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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00094380
Date of registration: 16/10/2004
Prospective Registration: Yes
Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Public title: Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)
Scientific title: Treatment of Systemic Lupus Erythematosus With CTLA4-IgG4m Plus Cyclophosphamide: A Phase I/IIA Study
Date of first enrolment: September 2004
Target sample size: 6
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00094380
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Name:     Betty Diamond, MD
Address: 
Telephone:
Email:
Affiliation:  Columbia University
Name:     David Wofsy, MD
Address: 
Telephone:
Email:
Affiliation:  University of California, San Francisco
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Lupus Erythematosus, Systemic
Lupus Nephritis
Intervention(s)
Drug: CTLA4-IgG4m (RG2077)
Drug: Cyclophosphamide
Primary Outcome(s)
Safety, as measured by the occurrence of adverse events [Time Frame: Throughout study]
Secondary Outcome(s)
Lupus serology [Time Frame: Throughout study]
Renal function [Time Frame: Throughout study]
SLE disease activity [Time Frame: Throughout study]
Secondary ID(s)
DAIT ITN002AI
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Immune Tolerance Network (ITN)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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