Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Tracking Information
First Submitted Date ICMJE	November 30, 2001
First Posted Date ICMJE	December 3, 2001
Last Update Posted Date	January 9, 2017
Study Start Date ICMJE	November 2001
Actual Primary Completion Date	November 2004 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 15, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00027300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 15, 2009)	Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Multiple Sclerosis, Relapsing-Remitting
Intervention ICMJE	Drug: Natalizumab Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks. Other Name: Tysabri; Drug: Placebo Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
Study Arms	Experimental: Group 1 Natalizumab 300 mg, IV Intervention: Drug: Natalizumab; Placebo Comparator: Group 2 Placebo IV infusion Intervention: Drug: Placebo
Publications *	Voloshyna N, Havrdová E, Hutchinson M, Nehrych T, You X, Belachew S, Hotermans C, Paes D. Natalizumab improves ambulation in relapsing-remitting multiple sclerosis: results from the prospective TIMER study and a retrospective analysis of AFFIRM. Eur J Neurol. 2015 Mar;22(3):570-7. doi: 10.1111/ene.12618. Epub 2014 Dec 15.; 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.; Balcer LJ, Galetta SL, Polman CH, Eggenberger E, Calabresi PA, Zhang A, Scanlon JV, Hyde R. Low-contrast acuity measures visual improvement in phase 3 trial of natalizumab in relapsing MS. J Neurol Sci. 2012 Jul 15;318(1-2):119-24. doi: 10.1016/j.jns.2012.03.009. Epub 2012 Apr 21.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 12, 2006)	900
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	January 2005
Actual Primary Completion Date	November 2004 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Canada, Czech Republic, France, Germany, Netherlands, United Kingdom, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00027300
Other Study ID Numbers ICMJE	C-1801
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Biogen Idec Medical Director, Biogen Idec
Study Sponsor ICMJE	Biogen
Collaborators ICMJE	Elan Pharmaceuticals
Investigators ICMJE	Study Director: Michael Panzara, MD, MPH Biogen Principal Investigator: Chris Polman, MD VU Medical Centre
PRS Account	Biogen
Verification Date	January 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP