Status:
COMPLETED
Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Lupus Erythematosus, Systemic
Lupus Nephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to examine the safety of a single dose of RG2077 in patients with systemic lupus erythematosus (SLE) who are currently receiving cyclophosphamide. This study will also det...
Detailed Description
SLE is a chronic, inflammatory autoimmune disorder that may affect many organ systems, including the skin, joints, and internal organs. RG2077 has been studied for use in multiple sclerosis, another a...
Eligibility Criteria
Inclusion
- Diagnosis of SLE by American College of Rheumatology (ACR) criteria
- Concurrent treatment with intravenous cyclophosphamide (500 to 1000 mg/m2) for at least one of the following manifestations of lupus: World Health Organization (WHO) class III, IV, or V lupus nephritis; British Isles Lupus Assessment Group (BILAG) score of A for vasculitis; BILAG score of A for cytopenia; BILAG score of A for nervous system
- Stable medication regimen for at least 4 weeks prior to study entry
- Weight between 40 kg (88.2 lbs) and 125 kg (275.6 lb)
- Willing to use acceptable forms of contraception
Exclusion
- Moderately severe anemia (hemoglobin less than 8 mg/dL)
- Neutropenia (absolute neutrophil count less than 1,500/mm3)
- Thrombocytopenia (platelets less than 50,000/mm3)
- Positive tuberculin (PPD) test without evidence of prior treatment or administration of bacille Calmette-Guérin (BCG) vaccine
- Active infections, including HIV and hepatitis B or C
- Receipt of a live vaccine within 3 months of study entry
- End-stage renal disease with creatinine clearance less than 20 ml/min/1.73 m2
- History of cancer. Patients with a history of carcinoma in situ and treated basal and squamous cell carcinomas are not excluded.
- Pregnant or breastfeeding
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00094380
Start Date
September 1 2004
End Date
January 1 2006
Last Update
January 11 2017
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Columbia University Medical Center
New York, New York, United States, 10032