Study of efficacy and tolerability for BAF312 compared to placebo in patients with active dermatomyositis.

• Conditions: Active dermatomyositis; MedDRA version: 18.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-001799-39-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-08
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Written informed consent must be obtained before any assessment is performed.
• Patients who have been defined as definite or probable” based on the criteria of Bohan and Peter (Bohan and Peter 1975) for dermatomyositis at least 3 months before screening
• Patients must have active disease as defined by muscle weakness
• Patients must have responded inadequately to previous standard of care or have demonstrated significant toxicity or intolerance to such therapies.
• Patients may be on a stable dose of corticosteroid (up/equal to 20 mg once daily prednisone equivalent)
• Patients currently treated with oral or subcutaneous MTX must have been a stable dose of no more/equal to than 25 mg per week
• Patients currently treated with Azathioprine must have been a stable maintenance dose of no more/equal to 3 mg/kg/day
• Negative cancer screening conducted in the 12 months prior to screening visit

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

• Dermatomyositis patients having overlap myositis or any other type of myositis including paraneoplastic myositis, drug-induced myopathy, necrotizing myositis
• Preexisting severe cardiac or pulmonary conditions, 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 apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified