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

NCT04909801 | Active Not Recruiting Phase 3 Results FDA Drug

• 3 other identifiers: IM101-8632020-000350-96U1111-1247-1367
• Study Type: interventional
• Target: 338
• Locations: 14 countries
• Sites: 75

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.

Conditions

Rheumatoid Arthritis

Keywords

Abatacept; Adalimumab; BMS-188667; Humira®; Methotrexate; Orencia®; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24

  The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.

  Baseline, week 24

Secondary Outcomes (34)

• Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24

  Week 24

• Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24

  Baseline, week 24

• Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24

  Week 24

• Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24

  Baseline, week 24

• Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time

  Baseline, day 29, 57, 85, 113, 141, 169

Study Arms (2)

Arm 1: Abatacept + Methotrexate

EXPERIMENTAL

Drug: Abatacept; Drug: Methotrexate

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

EXPERIMENTAL

Drug: Abatacept; Drug: Adalimumab; Drug: Methotrexate

Interventions

Abatacept DRUG

Abatacept SC (125 mg) once weekly

Also known as: BMS-188667, Orencia®

Arm 1: Abatacept + Methotrexate; Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)

Adalimumab DRUG

Adalimumab SC (40 mg) once every 2 weeks

Also known as: Humira®

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

Methotrexate DRUG

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

Arm 1: Abatacept + Methotrexate; Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• or more joints cannot be assessed for tenderness or swelling

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (75)

Local Institution - 0036

Fullerton, California, 92835, United States

Location

Local Institution - 0086

Los Alamitos, California, 90720, United States

Location

Local Institution - 0041

Aurora, Colorado, 80045, United States

Location

Local Institution - 0058

Cumberland, Maryland, 21502, United States

Location

Local Institution - 0038

Hagerstown, Maryland, 21740, United States

Location

Local Institution - 0084

Eagan, Minnesota, 55121, United States

Location

Local Institution - 0040

Freehold, New Jersey, 07728, United States

Location

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

Local Institution - 0082

Wilmington, North Carolina, 28401, United States

Location

Local Institution - 0127

Portland, Oregon, 97239, United States

Location

Local Institution - 0031

Duncansville, Pennsylvania, 16635, United States

Location

Local Institution - 0034

Jackson, Tennessee, 38305, United States

Location

Local Institution - 0044

Dallas, Texas, 75231, United States

Location

Local Institution - 0119

Milwaukee, Wisconsin, 53217, United States

Location

Local Institution - 0012

CABA, Buenos Aires, C1015ABO, Argentina

Location

Local Institution - 0016

Quilmes, Buenos Aires, 1878, Argentina

Location

Local Institution - 0014

San Isidro, Buenos Aires, 1642, Argentina

Location

Local Institution - 0057

San Miguel de Tucumán, Tucumán Province, T4000, Argentina

Location

Local Institution - 0022

Buenos Aires, 1428, Argentina

Location

Local Institution - 0023

Buenos Aires, 1428, Argentina

Location

Local Institution - 0015

Buenos Aires, 1431, Argentina

Location

Local Institution - 0099

Córdoba, 0, Argentina

Location

Local Institution - 0072

Botany, New South Wales, 2019, Australia

Location

Local Institution - 0062

Paramatta, New South Wales, 2150, Australia

Location

Local Institution - 0063

Maroochydore, Queensland, 4558, Australia

Location

Local Institution - 0102

Woodville South, South Australia, 5011, Australia

Location

Local Institution - 0064

Camberwell, Victoria, 3124, Australia

Location

Local Institution - 0065

Geelong, Victoria, 3220, Australia

Location

Local Institution - 0105

Ivanhoe, Victoria, 3079, Australia

Location

Local Institution - 0028

Brno, 638 00, Czechia

Location

Local Institution - 0025

Prague, 12850, Czechia

Location

Local Institution - 0001

Montpellier, 34295, France

Location

Local Institution - 0047

Rouen, 76031, France

Location

Local Institution - 0035

Strasbourg, 67098, France

Location

Local Institution - 0002

Toulouse, 31059, France

Location

Local Institution - 0059

Berlin, 10117, Germany

Location

Local Institution - 0055

Bonn, 53127, Germany

Location

Local Institution - 0091

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 0053

Hamburg, 20095, Germany

Location

Local Institution - 0056

Planegg, 82152, Germany

Location

Local Institution - 0083

Catania, 95121, Italy

Location

Local Institution - 0077

Pavia, 27100, Italy

Location

Local Institution - 0078

Perugia, 06156, Italy

Location

Local Institution - 0100

Roma, 00168, Italy

Location

Local Institution - 0093

Nagoya, Aichi-ken, 457-8511, Japan

Location

Local Institution - 0079

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Local Institution - 0110

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0046

Sendai, Miyagi, 980-8574, Japan

Location

Local Institution - 0112

Sasebo, Nagasaki, 857-1195, Japan

Location

Local Institution - 0090

Kawagoe, Saitama, 350-8550, Japan

Location

Local Institution - 0089

Tokyo, 104-8560, Japan

Location

Local Institution - 0010

Tokyo, 1600035, Japan

Location

Local Institution - 0017

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution - 0117

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution - 0006

Mexico City, Mexico City, 11850, Mexico

Location

Local Institution - 0008

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution - 0118

San Luis Potosí City, San Luis Potosí, 78200, Mexico

Location

Local Institution - 0005

Mérida, Yucatán, 97070, Mexico

Location

Local Institution - 0009

Chihuahua City, 31000, Mexico

Location

Local Institution - 0020

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Local Institution - 0124

Bydgoszcz, 85-168, Poland

Location

Local Institution - 0019

Elblag, 82-300, Poland

Location

Local Institution - 0004

A Coruña, 15006, Spain

Location

Local Institution - 0003

Madrid, 28046, Spain

Location

Local Institution - 0085

Santander, 39008, Spain

Location

Local Institution - 0049

Basel, 4031, Switzerland

Location

Local Institution - 0052

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 0098

Kaohsiung Niao Sung Dist, 83301, Taiwan

Location

Local Institution - 0104

New Taipei City, 220, Taiwan

Location

Local Institution - 0095

Taichung, 402, Taiwan

Location

Local Institution - 0096

Taichung, 40447, Taiwan

Location

Local Institution - 0120

Tainan, 704, Taiwan

Location

Local Institution - 0111

Cannock, Staffordshire, WS11 5XY, United Kingdom

Location

Local Institution - 0060

Hull, HU3 2JZ, United Kingdom

Location

Local Institution - 0114

London, SE1 9RT, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept; Adalimumab; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Immunoproteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 2, 2021
• Study Start: September 15, 2021
• Primary Completion: June 14, 2023
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 19, 2025
• Results First Posted: October 15, 2024

Record last verified: 2025-02

Locations

JP (8); ME (7); PL (3); ES (3); FR (4); CH (2); IT (4); TW (5); GB (3); CZ (2); AU (7); DE (5); US (14); AR (8)