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

Purpose

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).

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Natalizumab Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Glatiramer Glatiramer acetate Natalizumab

U.S. FDA Resources

Further study details as provided by Biogen:

Primary Outcome Measures:

Rate of development of new active lesions on MRI scans. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence and severity of adverse events. [ Time Frame: Week 20 ] [ Designated as safety issue: Yes ]


Enrollment:	110
Study Start Date:	June 2003
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.	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. Other Name: Tysabri Drug: Natalizumab Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks. Other Name: Tysabri
Placebo Comparator: Group 2 Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.	Drug: Placebo Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097760

Sponsors and Collaborators

Biogen

Elan Pharmaceuticals

Investigators


Study Director:	Biogen Idec, MD	Biogen

More Information

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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


Responsible Party:	Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier:	NCT00097760 History of Changes
Other Study ID Numbers:	C-1803
Study First Received:	November 30, 2004
Last Updated:	June 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen:


Multiple Sclerosis MS

Additional relevant MeSH terms:


Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases	Immune System Diseases Natalizumab Glatiramer Acetate Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Immunosuppressive Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on September 29, 2016