Efficacy and Tolerability of BAF312 in Patients With Polymyositis

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Novartis

Status and phase

Terminated
Phase 2

Conditions

Polymyositis

Treatments

Drug: Placebo
Drug: BAF312

Study type

Interventional

Funder types

Industry

Identifiers

NCT01801917
CBAF312X2205

Details and patient eligibility

About

This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic drugs).

Full description

This study was stopped prematurely due to overall slow recruitment and no evidence for efficacy in a parallel study in dermatomyositis with an assumed similar pathophysiology. With very small sample sizes per group the overall results for this study including primary and all other efficacy and PD data are inconclusive

Enrollment

14 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • "definite" or "probable" for polymyositis at least three months before Baseline
  • active disease as defined by elevated CK levels, or other enzymes, or MRI/biopsy if enzymes are normal, and persisting muscle weakness
  • stable dose of corticosteroid for at least 2 weeks prior to Baseline and should not have received a medium or high dose in the last 8 weeks prior to study entry.
  • patients treated with methotrexate must have been on a stable dose for at least 6 weeks prior to Baseline.

Exclusion criteria

  • Patients with overlap polymyositis, late-stage polymyositis, or other types of myositis.
  • Preexisting severe cardiac or pulmonary involvement, malignancy of any organ system or significant eye diseases.
  • Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.
  • Pregnant or nursing (lactating) women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

14 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
5 placebo tablets daily during non-titration phase
Treatment:
Drug: Placebo
BAF312 2mg
Experimental group
Description:
1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during non-titration phase
Treatment:
Drug: BAF312
BAF312 10 mg
Experimental group
Description:
5 tablets of BAF312 2 mg daily during non-titration phase
Treatment:
Drug: BAF312

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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