EUCTR2018-003171-35-DEActive, not recruitingPhase 1
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- CSL Behring LLC
- Enrollment
- 126
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •male or female subjects = 18 years of age with diagnosis of at least
- •probable idiopathic inflammatory myopathies per European League
- •Against Rheumatism/American College of Rheumatology (EULAR/ACR)
- •Classification Criteria which includes confirmation of dermatomyositis
- •(DM) rash/manifestation, disease activity defined by presence of DM
- •rash / manifestation or an objective disease activity measure, and
- •disease severity defined by Physician global visual analog scale (VAS)
- •with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 = 142 or
- •CDASI total activity score = 14.
- •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 94
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
Exclusion Criteria
- •Cancer-associated myositis, evidence of active malignant disease or malignancies diagnosed within the previous 5 years, Physician Global Damage = 3, or clinically relevant improvement between Screening Visit and Baseline
Investigators
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