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Belimumab in Idiopathic Inflammatory Myositis

NCT02347891 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-02-09

Study results available
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Summary

The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care. This is a multicentre double-blind, placebo-controlled trial.

Conditions

  • Myositis

Interventions

DRUG

Belimumab

Randomized phase: Week 0 - Week 40

DRUG

Placebo

Randomized phase: Week 0 - Week 40

Sponsors & Collaborators

Principal Investigators

  • Galina Marder, MD · Northwell.edu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2020-11-30
Completion
2020-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02347891 on ClinicalTrials.gov