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A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus

NCT00137969•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.

Eligibility

Age

16 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of systemic lupus erythematosus (SLE).
•Active disease at screening.
•Stable use of one immunosuppressive drug.
•Use of an antimalarial drug.
•For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation.

Exclusion Criteria

•Unstable patients with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
•Active moderate to severe glomerulonephritis.
•Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
•Lack of peripheral venous access.
•Pregnant women or nursing (breast feeding) mothers.
•History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
•Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude subject participation.
•Concomitant conditions that require oral or systemic corticosteroid use.
•Known human immunodeficiency virus (HIV) infection.
•Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics.
+15 more criteria

Locations (65)

Univ of Alabama School of Med; Clinical Immun Rheumatology

Birmingham, Alabama, United States

Rheumatology Assoc of North AL

Huntsville, Alabama, United States

Arizona Arthritis & Rheumatology Research, Pllc

Paradise Valley, Arizona, United States

Univ of California, San Diego

La Jolla, California, United States

Univ of Calif., Los Angeles; Rheumatology

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Stanford University Med Ctr;Div of Immunology/Rheumatology

Palo Alto, California, United States

Univ of Calif, San Francisco; Rheumatology

San Francisco, California, United States

Eden Medical Center San Leandro Hospital

San Leandro, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Key Dates

Start Date

May 10, 2005

Primary Completion Date

August 25, 2008

Completion Date

August 25, 2008

Last Updated

August 20, 2019

Enrollment

262

ACTUAL participants

Conditions

Lupus Erythematosus, Systemic

Interventions

Rituximab

DRUG

Placebo

DRUG

Prednisone

DRUG

Acetaminophen

DRUG

Diphenhydramine

DRUG

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

View study

RECRUITINGPHASE3

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

NCT07438496

Lupus Erythematosus, Systemic

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases