A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants with Systemic Lupus Erythematosus or Myositis

Study identifier:MI-CP212

ClinicalTrials.gov identifier:NCT00979654

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects with Systemic Lupus Erythematosus or Myositis

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 2

Healthy volunteers

No

Study drug

Sifalimumab

Sex

All

Actual Enrollment

118

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Aug 2010
Primary Completion Date: 01 Mar 2015
Study Completion Date: 01 Mar 2015

Study design

Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2016 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

PPD

Inclusion and exclusion criteria