Status:
COMPLETED
Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of ataci...
Eligibility Criteria
Inclusion
- Male or female 16 years of age or older
- Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE
- Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids
- Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening
- Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication
- Other protocol defined inclusion criteria could apply
Exclusion
- Active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol
- Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol
- Previous treatment with rituximab, abatacept, or belimumab
- History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis
- Other protocol defined exclusion criteria could apply
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT00624338
Start Date
January 1 2008
End Date
October 1 2012
Last Update
March 14 2016
Active Locations (113)
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1
Division of Clinical Immunology and Rheumatology - UAB
Birmingham, Alabama, United States, 35249-7201
2
Stanford University
Palo Alto, California, United States
3
Research Site
San Diego, California, United States
4
Inland Rheumatology Clinical Trials Inc
Upland, California, United States