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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

Primary Purpose

Rheumatoid Arthritis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abatacept
Adalimumab
Methotrexate
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Abatacept, Adalimumab, BMS-188667, Humira®, Methotrexate, Orencia®, Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0036
  • Local Institution - 0086
  • Local Institution - 0041
  • Local Institution - 0058
  • Local Institution - 0038
  • Local Institution - 0084
  • Local Institution
  • Local Institution - 0040
  • Local Institution - 0082
  • Local Institution - 0127
  • Local Institution - 0031
  • Local Institution - 0034
  • Local Institution - 0044
  • Local Institution - 0119
  • Local Institution - 0012
  • Local Institution - 0016
  • Local Institution - 0014
  • Local Institution
  • Local Institution - 0057
  • Local Institution - 0023
  • Local Institution - 0015
  • Local Institution - 0099
  • Local Institution - 0072
  • Local Institution - 0062
  • Local Institution - 0063
  • Local Institution - 0102
  • Local Institution - 0064
  • Local Institution - 0065
  • Local Institution - 0105
  • Local Institution - 0028
  • Local Institution - 0025
  • Local Institution - 0001
  • Local Institution - 0047
  • Local Institution - 0035
  • Local Institution - 0002
  • Local Institution - 0059
  • Local Institution - 0055
  • Local Institution - 0091
  • Local Institution - 0053
  • Local Institution - 0056
  • POLICLINICO "G. RODOLICO"-Rheumatology
  • Fondazione IRCCS Policlinico San Matteo
  • Hospital Santa Maria della Misericordia in Perugia-Unit of Rheumatology, Department of Medicine and
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
  • Local Institution - 0093
  • Local Institution - 0079
  • Local Institution - 0110
  • Local Institution - 0046
  • Local Institution - 0112
  • Local Institution - 0090
  • Local Institution - 0089
  • Local Institution - 0010
  • Local Institution - 0006
  • Local Institution - 0008
  • Local Institution - 0017
  • Local Institution - 0117
  • Local Institution - 0118
  • Local Institution - 0005
  • Local Institution - 0009
  • Local Institution - 0020
  • Local Institution - 0124
  • Local Institution
  • Local Institution - 0019
  • Local Institution - 0004
  • Local Institution - 0003
  • Local Institution - 0085
  • Local Institution - 0049
  • Local Institution - 0052
  • Local Institution - 0098
  • Local Institution - 0104
  • Local Institution - 0095
  • Local Institution - 0096
  • Local Institution - 0120
  • Local Institution - 0111
  • Local Institution - 0060
  • Local Institution - 0114

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Abatacept + Methotrexate

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

Arm Description

Outcomes

Primary Outcome Measures

Proportion of shared epitope-positive (SE+) participants meeting 50% improvement in American College of Rheumatology criteria (ACR50) response

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2021
Last Updated
September 1, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04909801
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 14, 2023 (Actual)
Study Completion Date
September 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Abatacept, Adalimumab, BMS-188667, Humira®, Methotrexate, Orencia®, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Abatacept + Methotrexate
Arm Type
Experimental
Arm Title
Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
BMS-188667, Orencia®
Intervention Description
Abatacept SC (125 mg) once weekly
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira®
Intervention Description
Adalimumab SC (40 mg) once every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Proportion of whole study population participants meeting ACR50 response
Time Frame
At week 24
Title
Proportion of SE+ participants achieving Clinical Disease Activity Index (CDAI) remission (CDAI ≤ 2.8)
Time Frame
At week 24
Title
Mean change from baseline in SE+ participant-reported pain by visual analog scale (VAS)
Time Frame
At week 24
Title
Proportion of SE+ subset achieving 20% improvement in American College of Rheumatology criteria (ACR20) responses
Time Frame
Up to 104 weeks
Title
Proportion of SE+ whole population achieving ACR20 responses
Time Frame
Up to 104 weeks
Title
Proportion of SE+ subset achieving 50% improvement in American College of Rheumatology criteria (ACR50) responses
Time Frame
Up to 104 weeks
Title
Proportion of SE+ whole population achieving ACR50 responses
Time Frame
Up to 104 weeks
Title
Proportion of SE+ subset achieving 70% improvement in American College of Rheumatology criteria (ACR70) responses
Time Frame
Up to 104 weeks
Title
Proportion of SE+ whole population achieving ACR70 responses
Time Frame
Up to 104 weeks
Title
Proportion of SE+ subset achieving Disease Activity Score (DAS) remission
Time Frame
Up to 104 weeks
Title
Proportion of SE+ whole population achieving DAS remission
Time Frame
Up to 104 weeks
Title
Proportion of SE+ subset achieving Clinical Disease Activity Index (CDAI) remission
Time Frame
Up to 104 weeks
Title
Proportion of SE+ whole population achieving CDAI remission
Time Frame
Up to 104 weeks
Title
Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Single-blind Treatment Period (SBTP)
Time Frame
Up to 104 weeks
Title
Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Open-label Treatment Period (OLTP)
Time Frame
Up to 104 weeks
Title
Proportion of SE+ whole population achieving SDAI remission over the SBTP
Time Frame
Up to 104 weeks
Title
Proportion of SE+ whole population achieving SDAI remission over the OLTP
Time Frame
Up to 104 weeks
Title
Mean changes from baseline in DAS28-CRP
Time Frame
Up to 104 weeks
Title
Mean changes from baseline in CDAI
Time Frame
Up to 104 weeks
Title
Mean changes from baseline in SDAI over the SBTP
Time Frame
Up to 104 weeks
Title
Mean changes from baseline in SDAI over the OLTP
Time Frame
Up to 104 weeks
Title
Mean changes from baseline in the 7 ACR core components over the SBTP
Time Frame
Up to 104 weeks
Title
Mean changes from baseline in the 7 ACR core components over the OLTP
Time Frame
Up to 104 weeks
Title
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
Title
Mean change from baseline in SF-36 in SE+ whole population at week 24 and week 104
Time Frame
Up to 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0036
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Local Institution - 0086
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Local Institution - 0041
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0058
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Local Institution - 0038
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Local Institution - 0084
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Local Institution
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Local Institution - 0040
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Local Institution - 0082
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Local Institution - 0127
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution - 0031
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Local Institution - 0034
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Local Institution - 0044
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Local Institution - 0119
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Local Institution - 0012
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Local Institution - 0016
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
1878
Country
Argentina
Facility Name
Local Institution - 0014
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Local Institution
City
DQG
State/Province
Distrito Federal
ZIP/Postal Code
C1428
Country
Argentina
Facility Name
Local Institution - 0057
City
San Miguel de Tucumán
State/Province
Tucuman
ZIP/Postal Code
T4000
Country
Argentina
Facility Name
Local Institution - 0023
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Local Institution - 0015
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Local Institution - 0099
City
Cordoba
ZIP/Postal Code
0
Country
Argentina
Facility Name
Local Institution - 0072
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Facility Name
Local Institution - 0062
City
Paramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Local Institution - 0063
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Local Institution - 0102
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5001
Country
Australia
Facility Name
Local Institution - 0064
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Local Institution - 0065
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Local Institution - 0105
City
Ivanhoe
State/Province
Victoria
ZIP/Postal Code
3079
Country
Australia
Facility Name
Local Institution - 0028
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Local Institution - 0025
City
Praha 2
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Local Institution - 0001
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution - 0047
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Local Institution - 0035
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Local Institution - 0002
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0059
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution - 0055
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Local Institution - 0091
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution - 0053
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Local Institution - 0056
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Facility Name
POLICLINICO "G. RODOLICO"-Rheumatology
City
Catania
ZIP/Postal Code
95121
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Hospital Santa Maria della Misericordia in Perugia-Unit of Rheumatology, Department of Medicine and
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution - 0093
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Local Institution - 0079
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Local Institution - 0110
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution - 0046
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Local Institution - 0112
City
Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Local Institution - 0090
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
3508550
Country
Japan
Facility Name
Local Institution - 0089
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Local Institution - 0010
City
Tokyo
ZIP/Postal Code
1600035
Country
Japan
Facility Name
Local Institution - 0006
City
Cdmx
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Local Institution - 0008
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution - 0017
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Local Institution - 0117
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Local Institution - 0118
City
San Luis Potosí
State/Province
SAN LUIS Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Local Institution - 0005
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Local Institution - 0009
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Local Institution - 0020
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Local Institution - 0124
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution - 0019
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution - 0004
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution - 0003
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution - 0085
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0049
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution - 0052
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Local Institution - 0098
City
Kaohsiung Niao Sung Dist
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Local Institution - 0104
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Local Institution - 0095
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Local Institution - 0096
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution - 0120
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution - 0111
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
Facility Name
Local Institution - 0060
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Local Institution - 0114
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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