EUCTR2012-005772-34-ITActive, not recruitingPhase 1
A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease
Institut de Recherches Internationales Servier (IRIS)0 sites40 target enrollmentStarted: May 22, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Active polymyositis or dermatomyositis intolerant or resistant or dependent to systemic oral corticosteroids,
- •- Disease diagnosis duration =6 years,
- •- With a stable background treatment of oral corticosteroid if any and / or a stable dose of immunosuppressive agent if any.
- •- Male or female, age = 18 (or legal age of majority in the country),
- •- Weight = 40 kg and = 125 kg at selection,
- •- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •- Juvenile dermatomyositis, drug induced myositis, severity criteria such as severe cardiovascular or pulmonary involvement or myositis damage, necrotizing myopathy, inclusion body myositis, cancer- associated myositis or DM diagnosed for less than 1 year,
- •- Impossibility to perform muscle biopsy for PM patients (if required),
- •- Non-ambulatory patients,
- •- Fibromyalgia of type I,
- •- Joint disease or other musculoskeletal condition,
- •- Active TB disease,
- •- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
- •- History of malignancy within 5 years prior to selection,
- •- Known immunodeficiency,
- •- Infectious disease,
- •- Pregnancy, breastfeeding or possibility to become pregnant during the study
Investigators
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