At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 149 enrolled
Drug / intervention
Abatacept subcutaneous +1 moredrug
Likely dose
Abatacept subcutaneous—specified dose on specified days (exact dose not stated in protocol excerpt)AI-extracted
Key inclusion· 5
- ✓Confirmed diagnosis of IIM: DM with myositis-associated rash + 2/4 additional criteria; PM/ANMM/overlap/juvenile myositis ≥18y with prior muscle biopsy or positive myositis-specific autoantibody (Jo-1, PL-7, PL-12, EJ, OJ, KS, Zo, YRS, Mi-2, SRP, TIF1-γ, NXP-2, MDA5, SAE, or HMGCR).
- ✓Demonstrable muscle weakness with MMT-8 ≤135 units plus any 3 of: MMT-8 ≤125, PGA VAS ≥2 cm, SGA VAS ≥2 cm, HAQ-DI ≥0.5, muscle enzyme ≥1.3× ULN, or MDAAT extramuscular activity VAS ≥2 cm.
- ✓Demonstration of currently active IIM: active myositis-associated rash, or recent (≤3 months) biopsy/MRI/EMG showing active disease, or CK >5× ULN, or adjudication committee determination.
- ✓Active disease despite prior treatment with corticosteroids, immunosuppressants, or biologics as determined by investigator.
Key exclusion· 11
- ✕Inclusion Body Myositis (IBM) or myositis other than IIM (e.g., drug-induced myositis, PM associated with HIV).
- ✕Penicillamine or zidovudine use in past 3 months.
- ✕Rituximab within 6 months prior to randomization (requires documented circulating B cells [CD19+]) or other biologic within 3 months or IVIG/SCIG within 3 months.
- ✕Uncontrolled or rapidly progressive interstitial lung disease.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)
In Brief
A Phase 3 clinical trial evaluating Abatacept subcutaneous and Placebo for Polymyositis and 4 related conditions. Completed, enrolled 149 participants across 79 sites in 11 countries.
Detailed Summary
Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18
CountriesAustralia, Brazil, Czechia, France, Germany, Italy, Japan, Mexico, South Korea, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartMay 2017
Primary CompletionJul 2020
Study CompletionAug 2022
TodayJul 2026
First PostedNov 23, 2016
Enrollment StartMay 4, 2017
Primary CompletionJul 27, 2020
Study CompletionAug 2, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.6 years ago
Interventions
Abatacept subcutaneousdrug
Specified dose of Abatacept subcutaneous on specified days
Placebodrug
Placebo of Abatacept subcutaneous