Clinical trial NCT04909801: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Abatacept
Adalimumab
BMS-188667
Humira®
Methotrexate
Orencia®
Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
timeFrame: Baseline, week 24
Secondary outcomes:
measure: Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24
timeFrame: Week 24
measure: Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
timeFrame: Baseline, week 24
measure: Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24
timeFrame: Week 24
measure: Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24
timeFrame: Baseline, week 24
measure: Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants
timeFrame: Baseline, day 29, 57, 85, 113, 141, 169
measure: Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants
timeFrame: Up to week 24
measure: Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants
timeFrame: Up to week 24
measure: Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants
timeFrame: Up to week 24
measure: Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants
timeFrame: Up to week 24
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Local Institution - 0036
state: California
city: Los Alamitos
country: United States
facility: Local Institution - 0086
state: California
city: Aurora
country: United States
facility: Local Institution - 0041
state: Colorado
city: Cumberland
country: United States
facility: Local Institution - 0058
state: Maryland
city: Hagerstown
country: United States
facility: Local Institution - 0038
state: Maryland
city: Eagan
country: United States
facility: Local Institution - 0084
state: Minnesota
city: Freehold
country: United States
facility: Local Institution - 0040
state: New Jersey
city: Brooklyn
country: United States
facility: NYU Langone Ambulatory Care Brooklyn Heights
state: New York
city: Wilmington
country: United States
facility: Local Institution - 0082
state: North Carolina
city: Portland
country: United States
facility: Local Institution - 0127
state: Oregon
city: Duncansville
country: United States
facility: Local Institution - 0031
state: Pennsylvania
city: Jackson
country: United States
facility: Local Institution - 0034
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0044
state: Texas
city: Milwaukee
country: United States
facility: Local Institution - 0119
state: Wisconsin
city: Caba
country: Argentina
facility: Local Institution - 0012
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Local Institution - 0016
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Local Institution - 0014
state: Buenos Aires
city: San Miguel de Tucumán
country: Argentina
facility: Local Institution - 0057
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution - 0022
city: Buenos Aires
country: Argentina
facility: Local Institution - 0023
city: Buenos Aires
country: Argentina
facility: Local Institution - 0015
city: Cordoba
country: Argentina
facility: Local Institution - 0099
city: Botany
country: Australia
facility: Local Institution - 0072
state: New South Wales
city: Paramatta
country: Australia
facility: Local Institution - 0062
state: New South Wales
city: Maroochydore
country: Australia
facility: Local Institution - 0063
state: Queensland
city: Woodville South
country: Australia
facility: Local Institution - 0102
state: South Australia
city: Camberwell
country: Australia
facility: Local Institution - 0064
state: Victoria
city: Geelong
country: Australia
facility: Local Institution - 0065
state: Victoria
city: Ivanhoe
country: Australia
facility: Local Institution - 0105
state: Victoria
city: Brno
country: Czechia
facility: Local Institution - 0028
city: Praha 2
country: Czechia
facility: Local Institution - 0025
city: Montpellier
country: France
facility: Local Institution - 0001
city: Rouen
country: France
facility: Local Institution - 0047
city: Strasbourg
country: France
facility: Local Institution - 0035
city: Toulouse
country: France
facility: Local Institution - 0002
city: Berlin
country: Germany
facility: Local Institution - 0059
city: Bonn
country: Germany
facility: Local Institution - 0055
city: Freiburg
country: Germany
facility: Local Institution - 0091
city: Hamburg
country: Germany
facility: Local Institution - 0053
city: Planegg
country: Germany
facility: Local Institution - 0056
city: Catania
country: Italy
facility: Local Institution - 0083
city: Pavia
country: Italy
facility: Local Institution - 0077
city: Perugia
country: Italy
facility: Local Institution - 0078
city: Roma
country: Italy
facility: Local Institution - 0100
city: Nagoya
country: Japan
facility: Local Institution - 0093
state: Aichi
city: Kitakyushu
country: Japan
facility: Local Institution - 0079
state: Fukuoka
city: Sapporo
country: Japan
facility: Local Institution - 0110
state: Hokkaido
city: Sendai-shi
country: Japan
facility: Local Institution - 0046
state: Miyagi
city: Sasebo
country: Japan
facility: Local Institution - 0112
state: Nagasaki
city: Kawagoe
country: Japan
facility: Local Institution - 0090
state: Saitama
city: Tokyo
country: Japan
facility: Local Institution - 0089
city: Tokyo
country: Japan
facility: Local Institution - 0010
city: Cdmx
country: Mexico
facility: Local Institution - 0006
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution - 0008
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution - 0017
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution - 0117
state: Jalisco
city: San Luis Potosí
country: Mexico
facility: Local Institution - 0118
state: SAN LUIS Potosi
city: Mérida
country: Mexico
facility: Local Institution - 0005
state: Yucatán
city: Chihuahua
country: Mexico
facility: Local Institution - 0009
city: Torun
country: Poland
facility: Local Institution - 0020
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Local Institution - 0124
city: Elblag
country: Poland
facility: Local Institution - 0019
city: A Coruña
country: Spain
facility: Local Institution - 0004
city: Madrid
country: Spain
facility: Local Institution - 0003
city: Santander
country: Spain
facility: Local Institution - 0085
city: Basel
country: Switzerland
facility: Local Institution - 0049
city: St. Gallen
country: Switzerland
facility: Local Institution - 0052
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Local Institution - 0098
city: New Taipei City
country: Taiwan
facility: Local Institution - 0104
city: Taichung City
country: Taiwan
facility: Local Institution - 0095
city: Taichung
country: Taiwan
facility: Local Institution - 0096
city: Tainan
country: Taiwan
facility: Local Institution - 0120
city: Cannock
country: United Kingdom
facility: Local Institution - 0111
state: Staffordshire
city: Hull
country: United Kingdom
facility: Local Institution - 0060
city: London
country: United Kingdom
facility: Local Institution - 0114
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: