Anti-CD20 in Systemic Lupus Erythematosus

Phase 1

Completed

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Drug: Rituximab

• Registration Number: NCT00036491
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

The purpose of this study is to determine the safety and effectiveness of rituximab (anti-CD20) in treating systemic lupus erythematosus (SLE).

White blood cells in the body called B cells give off substances that are active in promoting SLE disease. Researchers have found that anti-CD20 can block production of these substances in another disease. This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE.

Detailed Description

B cells clearly play an essential role in the pathogenesis of SLE since they produce autoantibodies. Clinical observations support the contention that intervening in the production of autoantibodies by the B lymphocyte will be effective therapy. Current approved therapy for B-cell non-Hodgkin's lymphoma includes anti-CD20. The results of anti-CD20 administration in SLE are anticipated to be similar to those in lymphoma patients. The current proposal explores the mechanisms and applicability of B-cell depletion as a potential treatment for SLE.

Participants receive 4 weekly infusions of study medication. Each participant is enrolled in the study for a total of 1 year with protocol visits weekly for the first 3 months, then every other week for the next 2 months, every month for the next 4 months, and every other month for the remaining 5 months of the study (Weeks 0, 1, 2, 3, 4, 5, 6, 7, 9, 11, 13, 15, 19, 23, 27, 31, 39, 47, and 55). Responses to exogenous antigens are measured; assessments for clinical response with SLE-disease activity score (SLEDEI) and systemic lupus activity measure (SLAM) score are performed. Participants complete a health questionnaire and a health survey and laboratory parameters are evaluated.

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2002-05-10
• Study First Submitted QC: 2002-05-10
• Study First Posted: 2002-05-13
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rituximab	Rituximab	375 mg/m\^2 administered intravenously

Primary Outcome Measures

Name	Time	Method
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)	Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55
Serum Autoantibodies	Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56

Secondary Outcome Measures

Name	Time	Method
Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index for SLE
Modified Health Assessment Questionnaire (HAQ)
Short Form-36 Health Survey (SF-36)
C3 and C4 complement levels
Prednisone Dose	Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56
Patient Global Assessment (VAS)
Renal Function		Measured by creatinine clearance and total protein.
Systemic Lupus Activity Measure (SLAM)	Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55
Erythrocyte Sedimentation Rate (ESR)
Physician Global Assessment (VAS)
Adverse Events

Trial Locations

Locations (3)

University of Rochester; 🇺🇸 Rochester, New York, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States