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NCT01148810 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01148810 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 18 participants.
The verdict
NCT01148810, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects received BAF312 treatment.
Interventions
- DRUG Placebo
- DRUG BAF312
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-06-15 |
| Est. Completion | 2012-06-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01148810
The ClinicalTrials.gov registry entry for NCT01148810 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01148810 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01148810 about?
NCT01148810 is a clinical study titled "Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis". This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12 week, randomized, placebo c...
What is the current status of trial NCT01148810?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2010-06-15. Estimated completion is 2012-06-13.
What interventions are being tested in trial NCT01148810?
The interventions under investigation include: Placebo (DRUG), BAF312 (DRUG).
Who is sponsoring clinical trial NCT01148810?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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