Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis - Full Text View

Sponsor:	Biogen Idec
Collaborator:	Elan Pharmaceuticals
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00030966

Purpose

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).

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Natalizumab Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon beta 1a Natalizumab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	1200
Study Start Date:	January 2002
Study Completion Date:	December 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.	Drug: Natalizumab Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks. Other Name: Tysabri
Placebo Comparator: Group 2 Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.	Drug: Placebo Placebo monthly infusion for up to 116 weeks. Other Name: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030966

Show 88 Study Locations

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

Investigators

Study Director:	Michael Panzara, MD, MPH	Biogen Idec
Principal Investigator:	Richard A Rudick, MD	The Cleveland Clinic

More Information

Additional Information:

The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen. This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00030966 History of Changes
Other Study ID Numbers:	C-1802
Study First Received:	February 15, 2002
Last Updated:	June 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Multiple Sclerosis
MS

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012