A clinical trial to check the efficacy and safety of MEDI-546 (Study drug) in subjects with Systemic Lupus Erythematosus
- Conditions
- Health Condition 1: null- Systemic Lupus Erythematosus
- Registration Number
- CTRI/2012/12/003190
- Lead Sponsor
- MedImmune LLC a member of the AstraZeneca Group of
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving a response in an <br/ ><br>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 <br/ ><br>until Day 169 will be declared non-responders for the primary endpoint at Day 169.Timepoint: Day 169 (week 24)
- Secondary Outcome Measures
Name Time Method 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)