Natalizumab Re-Initiation of Dosing

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306592
• Other study ID #: 101-MS-322
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2006
• Last updated: March 11, 2015
• Start date: March 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.

Description:

Study 101-MS-322 (NCT00306592) is conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab of former clinical trial participants in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760). This study includes participants in North America. In parallel with the conduct of this study, a similar study, 101-MS-321 (NCT00297232) is initiated for participants in Europe and the rest of the world. The primary purpose and primary outcome for both studies are identical, therefore, the combined Week 48 data from both studies are presented. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) can enter study 101-MS-321 (NCT 00297232), which is considered the Long-Term Treatment Period of 101-MS-322 (NCT00306592).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging [MRI] scan)

• Considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 [NCT000276172] may be used)

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Considered by the investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment

• History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies

• Other protocol-defined exclusion criteria may apply

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Biological:
• BG00002 (natalizumab)

Locations

Country	Name	City	State
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Center	New York	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
United States	Research Site	Albany	New York
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Arlington	Illinois
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Berkeley	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Buffalo	New York
United States	Research Site	Burlington	Vermont
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Dallas	Texas
United States	Research Site	Des Moines	Iowa
United States	Research Site	East Lansing	Michigan
United States	Research Site	Fargo	North Dakota
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Great Neck	New York
United States	Research Site	Kansas City	Kansas
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	Maitland	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Northbrook	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pompano Beach	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Redwood City	California
United States	Research Site	Round Rock	Texas
United States	Research Site	Sacramento	California
United States	Research Site	San Francisco	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Staten Island	New York
United States	Research Site	Syracuse	New York
United States	Research Site	Teaneck	New Jersey
United States	Research Site	Washington	District of Columbia
United States	Research Site	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)	AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.	Baseline through Week 48	Yes
Primary	Number of Participants With Hypersensitivity-related Adverse Events	For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.	Baseline through Week 48	Yes
Primary	Number of Participants With Antibodies to Natalizumab	'Positive with unknown persistence' is defined as a positive result (=0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.	Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)	Yes

External Links

•   (MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen Idec.)
•   The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.)