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 autoimmune disorder. This study will evaluate the safety and efficacy of RG2077 in SLE patients who are currently receiving cyclophosphamide.This trial is composed of two parts. The first part is a dose-escalation study in which participants will receive one of two doses of RG2077 (0.2 mg/kg or 2 mg/kg); this part of the study will last 60 days. At screening, patients will have an IV catheter inserted into their arms for administration of cyclophosphamide and RG2077. Patients will also have medical and medication history assessments, a comprehensive physical exam, and blood and urine tests. There are 5 study visits for the first part of the trial; these will occur at screening, at study entry, and Days 1, 14, and 28. Selected visits will include physical exam, vital signs measurement, blood and urine tests, and disease activity assessment. At Days 7 and 60, patients will be contacted by phone to report their medication history and any adverse effects they have experienced.The second part of the study will evaluate a single 10 mg/kg dose of RG2077; this part of the study will last 90 days. In the study, participants will be randomly assigned to one of two groups. At the start of the study, Group 1 participants will receive RG2077 and cyclophosphamide and Group 2 participants will receive cyclophosphamide only. There will be 9 study visits; these will occur at study screening, study entry, and Days 1, 4, 7, 14, 28, and 60. At selected visits, patients will undergo physical exam, vital signs measurement, blood tests and urine tests, and disease activity assessment.

instance of dataset

2 - Complete set of descriptive data and results, as ascertained by ImmPort.

available with registration

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 determine if RG2077 is effective in decreasing disease activity in these patients.

registration required

Systemic Lupus Erythematosus

David Wofsy

Betty Diamond

University of California, San Francisco

Columbia University

principal investigator

Diamond-Wofsy ITN002AI: Treating Systemic Lupus Erythematosus (SLE) Patients with CTLA4-IgG4m (RG2077)

6

Immune Tolerance Network

Primary Outcome: Safety, as measured by the occurrence of adverse events [TimeFrame: Throughout study] [Designated as safety issue: Yes] Secondary Outcome: None

Dose-escalation: Dose-escalation portion: Low dose CTLA4-IgG4m (RG2077)

CTLA4-IgG4m: Part IIA: CTLA4-IgG4m

Control Group: Part IIA: Control Group

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 determine if RG2077 is effective in decreasing disease activity in these patients.

10.21430/M3PU4TFQBF

2004-09-01

ImmPort

SCR:012804