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

Genentech

Status and phase: Terminated; Phase 3

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Methylprednisolone; Drug: Rituximab; Drug: Acetaminophen; Drug: Diphenhydramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00381810

U3389g

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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• Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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• Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Rituximab 1000 mg

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: Rituximab

Drug: Methylprednisolone

Drug: Diphenhydramine