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

Phase 3

Terminated

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Drug: Rituximab; Drug: Methylprednisolone; Drug: Acetaminophen; Drug: Diphenhydramine

• Registration Number: NCT00381810
• Lead Sponsor: Genentech, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-22
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-28
• Primary Completion: 2008-07-31
• Results First Submitted: 2009-11-11
• Results First Submitted QC: 2009-11-12
• Results First Posted: 2009-12-18
• Study Completion: 2012-02-29
• Status Verified: 2017-06
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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• Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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• Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab 1000 mg	Rituximab	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.
Rituximab 1000 mg	Methylprednisolone	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.
Rituximab 1000 mg	Diphenhydramine	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.
Rituximab 1000 mg	Acetaminophen	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least 1 Serious Adverse Event	Baseline to the end of the study (up to 52 weeks)	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.

Trial Locations

Locations (11)

Arizona Arthritis & Rheumatology Research, Pllc; 🇺🇸 Paradise Valley, Arizona, United States

Eden Medical Center San Leandro Hospital; 🇺🇸 San Leandro, California, United States

Intermountain Research Center; 🇺🇸 Boise, Idaho, United States

Coeur D'Alene Arthritis Clinic; 🇺🇸 Coeur d'Alene, Idaho, United States

Oklahoma Medical Research Foundation; 🇺🇸 Oklahoma City, Oklahoma, United States

Seattle Rheumatology Assoc; Swedish Rheumatology Research; 🇺🇸 Seattle, Washington, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology; 🇺🇸 Great Neck, New York, United States

Texas Research Center; 🇺🇸 Sugar Land, Texas, United States

Medical Univ of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States