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

Part of paid clinical trials in Paradise Valley, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT00381810
Phase
PHASE3
Status
Terminated

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab will be supplied as a liquid for intravenous infusion.
  • Methylprednisolone — DRUG
  • Acetaminophen — DRUG
  • Diphenhydramine — DRUG

Study Details

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.

Key Dates

Start date
Jun 22, 2006
Status verified
Jun 2017
Primary completion
Jul 31, 2008
Completion
Feb 29, 2012

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab 1000 mg
    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 Measure

Percentage of Participants With at Least 1 Serious Adverse Event [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]

Locations (11)

FacilityCityStateZIPSite coordinators
Arizona Arthritis & Rheumatology Research, PllcParadise ValleyArizona85253-
Eden Medical Center San Leandro HospitalSan LeandroCalifornia94578-
Intermountain Research CenterBoiseIdaho83702-
Coeur D'Alene Arthritis ClinicCoeur d'AleneIdaho83814-
University of ChicagoChicagoIllinois60637-
University of Kansas Medical CenterKansas CityKansas66160-
North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical ImmunologyGreat NeckNew York11021-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-
Medical Univ of South CarolinaCharlestonSouth Carolina29425-
Texas Research CenterSugar LandTexas77479-
Seattle Rheumatology Assoc; Swedish Rheumatology ResearchSeattleWashington98104-

Find similar trials in Paradise Valley, AZ

By research site
Arizona Arthritis & Rheumatology Research, Pllc· Paradise Valley, AZEden Medical Center San Leandro Hospital· San Leandro, CAIntermountain Research Center· Boise, IDCoeur D'Alene Arthritis Clinic· Coeur d'Alene, IDUniversity of Chicago· Chicago, ILUniversity of Kansas Medical Center· Kansas City, KS

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