Conditions: Lupus Erythematosus, Systemic
Keywords: Rituxan SLE Lupus
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 31
Healthy volunteers: no

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:

Arms:
arm 1: 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.

Interventions: intervention 1: Rituximab intervention 2: Methylprednisolone intervention 3: Acetaminophen intervention 4: Diphenhydramine
Intervention descriptions: intervention 1: Rituximab will be supplied as a liquid for intravenous infusion. intervention 2: None intervention 3: None intervention 4: None

Protocol document: