TerminatedPhase 2

Safety and Efficacy of BAF312 in Dermatomyositis

Stopped: The study was terminated prematurely after an interim analysis for futility. The study did not provide any evidence for efficacy of BAF312 in dermatomyositis.

United States, Czechia, Japan17 participantsStarted 2013-08-25

Plain-language summary

This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score

Timeframe: Baseline, 6 months

Trial details

NCT IDNCT02029274

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02-17

Results submitted2016-11-15

View on ClinicalTrials.gov More Active Dermatomyositis trials