EUCTR2011-004296-36-BG
Active, not recruiting
Phase 1
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus
MedImmune, LLC,0 sites300 target enrollmentMarch 14, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MedImmune, LLC,
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti\-double\-stranded DNA or anti\-Smith antibody at screening
- •Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
- •Weight greater than or equal to 40 kg
- •Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
- •Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
- •No evidence of cervical malignancy on Pap smear within 2 years of randomization
- •Female subjects must be willing to avoid pregnancy
- •Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Active severe SLE\-driven renal disease or unstable renal disease prior to screening
- •Active severe or unstable neuropsychiatric SLE
- •Clinically significant active infection including ongoing and chronic infections
- •History of human immunodeficiency virus (HIV)
- •Confirmed Positive tests for hepatitis B or positive test for hepatitis C
- •History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
- •Live or attenuated vaccine within 4 weeks prior to screening
- •Subjects with significant hematologic abnormalities
Outcomes
Primary Outcomes
Not specified
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