Health Condition 1: null- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
Conditions
Interventions
Intervention1: LY2127399 - every 4 weeks: 120mg administered via subcutaneous injection every four weeks for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. During
240 mg loading dose will be administered as the first dose of study drug
Control Intervention1: placebo: Administered via subcutaneous injection every two weeks for 52 weeks. A matching loading dose w
Sponsors
Eli Lilly
Parexel
Eligibility
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving an SLE Responder Index response at week 52Timepoint: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeksTimepoint: 52 weeks;Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flaresTimepoint: baseline through 52 weeks;Time to first severe SLE flare (SFI)Timepoint: baseline through 52 weeks;Change from baseline to 52 week endpoint BILAG numeric scoresTimepoint: baseline, 52 weeks;Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scoresTimepoint: baseline, 52 weeks;Change from baseline to 52 week endpoint in Physicians Global Assessment (PGA)Timepoint: baseline, 52 weeks;Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) scoreTimepoint: baseline, 52 weeks;Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQOL) composite and domain scoresTimepoint: baseline, 52 weeks;Change from baseline to 52 weeks endpoint in Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) disease activity scoreTimepoint: baseline, 52 weeks;Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) levelTimepoint: baseline, 52 weeks;Proportion of patients able to decrease dose of prednisone or equivalent with no increase in disease activity at week 52Timepoint: 52 weeks;Proportion of patients achieving a response as measured by modified SLE Responder Index (SRI) with no BILAG A or no more than 1 BILAG B organ domain flares at 52 weeksTimepoint: 52 weeks;Proportion of patients with an increase in corticosteroids dose at 52 weeksTimepoint: 52 weeks | — |
Countries
Australia, Brazil, Canada, Ecuador, France, Hungary, India, Israel, Latvia, Malaysia, Mexico, New Zealand, Romania, Russian Federation, Serbia, South Africa, Spain, Taiwan, Tunisia, United Kingdom, United States of America
Contacts
Public ContactAnil Seth
Eli Lilly
Outcome results
None listed