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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097760
• Other study ID #: C-1803
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2004
• Last updated: June 17, 2009
• Start date: June 2003
• Est. completion date: March 2004

Study information

• Verified date: June 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Natalizumab
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
• Natalizumab
Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
• Placebo
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of development of new active lesions on MRI scans.		Week 20	No
Secondary	Incidence and severity of adverse events.		Week 20	Yes

External Links

•   MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen.
•   The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.