Status:
COMPLETED
PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
Lead Sponsor:
Anthera Pharmaceuticals
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
Eligibility Criteria
Inclusion
- Diagnosis of SLE by American College of Rheumatology guidelines.
- On stable SLE treatment
- Active SLE disease
- Serologically active
- 18 years of age or older
- Receiving stable doses of prednisone between 7.5 mg and 40 mg per day
Exclusion
- Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
- Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
- Liver disease.
- Anemia, neutropenia, or thrombocytopenia.
- Malignancy within past 5 years
- Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
- History of active tuberculosis or a history of tuberculosis infection.
- Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
- Prior administration of any B cell depleting therapy in the past 18 months.
- Pregnant or nursing
- History of congenital immunodeficiency
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
547 Patients enrolled
Trial Details
Trial ID
NCT01162681
Start Date
July 1 2010
End Date
April 1 2012
Last Update
March 4 2014
Active Locations (74)
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1
Investigator Site 103
Birmingham, Alabama, United States, 35294
2
Investigator Site 113
Long Beach, California, United States, 90806
3
Investigator Site 108
Los Angeles, California, United States, 90095
4
Investigator Site 110
Upland, California, United States, 91786