Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02638948 | Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis | PHASE2 | COMPLETED | 508 | — | — | Feb 16, 2016 | May 3, 2018 | May 28, 2019 | 104 | United States, Argentina +15 |
| NCT02762123 | A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates | PHASE1 | COMPLETED | 28 | — | — | May 1, 2016 | Aug 1, 2016 | Sep 16, 2016 | 1 | United States |
ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)\*100
ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)\*100
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo + Methotrexate dose as specified |
| Dose Level 1 | EXPERIMENTAL | BMS-986142 at dose level 1+ Methotrexate as specified |
| Dose Level 2 | EXPERIMENTAL | BMS-986142 at dose level 2 + Methotrexate as specified |
| Cohort 1 (BMS-986142: 200 mg) | EXPERIMENTAL | 200mg BMS-986142 administered orally once daily on specified days. |
| Cohort 2 (BMS-986142: 350 mg) | EXPERIMENTAL | 350mg BMS-986142 administered orally once daily on specified days. |
| Name | Type | Description |
|---|---|---|
| BMS-986142 | DRUG | BMS986142 specific dose on specific days |
| Placebo | DRUG | Placebo of BMS-986142 specific dose on specific days |
| Methotrexate | DRUG | Methotrexate specific dose on specific days |
| BMS-986142 200mg | DRUG | - |
| BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin) | DRUG | - |
| BMS-986142 350mg | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Male and female age 18 and above * Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III * ...