Rheumatoid Arthritis
Conditions
Interventions
investigational material(s)
Generic name etc : BMS-986142
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investig
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III Have an inadequate response to methotrexate In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count) Have hsCRP of not less than 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR not less than 28 mm/hr Willing to use effective birth control for the entire length of the study
Exclusion criteria
Exclusion criteria: Diagnosed with juvenile Rheumatoid Arthritis Have been treated with other biologic treatment than a TNF inhibitor Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents) Have other autoimmune disease other than RA like lupus, multiple sclerosis Have significant concurrent medical condition at the time of screening or baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Proportion of subjects who achieve ACR70 response rate [ Time Frame: At week 12 ] [ Designated as safety issue: No ] Proportion of subjects who achieve ACR20 response rate [ Time Frame: At week 12 ] [ Designated as safety issue: No | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics Proportion of subjects who achieve ACR20 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ] Proportion of subjects who achieve ACR50 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ] Proportion of subjects who achieve ACR70 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ] Proportion of subjects who achieve DAS28- C-reactive protein (CRP) less than 2.6 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ] Proportion of subjects who achieve DAS28- erythrocyte sedimentation rate (ESR) less than 2.6 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ] Proportion of subjects who achieve clinical disease activity index (CDAI) less than or equal to 2.8 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ] Proportion of subjects who achieve simplified disease index (SDAI) less than or equal to 3.3 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ] Proportion of subjects who achieve Boolean Remission [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ] Change from baseline in DAS28-CRP score [ Time Frame: Upto week 12 ] [ Designated as safety issue: No ] Change from baseline in DAS28-ESR score [ Time Frame: Upto week 12 ] [ Designated as safety issue: No ] Change from baseline in CDAI score [ Time Frame: Upto week 12 ] [ Designated as safety issue: No ] Change from baseline in SDAI score [ Time Frame: Upto week 12 ] [ Designated as safety issue: No ] Change from baseline in rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS) scores of synovitis [ Time Frame: Upto week 12 ] [ Designated as safety issue: No ] Change from baseline in RAMRIS scores of osteitis (bone marrow edema) [ Time Frame: Upto week 12 ] [ Designated as safety issue: No ] Change from baseline in RAMRIS scores of bone erosion [ Time Frame: Upto week 12 ] [ Designated as safety issue: No ] Change from baseli | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed