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Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Natalizumab (Drug); Natalizumab (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Biogen Idec, MD, Study Director, Affiliation: Biogen


The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).

Clinical Details

Official title: Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rate of development of new active lesions on MRI scans.

Secondary outcome: Incidence and severity of adverse events.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of MS as defined by McDonald et al., criteria # 1-4

- Between the ages of 18 and 55, inclusive

- Baseline EDSS score between 0. 0 and 5. 0, inclusive

- Have been treated with GA for at least the 12 months prior to randomization

Exclusion Criteria:

- Primary progressive, secondary progressive or progressive relapsing MS

- MS relapse has occurred within the 50 days prior to randomization

- A clinically significant infectious illness

- History of, or abnormal lab result indicative of significant disease that would

preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.

Locations and Contacts

Additional Information

The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.

MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen.

Starting date: June 2003
Last updated: June 17, 2009

Page last updated: August 23, 2015

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