A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis

Genentech, Inc.31 sites in 1 country104 target enrollmentDecember 2004

ConditionsMultiple Sclerosis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Genentech, Inc.
Enrollment: 104
Locations: 31
Primary Endpoint: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with RRMS.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

December 2006

Last Updated

12 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Genentech, Inc.

Eligibility Criteria

Inclusion Criteria

•Ability and willingness to provide written informed consent and to comply with the schedule of protocol assessments
•Age 18--55 years, inclusive
•Diagnosis of relapsing MS, as defined by McDonald Criteria 1--4
•History of at least one relapse in the subject's medical records during the 1 year prior to randomization
•EDSS at screening between 0 and 5.0 points, inclusive
•For subjects of reproductive potential (males and females), ability and willingness to use a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) during the study, including the safety follow-up period, and for up to 1 year after their last dose of study drug, even if they have discontinued early from the study

Exclusion Criteria

•Pregnancy or lactation
•Incompatibility with MRI
•Lack of peripheral venous access
•History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies
•Known active bacterial, viral, fungal, or mycobacterial infection, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds or recurrent herpes infections), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 30 days prior to screening or oral antibiotics within 14 days prior to screening
•History or presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, or syphilis)
•History of cancer, including solid tumors and hematologic malignancies (except fully resolved and resected cutaneous basal cell and squamous cell carcinomas of the skin)
•History of alcohol or drug abuse within 6 months prior to screening
•History of or currently active primary or secondary immunodeficiency
•Presence of significant, uncontrolled disease of the cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal systems

Outcomes

Primary Outcomes

To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.