Rheumatoid Arthritis MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Current Sp
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 340 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority in efficacy of abatacept compared with adalimumab, both on background MTX, in achieving clinical response (ACR50) at Week 24, in early, seropositive (RF+ and ACPA+) RA patients with the SE HLA Class II risk alleles (ie, SE+).;Secondary Objective: To compare the efficacy of abatacept with adalimumab, both on background MTX in achieving: - clinical remission criteria (DAS28-CRP remission) at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+). - clinical response (ACR50) at Week 24 in the whole study population of early, seropositive RA patients. - clinical remission criteria (CDAI remission) at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+). - improvement in pain at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+). To determine: - the efficacy over time by treatment in early, seropositive RA patients (SE+ subset and whole population). - the improvement in health-related quality of life over time by treatment in early, seropositive RA patients (SE+ subset and whole population).;Primary end point(s): Proportion of SE+ participants meeting ACR50 response at Week 24;Timepoint(s) of evaluation of this end point: At Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of SE+ participants achieving DAS28-CRP remission (DAS28-CRP < 2.6) at Week 24 2. Proportion of whole study population participants meeting ACR50 response at Week 24 3. Proportion of SE+ participants achieving CDAI remission (CDAI = 2.8) at Week 24 4. Mean change from baseline in SE+ participant-reported pain (VAS) at Week 24 5. Proportion of SE+ subset and whole population achieving ACR20/50/70 responses, DAS remission, CDAI remission, SDAI remission over the SBTP and OLTP; mean changes from baseline in DAS28-CRP, CDAI, SDAI over the SBTP and OLTP; mean changes from baseline in the 7 ACR core components over the SBTP and OLTP 6. Mean change from baseline in SF-36 in SE+ subset and whole population at Week 24 and Week 104 (4 physical and 4 mental subscales and the physical component and mental component summary);Timepoint(s) of evaluation of this end point: 1-4. At Week 24 5. Over the SBTP and OLTP 6. At Week 24 and Week 104 | — |
Countries
Argentina, Australia, Czechia, Czech Republic, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed