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Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis

NCT02043548 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-10-30

Study results available
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Summary

The purpose of this multi-center pilot study is to determine if the drug tocilizumab (Actemra) is effective in the treatment of patients with refractory adult polymyositis (PM) and dermatomyositis (DM).

Conditions

  • Dermatomyositis
  • Polymyositis

Interventions

DRUG

tocilizumab

given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).

DRUG

placebo

given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Chester Oddis

    lead OTHER

Principal Investigators

  • Chester V. Oddis, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2019-07-30
Completion
2019-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02043548 on ClinicalTrials.gov