Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
