Status:
COMPLETED
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Lead Sponsor:
Genentech, Inc.
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
PHASE3
Brief 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 backgr...
Eligibility Criteria
Inclusion
- 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
- 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.
- History of deep space infection.
- History of serious recurrent or chronic infection.
- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
- Active alcohol or drug abuse, or history of alcohol or drug abuse.
- Major surgery.
- Previous treatment with CAMPATH-1H antibody.
- Previous treatment with any B cell-targeted therapy.
- Treatment with any investigational agent within 28 days of screening (Day -7) or 5 half-lives of the investigational drug (whichever is longer).
- Receipt of a live vaccine within 28 days prior to screening.
- Intolerance or contraindication to oral or IV corticosteroids.
- Use of a new immunosuppressive drug prior to screening or change in dose of ongoing immunosuppressive drug prior to screening.
- Prednisone dose of ≥ 1 mg/kg/day prior to screening.
- Treatment with cyclophosphamide or a calcineurin inhibitor.
- Treatment with a second immunosuppressive or immunomodulatory drug.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x the upper limit of normal.
Key Trial Info
Start Date :
May 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2008
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00137969
Start Date
May 10 2005
End Date
August 25 2008
Last Update
August 20 2019
Active Locations (65)
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1
Univ of Alabama School of Med; Clinical Immun Rheumatology
Birmingham, Alabama, United States, 35294
2
Rheumatology Assoc of North AL
Huntsville, Alabama, United States, 35801
3
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, United States, 85253
4
Univ of California, San Diego
La Jolla, California, United States, 92037