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Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
This study has been completed.
Sponsor:
Biogen
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen
ClinicalTrials.gov Identifier:
NCT00097760
First received: November 30, 2004
Last updated: June 17, 2009
Last verified: June 2009
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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 Intervention Model: Parallel Assignment Masking: Triple (Participant, 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
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 ]
Secondary Outcome Measures:
- Incidence and severity of adverse events. [ Time Frame: Week 20 ]
| 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) |
| Sexes Eligible for Study: | All |
| 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.
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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
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:
| 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 |
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 25, 2017