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
Study Details
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 | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm 1: Abatacept + Methotrexate
|
Drug: Abatacept
Abatacept SC (125 mg) once weekly
Other Names:
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
Other Names:
Drug: Adalimumab
Adalimumab SC (40 mg) once every 2 weeks
Other Names:
Drug: Methotrexate
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
|
Outcome Measures
Primary Outcome Measures
- Proportion of shared epitope-positive (SE+) participants meeting 50% improvement in American College of Rheumatology criteria (ACR50) response [At week 24]
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) [At week 24]
- Proportion of whole study population participants meeting ACR50 response [At week 24]
- Proportion of SE+ participants achieving Clinical Disease Activity Index (CDAI) remission (CDAI ≤ 2.8) [At week 24]
- Mean change from baseline in SE+ participant-reported pain by visual analog scale (VAS) [At week 24]
- Proportion of SE+ subset achieving 20% improvement in American College of Rheumatology criteria (ACR20) responses [Up to 104 weeks]
- Proportion of SE+ whole population achieving ACR20 responses [Up to 104 weeks]
- Proportion of SE+ subset achieving 50% improvement in American College of Rheumatology criteria (ACR50) responses [Up to 104 weeks]
- Proportion of SE+ whole population achieving ACR50 responses [Up to 104 weeks]
- Proportion of SE+ subset achieving 70% improvement in American College of Rheumatology criteria (ACR70) responses [Up to 104 weeks]
- Proportion of SE+ whole population achieving ACR70 responses [Up to 104 weeks]
- Proportion of SE+ subset achieving Disease Activity Score (DAS) remission [Up to 104 weeks]
- Proportion of SE+ whole population achieving DAS remission [Up to 104 weeks]
- Proportion of SE+ subset achieving Clinical Disease Activity Index (CDAI) remission [Up to 104 weeks]
- Proportion of SE+ whole population achieving CDAI remission [Up to 104 weeks]
- Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Single-blind Treatment Period (SBTP) [Up to 104 weeks]
- Proportion of SE+ subset achieving Simple Disease Activity Index (SDAI) remission over the Open-label Treatment Period (OLTP) [Up to 104 weeks]
- Proportion of SE+ whole population achieving SDAI remission over the SBTP [Up to 104 weeks]
- Proportion of SE+ whole population achieving SDAI remission over the OLTP [Up to 104 weeks]
- Mean changes from baseline in DAS28-CRP [Up to 104 weeks]
- Mean changes from baseline in CDAI [Up to 104 weeks]
- Mean changes from baseline in SDAI over the SBTP [Up to 104 weeks]
- Mean changes from baseline in SDAI over the OLTP [Up to 104 weeks]
- Mean changes from baseline in the 7 ACR core components over the SBTP [Up to 104 weeks]
- Mean changes from baseline in the 7 ACR core components over the OLTP [Up to 104 weeks]
- 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]
- Mean change from baseline in SF-36 in SE+ whole population at week 24 and week 104 [Up to 104 weeks]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | St Joseph Heritage Healthcare-Rheumatology | Fullerton | California | United States | 92835 |
2 | Valerius Med Group & Res Ctr Of Greater Long Beach, Inc. | Los Alamitos | California | United States | 90720 |
3 | Barbara Davis Center for Childhood Diabetes-Rheumatology | Aurora | Colorado | United States | 80045 |
4 | Klein And Associates, M.D., Pa | Cumberland | Maryland | United States | 21502 |
5 | Klein & Associates, M.D., P.A. | Hagerstown | Maryland | United States | 21740 |
6 | Local Institution | Saint Louis | Missouri | United States | 63141 |
7 | Local Institution | Lincoln | Nebraska | United States | 68516 |
8 | Local Institution | Freehold | New Jersey | United States | 07728 |
9 | Carolina Arthritis Associates | Wilmington | North Carolina | United States | 28401 |
10 | Altoona Center For Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
11 | West Tennessee Research Institute | Jackson | Tennessee | United States | 38305 |
12 | Metroplex Clinical Research Center | Dallas | Texas | United States | 75231 |
13 | Local Institution | Glendale | Wisconsin | United States | 53217 |
14 | Local Institution | La Plata | Buenos Aires | Argentina | 1900 |
15 | Local Institution - 0016 | Quilmes | Buenos Aires | Argentina | 1878 |
16 | Local Institution - 0014 | San Isidro | Buenos Aires | Argentina | 1642 |
17 | Local Institution - 0012 | Caba | Distrito Federal | Argentina | C1015 |
18 | Local Institution | DQG | Distrito Federal | Argentina | C1428 |
19 | Local Institution - 0057 | San Miguel de Tucumán | Tucuman | Argentina | T4000 |
20 | Local Institution - 0023 | Buenos Aires | Argentina | 1428 | |
21 | Local Institution - 0015 | Buenos Aires | Argentina | 1431 | |
22 | Local Institution - 0099 | Cordoba | Argentina | 0 | |
23 | Local Institution | Botany | New South Wales | Australia | 2019 |
24 | Local Institution - 0062 | Paramatta | New South Wales | Australia | 2150 |
25 | Local Institution | Maroochydore | Queensland | Australia | 4558 |
26 | Local Institution - 0102 | Woodville South | South Australia | Australia | 5001 |
27 | Local Institution - 0064 | Camberwell | Victoria | Australia | 3124 |
28 | Local Institution - 0065 | Geelong | Victoria | Australia | 3220 |
29 | Local Institution - 0105 | Ivanhoe | Victoria | Australia | 3079 |
30 | Local Institution - 0028 | Brno | Czechia | 638 00 | |
31 | Local Institution - 0025 | Praha 2 | Czechia | 12850 | |
32 | Local Institution - 0001 | Montpellier | France | 34295 | |
33 | Local Institution - 0047 | Rouen | France | 76031 | |
34 | CHU Strasbourg-Hautepierre-Service de Rhumatologie | Strasbourg | France | 67098 | |
35 | Local Institution - 0002 | Toulouse | France | 31059 | |
36 | Local Institution - 0059 | Berlin | Germany | 10117 | |
37 | Local Institution | Bonn | Germany | 53127 | |
38 | Local Institution - 0091 | Freiburg | Germany | 79106 | |
39 | Local Institution - 0053 | Hamburg | Germany | 20095 | |
40 | Local Institution - 0056 | Planegg | Germany | 82152 | |
41 | Local Institution - 0083 | Catania | Italy | 95121 | |
42 | Local Institution - 0077 | Pavia | Italy | 27100 | |
43 | Local Institution - 0078 | Perugia | Italy | 06156 | |
44 | Local Institution - 0100 | Roma | Italy | 00168 | |
45 | Local Institution - 0079 | Kitakyushu | Fukuoka | Japan | 807-8556 |
46 | Local Institution - 0110 | Sapporo | Hokkaido | Japan | 0608648 |
47 | Local Institution - 0046 | Sendai-shi | Miyagi | Japan | 980-8574 |
48 | Local Institution - 0112 | Sasebo | Nagasaki | Japan | 857-1195 |
49 | Local Institution - 0090 | Kawagoe-shi | Saitama | Japan | 3508550 |
50 | Local Institution | Shinjuku-ku | Tokyo | Japan | 1600016 |
51 | Local Institution - 0093 | Aichi | Japan | 457-8511 | |
52 | Local Institution - 0089 | Tokyo | Japan | 104-8560 | |
53 | Local Institution - 0006 | Cdmx | Distrito Federal | Mexico | 11850 |
54 | Local Institution - 0008 | Mexico City | Distrito Federal | Mexico | 14080 |
55 | Local Institution - 0017 | Guadalajara | Jalisco | Mexico | 44650 |
56 | Local Institution - 0117 | Guadalajara | Jalisco | Mexico | 44650 |
57 | Local Institution - 0118 | San Luis Potosí | SAN LUIS Potosi | Mexico | 78200 |
58 | Local Institution - 0005 | Mérida | Yucatán | Mexico | 97070 |
59 | Local Institution - 0009 | Chihuahua | Mexico | 31000 | |
60 | Local Institution - 0124 | Bydgoszcz | Poland | 85-168 | |
61 | Local Institution | Bydgoszcz | Poland | 85-168 | |
62 | Local Institution - 0019 | Elblag | Poland | 82-300 | |
63 | Local Institution - 0020 | Torun | Poland | 87-100 | |
64 | Local Institution - 0004 | A Coruña | Spain | 15006 | |
65 | Local Institution - 0003 | Madrid | Spain | 28046 | |
66 | Local Institution - 0085 | Santander | Spain | 39008 | |
67 | Local Institution - 0049 | Basel | Switzerland | 4031 | |
68 | Local Institution - 0052 | St. Gallen | Switzerland | 9007 | |
69 | Local Institution - 0098 | Kaohsiung Niao Sung Dist | Taiwan | 83301 | |
70 | Local Institution - 0104 | New Taipei City | Taiwan | 220 | |
71 | Local Institution - 0095 | Taichung City | Taiwan | 402 | |
72 | Local Institution - 0096 | Taichung | Taiwan | 40447 | |
73 | Local Institution - 0120 | Tainan | Taiwan | 704 | |
74 | Local Institution | Tainan | Taiwan | 71004 | |
75 | Local Institution - 0111 | Cannock | Staffordshire | United Kingdom | WS11 5XY |
76 | Local Institution | Greater London, London | United Kingdom | SE1 1UL | |
77 | Local Institution - 0060 | Hull | United Kingdom | HU3 2JZ |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- FDA Safety Alerts and Recalls
- Investigator Inquiry Form
Publications
None provided.- IM101-863
- 2020-000350-96
- U1111-1247-1367