Natalizumab Re-Initiation of Dosing

February 14, 2017 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T2B5
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V7
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada, K7L2V7
        • Research Site
      • London, Ontario, Canada, N6A5A5
        • Research Site
      • New York, Ontario, Canada, M4N 3M5
        • Research Center
      • Ottawa, Ontario, Canada, K2G6E2
        • Research Site
      • Toronto, Ontario, Canada, M5B1W8
        • Research Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y1W7
        • Research Site
      • Greenfield Park, Quebec, Canada, J4V2H1
        • Research Site
      • Montreal, Quebec, Canada, H3A2B4
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Research Site
      • Scottsdale, Arizona, United States, 85259
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Berkeley, California, United States, 94705
        • Research Site
      • Los Angeles, California, United States, 90033
        • Research Site
      • Redwood City, California, United States, 94063
        • Research Site
      • Sacramento, California, United States, 95817
        • Research Site
      • San Francisco, California, United States, 94117
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80919
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Maitland, Florida, United States, 32751
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
      • Pompano Beach, Florida, United States, 33060
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Research Site
    • Illinois
      • Arlington, Illinois, United States, 60007
        • Research Site
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States, 60637
        • Research Site
      • Northbrook, Illinois, United States, 60062
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Research Site
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Research Site
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Research Site
    • New York
      • Albany, New York, United States, 12208
        • Research Site
      • Buffalo, New York, United States, 14203
        • Research Site
      • Great Neck, New York, United States, 10019
        • Research Site
      • New York, New York, United States, 10003
        • Research Site
      • New York, New York, United States, 10319
        • Research Site
      • Staten Island, New York, United States, 10305
        • Research Site
      • Syracuse, New York, United States, 13202
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19146
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Research Site
      • Nashville, Tennessee, United States, 37215
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75214
        • Research Site
      • Round Rock, Texas, United States, 78681
        • Research Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Natalizumab
All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
Biological: BG00002 (natalizumab)
Other Names:
  • Tysabri

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: Baseline through Week 48
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
Number of Participants With Hypersensitivity-related Adverse Events
Time Frame: Baseline through Week 48
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
Number of Participants With Antibodies to Natalizumab
Time Frame: Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)
'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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

March 22, 2006

First Posted (Estimate)

March 24, 2006

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-MS-322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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