Polymyositis or dermatomyositis according to 2017 EULAR / ACR classification criteria
Conditions
Brief summary
Participants who have at least moderate improvement in disease activity (TIS ≥ 40) and has not met “confirmed deterioration” criteria at 2 consecutive visits
Detailed description
MMT-8 (CSM) change from baseline at week 52, Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at week 52 (yes/no), PM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52, DM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52, CDASI-activity change from baseline (DM participants only) at week 8, "MMT-8 (CSM) change from baseline at Week 52. Only PM participants will be included in the analysis.", "MMT-8 (CSM) change from baseline at Week 52 Only DM participants will be included in the analysis.", "Participants who achieve OCS dose ≤ 7.5 mg/day at Week 52 (yes/no). Only PM participants with baseline OCS dose > 7.5 mg/day at baseline will be included in the analysis.", "Participants who achieve OCS dose ≤ 7.5 mg/day at Week 52 (yes/no). Only DM participants with baseline OCS dose > 7.5 mg/day at baseline will be included in the analysis."
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants who have at least moderate improvement in disease activity (TIS ≥ 40) and has not met “confirmed deterioration” criteria at 2 consecutive visits | — |
Secondary
| Measure | Time frame |
|---|---|
| MMT-8 (CSM) change from baseline at week 52, Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at week 52 (yes/no), PM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52, DM Participants who have at least moderate improvement in disease activity (TIS ≥ 40) at week 52 and has not met “confirmed deterioration” criteria at 2 consecutive visits up to and including week 52, CDASI-activity change from baseline (DM participants only) at week 8, "MMT-8 (CSM) change from baseline at Week 52. Only PM participants will be included in the analysis.", "MMT-8 (CSM) change from baseline at Week 52 Only DM participants will be included in the analysis.", "Participants who achieve OCS dose ≤ 7.5 mg/day at Week 52 (yes/no). Only PM participants with baseline OCS dose > 7.5 mg/day at baseline will be included in the analysis.", "Participants who ac | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden