A Phase 2 interventional study of Natalizumab and Natalizumab in Multiple Sclerosis, Relapsing-Remitting, sponsored by Biogen. Completed. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2009-06-18.
Sponsored by Biogen · Phase 2, Interventional, and Treatment
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 110 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Also known as: Tysabri
Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
Also known as: Tysabri
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Rate of development of new active lesions on MRI scans.
Time frame: Week 20
Incidence and severity of adverse events.
Time frame: Week 20
No study locations are listed for this record.
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Biogen