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An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

NCT01753193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2019-07-31

Study results available
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Summary

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

Conditions

  • Lupus Erythematosus, Systemic

Interventions

BIOLOGICAL

Anifrolumab

Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-03-28
Primary Completion
2018-07-18
Completion
2018-07-18

Countries

  • United States
  • Brazil
  • Bulgaria
  • Colombia
  • Czechia
  • Hungary
  • Mexico
  • Peru
  • Poland
  • Romania
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

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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 NCT01753193 on ClinicalTrials.gov