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Efficacy and Tolerability of BAF312 in Patients With Polymyositis

NCT01801917 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-01-05

Study results available
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Summary

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).

Conditions

  • Polymyositis

Interventions

DRUG

Placebo

Matching placebo tablet for oral administration

DRUG

BAF312

BAF312 in 4 dosage strengths in tablet form: 0.25 mg, 0.5 mg, 1 mg, 2 mg for oral administration

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-24
Primary Completion
2016-08-05
Completion
2016-08-05
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Hungary
  • Poland
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01801917 on ClinicalTrials.gov