Health Condition 1: null- Systemic Lupus Erythematosus
Conditions
Interventions
Intervention1: MEDI-546-100mg/ml solution: MEDI-546(300 or 1000 mg)will be administered as an IV infusion via an infusion pump,over approximately 60 ± 5 minutes q4wks for a total of 13 doses (Days 1,
Sponsors
MedImmune LLC a member of the AstraZeneca Group of
Kendle India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematotus (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 2.Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks 3. Weight greater than or equal to 40 kg 4. • Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives 5.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 6. No evidence of cervical malignancy on Pap smear within 2 years of randomization 7.Female subjects must be willing to avoid pregnancy 8. Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization
Exclusion criteria
Exclusion criteria: 1.Active severe SLE-driven renal disease or unstable renal disease prior to screening 2. Active severe or unstable neuropsychiatric SLE 3. Clinically significant active infection including ongoing and chronic infections 4. History of human immunodeficiency virus (HIV) 5. Confirmed Positive tests for hepatitis B or positive test for hepatitis C 6. History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes 7. Live or attenuated vaccine within 4 weeks prior to screening 8. Subjects with significant hematologic abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a response in an SLE responder index [SRI(4)] at Day 169 in subjects with chronic, moderately-to-severely active SLE. Subjects who are unable to taper OCS to 10 mg/day and â?¤ Day 1 dose of prednisone or equivalent by Day 85 and maintain OCS doses 10 mg/day and â?¤ Day 1 dose until Day 169 will be declared non-responders for the primary endpoint at Day 169.Timepoint: Day 169 (week 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieve a response in an SRI(4) at Day 365 will be compared between treatment groups using logistic regression model. Subjects who are unable to reduce OCS to 10 mg/day and â?¤ Day 1 dose of prednisone or equivalent by Day 281 will be declared as non-respondersTimepoint: Day 365 (Week 52) | — |
Countries
Colombia, India, Mexico, United States of America
Contacts
Public ContactMamta Singh
Kendle India Private Limited
Outcome results
None listed