Safety and Efficacy of BAF312 in Dermatomyositis

Launched by NOVARTIS PHARMACEUTICALS · Jan 6, 2014

Keywords

ClinConnect Summary

The study was prematurely terminated based on the results of an interim analysis where BAF312 did not demonstrate superior efficacy over placebo and a dose-response relationship was not observed. There were no safety concerns. Approximately 56 participants were planned to be randomized. A total of 17 participants were enrolled and randomized by the time the study was terminated.

Gender

ALL

Eligibility criteria

• Key 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 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
• • Key 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