A Study of LY2127399 in Patients With Systemic Lupus Erythematosus
- Conditions
- Health Condition 1: null- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
- Registration Number
- CTRI/2011/10/002093
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 1140
Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria
-Have positive antinuclear antibodies (ANA)
-Agree not to become pregnant throughout the course of the trial
-Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score at screening
-Have active severe Lupus kidney disease
-Have active Central Nervous System or peripheral neurologic disease
-Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
-Have active or recent infection within 30 days of screening
-Have had a serious infection within 90 days of randomization
-Have evidence or test positive for Hepatitis B
-Have Hepatitis C
-Are human immunodeficiency virus (HIV) positive
-Have evidence of active or latent tuberculosis (TB)
-Presence of significant laboratory abnormalities at screening
-Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
-Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
-Have changed your dose of antimalarial drug in the past 30 days
-Have changed your dose of immunosuppressive drug in the past 90 days
-Have previously received rituximab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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