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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04909801
• Other study ID #: IM101-863
• Secondary ID: 2020-000350-96U1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 15, 2021
• Est. completion date: September 3, 2025

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 327
• Est. completion date: September 3, 2025
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept
Abatacept SC (125 mg) once weekly
• Adalimumab
Adalimumab SC (40 mg) once every 2 weeks
• Methotrexate
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)

Locations

Country	Name	City	State
Argentina	Local Institution - 0015	Buenos Aires
Argentina	Local Institution - 0022	Buenos Aires
Argentina	Local Institution - 0023	Buenos Aires
Argentina	Local Institution - 0012	Caba	Buenos Aires
Argentina	Local Institution - 0099	Cordoba
Argentina	Local Institution - 0016	Quilmes	Buenos Aires
Argentina	Local Institution - 0014	San Isidro	Buenos Aires
Argentina	Local Institution - 0057	San Miguel de Tucumán	Tucuman
Australia	Local Institution - 0072	Botany	New South Wales
Australia	Local Institution - 0064	Camberwell	Victoria
Australia	Local Institution - 0065	Geelong	Victoria
Australia	Local Institution - 0105	Ivanhoe	Victoria
Australia	Local Institution - 0063	Maroochydore	Queensland
Australia	Local Institution - 0062	Paramatta	New South Wales
Australia	Local Institution - 0102	Woodville South	South Australia
Czechia	Local Institution - 0028	Brno
Czechia	Local Institution - 0025	Praha 2
France	Local Institution - 0001	Montpellier
France	Local Institution - 0047	Rouen
France	Local Institution - 0035	Strasbourg
France	Local Institution - 0002	Toulouse
Germany	Local Institution - 0059	Berlin
Germany	Local Institution - 0055	Bonn
Germany	Local Institution - 0091	Freiburg
Germany	Local Institution - 0053	Hamburg
Germany	Local Institution - 0056	Planegg
Italy	POLICLINICO "G. RODOLICO"-Rheumatology	Catania
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Hospital Santa Maria della Misericordia in Perugia-Unit of Rheumatology, Department of Medicine and	Perugia
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore	Roma
Japan	Local Institution - 0090	Kawagoe-shi	Saitama
Japan	Local Institution - 0079	Kitakyushu	Fukuoka
Japan	Local Institution - 0093	Nagoya	Aichi
Japan	Local Institution - 0110	Sapporo	Hokkaido
Japan	Local Institution - 0112	Sasebo	Nagasaki
Japan	Local Institution - 0046	Sendai-shi	Miyagi
Japan	Local Institution - 0010	Tokyo
Japan	Local Institution - 0089	Tokyo
Mexico	Local Institution - 0006	Cdmx	Distrito Federal
Mexico	Local Institution - 0009	Chihuahua
Mexico	Local Institution - 0017	Guadalajara	Jalisco
Mexico	Local Institution - 0117	Guadalajara	Jalisco
Mexico	Local Institution - 0005	Mérida	Yucatán
Mexico	Local Institution - 0008	Mexico City	Distrito Federal
Mexico	Local Institution - 0118	San Luis Potosí	SAN LUIS Potosi
Poland	Local Institution - 0124	Bydgoszcz
Poland	Local Institution - 0019	Elblag
Poland	Local Institution - 0020	Torun	Kujawsko-pomorskie
Spain	Local Institution - 0004	A Coruña
Spain	Local Institution - 0003	Madrid
Spain	Local Institution - 0085	Santander
Switzerland	Local Institution - 0049	Basel
Switzerland	Local Institution - 0052	St. Gallen
Taiwan	Local Institution - 0098	Kaohsiung Niao Sung Dist
Taiwan	Local Institution - 0104	New Taipei City
Taiwan	Local Institution - 0096	Taichung
Taiwan	Local Institution - 0095	Taichung City
Taiwan	Local Institution - 0120	Tainan
United Kingdom	Local Institution - 0111	Cannock	Staffordshire
United Kingdom	Local Institution - 0060	Hull
United Kingdom	Local Institution - 0114	London
United States	Local Institution - 0041	Aurora	Colorado
United States	NYU Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York
United States	Local Institution - 0058	Cumberland	Maryland
United States	Local Institution - 0044	Dallas	Texas
United States	Local Institution - 0031	Duncansville	Pennsylvania
United States	Local Institution - 0084	Eagan	Minnesota
United States	Local Institution - 0040	Freehold	New Jersey
United States	Local Institution - 0036	Fullerton	California
United States	Local Institution - 0038	Hagerstown	Maryland
United States	Local Institution - 0034	Jackson	Tennessee
United States	Local Institution - 0086	Los Alamitos	California
United States	Local Institution - 0119	Milwaukee	Wisconsin
United States	Local Institution - 0127	Portland	Oregon
United States	Local Institution - 0082	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Czechia,  France,  Germany,  Italy,  Japan,  Mexico,  Poland,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of shared epitope-positive (SE+) participants meeting 50% improvement in American College of Rheumatology criteria (ACR50) response		At week 24
Secondary	Proportion of SE+ participants achieving Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) remission (DAS28-CRP < 2.6)		At week 24
Secondary	Proportion of whole study population participants meeting ACR50 response		At week 24
Secondary	Proportion of SE+ participants achieving Clinical Disease Activity Index (CDAI) remission (CDAI = 2.8)		At week 24
Secondary	Mean change from baseline in SE+ participant-reported pain by visual analog scale (VAS)		At week 24
Secondary	Proportion of SE+ subset achieving 20% improvement in American College of Rheumatology criteria (ACR20) responses		Up to 104 weeks
Secondary	Proportion of SE+ whole population achieving ACR20 responses		Up to 104 weeks
Secondary	Proportion of SE+ subset achieving 50% improvement in American College of Rheumatology criteria (ACR50) responses		Up to 104 weeks
Secondary	Proportion of SE+ whole population achieving ACR50 responses		Up to 104 weeks
Secondary	Proportion of SE+ subset achieving 70% improvement in American College of Rheumatology criteria (ACR70) responses		Up to 104 weeks
Secondary	Proportion of SE+ whole population achieving ACR70 responses		Up to 104 weeks
Secondary	Proportion of SE+ subset achieving Disease Activity Score (DAS) remission		Up to 104 weeks
Secondary	Proportion of SE+ whole population achieving DAS remission		Up to 104 weeks
Secondary	Proportion of SE+ subset achieving Clinical Disease Activity Index (CDAI) remission		Up to 104 weeks
Secondary	Proportion of SE+ whole population achieving CDAI remission		Up to 104 weeks
Secondary	Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Single-blind Treatment Period (SBTP)		Up to 104 weeks
Secondary	Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Open-label Treatment Period (OLTP)		Up to 104 weeks
Secondary	Proportion of SE+ whole population achieving SDAI remission over the SBTP		Up to 104 weeks
Secondary	Proportion of SE+ whole population achieving SDAI remission over the OLTP		Up to 104 weeks
Secondary	Mean changes from baseline in DAS28-CRP		Up to 104 weeks
Secondary	Mean changes from baseline in CDAI		Up to 104 weeks
Secondary	Mean changes from baseline in SDAI over the SBTP		Up to 104 weeks
Secondary	Mean changes from baseline in SDAI over the OLTP		Up to 104 weeks
Secondary	Mean changes from baseline in the 7 ACR core components over the SBTP		Up to 104 weeks
Secondary	Mean changes from baseline in the 7 ACR core components over the OLTP		Up to 104 weeks
Secondary	Mean change from baseline in 36-item Short Form Survey (SF-36) in SE+ subset at week 24 and week 104		Up to 104 weeks
Secondary	Mean change from baseline in SF-36 in SE+ whole population at week 24 and week 104		Up to 104 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting