution
Maroochydore

Australia, South Australia
Local Institution
Woodville South

Australia, Victoria
Local Institution
Camberwell

Australia, Victoria
Local Institution
Geelong

Australia, Victoria
Local Institution
Ivanhoe

Czechia
Revmatologie s.r.o.
Brno

Czechia
Local Institution
Praha

France
Local Institution
Montpellier

France
Local Institution
Rouen

France
Local Institution
Strasbourg

France
Local Institution
Toulouse

Germany
Local Institution
Berlin

Germany
Local Institution
Bonn

Germany
Local Institution
Freiburg im Breisgau

Germany
Local Institution
Hamburg

Germany
Local Institution
Planegg

Italy
Local Institution
Catania

Italy
Local Institution
Pavia

Italy
Local Institution
Perugia

Italy
Local Institution
Rome

Japan, Aichi
Local Institution
Nagoya

Japan, Fukuoka
Local Institution
Kitakyushu-shi

Japan, Hokkaido
Local Institution
Sapporo

Japan, Miyagi
Local Institution
Sendai

Japan, Nagasaki
Local Institution
Sasebo

Japan, Saitama
Local Institution
Kawagoe

Japan, Tokyo
Local Institution
Shinjuku-ku

Japan
Local Institution
Tokyo

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Yucatan
Local Institution
Merida

Mexico
Local Institution
Chihuahua

Mexico
Local Institution
San Luis Potosi

Poland
Local Institution
Bydgoszcz

Poland
Local Institution
Bydgoszcz

Poland
Local Institution
Elblag

Poland
Local Institution
Torun

Spain
Local Institution
A Coruna

Spain
Local Institution
Madrid

Spain
Local Institution
Santander

Switzerland
Local Institution
Basel

Switzerland
Local Institution
St. Gallen

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
New Taipei City

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Tainan

Taiwan
Local Institution
Tainan

United Kingdom
Local Institution
Greater London, London

United Kingdom
Local Institution
Hull

United Kingdom
Local Institution
Wolverhampton

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04909801 History of Changes
  • Other Study ID Numbers: IM101-863, 2020-000350-96, U1111-1247-1367
  • First Posted: June 2, 2021 Key Record Dates
  • Last Update Posted: December 21, 2021
  • Last Verified: December 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Abatacept
    Adalimumab
    BMS-188667
    Humira®
    Methotrexate
    Orencia®
    Rheumatoid Arthritis
  • Additional relevant MeSH terms: Arthritis
    Arthritis, Rheumatoid
    Joint Diseases
    Musculoskeletal Diseases
    Rheumatic Diseases
    Connective Tissue Diseases
    Autoimmune Diseases
    Immune System Diseases