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

Study Overview
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Brief Summary
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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 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.

Official Title
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An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g

Conditions
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Lupus Erythematosus, Systemic

Intervention / Treatment
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* Drug: Rituximab
* Drug: Methylprednisolone
* Drug: Acetaminophen
* Drug: Diphenhydramine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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 Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab 1000 mg<br>Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion. | Drug: Rituximab<br>* Rituximab will be supplied as a liquid for intravenous infusion.<br>Drug: Methylprednisolone<br> <br> Drug: Acetaminophen<br> <br> Drug: Diphenhydramine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 1 Serious Adverse Event | A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator. | Baseline to the end of the study (up to 52 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rituxan, SLE, Lupus