Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT00097760 |
Recruitment Status
:
Completed
First Posted
: December 1, 2004
Last Update Posted
: June 18, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
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) |
Study Start Date : | June 2003 |
Actual Primary Completion Date : | March 2004 |
Actual Study Completion Date : | March 2004 |

Arm | Intervention/treatment |
---|---|
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.
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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.
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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.
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- Rate of development of new active lesions on MRI scans. [ Time Frame: Week 20 ]
- Incidence and severity of adverse events. [ Time Frame: Week 20 ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097760
Study Director: | Biogen Idec, MD | Biogen |
Additional Information:
Responsible Party: | Biogen Idec MD, Biogen Idec, Inc. |
ClinicalTrials.gov Identifier: | NCT00097760 History of Changes |
Other Study ID Numbers: |
C-1803 |
First Posted: | December 1, 2004 Key Record Dates |
Last Update Posted: | June 18, 2009 |
Last Verified: | June 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 |