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

PHASE2CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Sifalimumab

All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.

Trial Locations (28)

Unknown

Research Site, Anniston

Research Site, Scottsdale

Research Site, San Leandro

Research Site, Upland

Research Site, Colorado Springs

Research Site, Fort Lauderdale

Research Site, Ocala

Research Site, Tampa

Research Site, Baltimore

Research Site, Cumberland

Research Site, Boston

Research Site, Ann Arbor

Research Site, Lansing

Research Site, Lake Success

Research Site, Manhasset

Research Site, New York

Research Site, Charlotte

Research Site, Cincinnati

Research Site, Oklahoma City

Research Site, Portland

Research Site, Duncansville

Research Site, Columbia

Research Site, Dallas

Research Site, Houston

Research Site, Curitiba

Research Site, São Paulo

Research Site, Winnipeg

Research Site, Santiago

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

MedImmune LLC

INDUSTRY

NCT00979654 - A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis | Biotech Hunter | Biotech Hunter