Status:
TERMINATED
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:
PHASE3
Brief Summary
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 ...
Eligibility Criteria
Inclusion
- Subjects with systemic lupus erythematosus (SLE) who participated and satisfactorily completed their Week 52 evaluation in Study U2971g.
- For partial clinical response (PCR) or nonclinical response (NCR), active disease at screening as defined by one or more domains with a British Isles Lupus Assessment Group (BILAG) A score or 2 or more domains with a BILAG B score.
Exclusion
- Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.
- Any safety concern potentially attributed to rituximab that in the investigator's opinion would jeopardize subject safety.
- Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.
- Subjects, that in the investigator's opinion, have not demonstrated any clinical improvement by Week 52 in study U2971g and in whom the proposed therapy would represent risk without benefit.
- Unstable subjects 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.
- Pregnant women or nursing (breastfeeding) mothers.
- History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
- 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 within 8 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
- Major surgery within 4 weeks prior to screening.
- Intolerance or contraindication to oral or IV corticosteroids.
- Positive hepatitis B surface antigen (BsAg) or hepatitis C serology.
- Receipt of a live vaccine within 28 days prior to treatment.
Key Trial Info
Start Date :
June 22 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00381810
Start Date
June 22 2006
End Date
February 29 2012
Last Update
August 1 2017
Active Locations (11)
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1
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, United States, 85253
2
Eden Medical Center San Leandro Hospital
San Leandro, California, United States, 94578
3
Intermountain Research Center
Boise, Idaho, United States, 83702
4
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, United States, 83814