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Health Condition(s) or Problem
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Systemic Lupus Erythematosus; Connective Tissue Disease; Autoimmune Disease
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Lay Summary
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The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two
different doses of LY2127399 administered in addition to standard of care therapy in
patients with active SLE.
(from ClinicalTrials.gov)
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Who can enter the trial
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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:
- 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
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Who cannot enter the trial
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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:
- 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
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What will happen
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Drug; LY2127399; 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug; LY2127399 every 2 weeks; LY 2127399 every 4 weeks; Drug; Placebo every 2 weeks; Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.; Placebo; Drug; Placebo every 4 weeks; Administered via subcutaneous injection for 52 weeks.; LY 2127399 every 4 weeks
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Primary aim
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Proportion of patients achieving an SLE Responder Index response at week 52
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Secondary Aim
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Proportion of patients able to decrease dose of prednisone or equivalent with no increase in disease activity at week 52; 52 weeks; No; Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level; Baseline, 52 weeks; No; Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score; Baseline, 52 weeks; No; Time to first severe SLE flare (SFI); Baseline through 52 weeks; No; Change from baseline to 52 week endpoint in Physician's Global Assessment (PGA); Baseline, 52 weeks; No; Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQOL) composite and domain scores; Baseline, 52 weeks; No; Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks; 52 weeks; No; Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores; Baseline, 52 weeks; No; Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares; Baseline through 52 weeks; No; Proportion of patients with an increase in corticosteroids dose at 52 weeks; 52 weeks; No; 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 score; Baseline, 52 weeks; No; Change from baseline to 52 week endpoint BILAG numeric scores; Baseline, 52 weeks; No; 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 weeks; 52 weeks; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Feltham, Cambridge, Poole, London, Maidstone, Wigan
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