| February 15, 2002 |
| June 17, 2009 |
| January 2002 |
| April 2005 (final data collection date for primary outcome measure) |
| Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ] |
| The primary outcome objective was to determine whether add natalizumab to Avonex reduces the number clinical relapses and the level of disability at 1 year |
| Complete list of historical versions of study NCT00030966 on ClinicalTrials.gov Archive Site |
| If this combination reduces MRI lesions and the overall rate of clinical relapses [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ] |
| If this combination reduces MRI lesions and the overall rate of clinical relapses |
| |
| Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis |
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis |
The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS). |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Multiple Sclerosis, Relapsing-Remitting |
- Drug: Natalizumab
- Drug: Placebo
|
- Experimental: Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
- Placebo Comparator: Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
|
| Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23. |
| |
| Completed |
| 1200 |
| December 2005 |
| April 2005 (final data collection date for primary outcome measure) |
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 Avonex for at least the 12 months prior to randomization
- Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
- Cranial MRI scan demonstrating lesions consistent with MS.
- Have given written informed consent to participate in the study.
Exclusion Criteria:
- Primary progressive, secondary progressive, or progressive relapsing MS.
- MS relapse has occurred within 50 days of randomization
- A clinically significant infectious illness within 30 days prior to randomization
- History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks.
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3
- Abnormal blood tests at Screening Visit
|
| Both |
| 18 Years to 55 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Austria, Belgium, France, Germany, Israel, Italy |
| |
| NCT00030966 |
| Biogen Idec MD, Biogen Idec |
| C-1802 |
| Biogen Idec |
| Elan Pharmaceuticals |
| Study Director: |
Michael Panzara, MD, MPH |
Biogen Idec |
|
| Principal Investigator: |
Richard A Rudick, MD |
The Cleveland Clinic |
|
|
| Biogen Idec |
| June 2009 |
