EUCTR2012-002859-42-BEActive, not recruitingPhase 1
A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-definite or probable for polymyositis at least three months before
- •- active active myositis as defined by elevated CK levels, or other
- •enzymes, or MRI/biopsy if enzymes are normal, and persisting muscle
- •- stable dose of corticosteroid for at least 2 weeks prior to Baseline and
- •should not have received a high dose in the last 8 weeks prior to study
- •- patients treated with methotrexate must have been on a stable dose
- •for at least 6 weeks prior to Baseline.
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
Exclusion Criteria
- •- Patients with overlap polymyositis, late-stage polymyositis, or other
- •types of myositis.
- •- Preexisting severe cardiac or pulmonary involvement, malignancy of
- •any organ system or significant eye diseases.
- •- Uncontrolled diabetes mellitus or diabetes complicated with organ
- •involvement.
- •- Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitislcerative colitisMedDRA version: 14.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2010-019970-33-BEovartis Services AG72
Active, not recruiting
Not Applicable
A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitislcerative colitisMedDRA version: 12.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2010-019970-33-SEovartis Services AG72
Active, not recruiting
Not Applicable
A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositisEUCTR2008-006311-21-CZovartis Pharma Services AG45
Active, not recruiting
Not Applicable
A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitislcerative colitisMedDRA version: 12.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2010-019970-33-GBovartis Services AG80
Active, not recruiting
Phase 1
Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositisPolymyositisMedDRA version: 19.0Level: PTClassification code 10036102Term: PolymyositisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2012-002859-42-CZovartis Pharma Services AG45