| November 30, 2001 |
| June 15, 2009 |
| November 2001 |
| November 2004 (final data collection date for primary outcome measure) |
| The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ] |
| The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. |
| Complete list of historical versions of study NCT00027300 on ClinicalTrials.gov Archive Site |
| Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Reduction in MRI changes and clinical relapses |
| |
| Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis |
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis |
The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Multiple Sclerosis, Relapsing-Remitting |
- Drug: Natalizumab
- Drug: Placebo
|
- Experimental: Natalizumab 300 mg, IV
- Placebo Comparator: Placebo IV infusion
|
| Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910. |
| |
| Completed |
| 900 |
| January 2005 |
| November 2004 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
- Between the ages of 18 and 50, inclusive.
- Baseline EDSS score between 0.0 and 5.0, inclusive.
- Have experienced at least one relapse within the 12 months prior to randomization.
- Cranial MRI scan demonstrating lesion(s) 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,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
- A clinically significant infectious illness within 30 days prior to randomization.
- History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent 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 performed at the Screening Visit.
|
| Both |
| 18 Years to 50 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Belgium, Canada, Czech Republic, France, Germany, Netherlands, United Kingdom |
| |
| NCT00027300 |
| Biogen Idec Medical Director, Biogen Idec |
| C-1801 |
| Biogen Idec |
| Elan Pharmaceuticals |
| Study Director: |
Michael Panzara, MD, MPH |
Biogen Idec |
|
| Principal Investigator: |
Chris Polman, MD |
VU Medical Centre |
|
|
| Biogen Idec |
| June 2009 |