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Natalizumab (Tysabri) Re-Initiation of Dosing (STRATA)

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Natalizumab
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, MS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the IMA 04001 (STARS) Study Subjects who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and glatiramer acetate) while being treated with natalizumab during the study. In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480). Key Exclusion Criteria Considered by the Investigator to be immunocompromised History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies History of any major disease or malignancy Discontinued natalizumab in a previous study due to allergic reaction NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Natalizumab

Arm Description

300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks

Outcomes

Primary Outcome Measures

Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression
Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.
Time to 48-week Confirmed EDSS Progression
Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.
Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0
Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as ≥ 1.0 point decrease from baseline sustained for 24 weeks.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2006
Last Updated
June 16, 2016
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00297232
Brief Title
Natalizumab (Tysabri) Re-Initiation of Dosing
Acronym
STRATA
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, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.
Detailed Description
Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab in former clinical trial participants in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760) and included subjects in North America. In parallel with the conduct of that study, this study (101-MS-321 [NCT00297232]) was initiated for participants in Europe and the rest of the world. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) could enter study 101-MS-321 (NCT 00297232), which was considered the Long-Term Treatment Period of 101-MS-322 (NCT00306592). The primary purpose and primary outcome for both studies are identical; therefore, the combined long-term data from both studies are presented. (Combined Week 48 data from both studies are presented in the 101-MS-322 [NCT00306592] record.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, MS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1094 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natalizumab
Arm Type
Experimental
Arm Description
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
Intervention Type
Drug
Intervention Name(s)
Natalizumab
Other Intervention Name(s)
Tysabri (BG00002)
Primary Outcome Measure Information:
Title
Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression
Description
Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.
Time Frame
up to 480 weeks
Title
Time to 48-week Confirmed EDSS Progression
Description
Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.
Time Frame
up to 480 weeks
Title
Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0
Description
Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as ≥ 1.0 point decrease from baseline sustained for 24 weeks.
Time Frame
Up to 480 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the IMA 04001 (STARS) Study Subjects who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and glatiramer acetate) while being treated with natalizumab during the study. In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480). Key Exclusion Criteria Considered by the Investigator to be immunocompromised History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies History of any major disease or malignancy Discontinued natalizumab in a previous study due to allergic reaction NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Research Site
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Research Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Research Site
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium
Facility Name
Research Site
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Facility Name
Research Site
City
Sijsele
ZIP/Postal Code
8340
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Belgium
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
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Canada
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Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H IV7
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Canada
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Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
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Canada
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City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
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Canada
Facility Name
Research Site
City
New York
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
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Canada
Facility Name
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City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G6E2
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Canada
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City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
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Canada
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City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W7
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Canada
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City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
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Canada
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Montreal
State/Province
Quebec
ZIP/Postal Code
H3A2B4
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Canada
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Brno
ZIP/Postal Code
625 00
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Czech Republic
Facility Name
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Brno
ZIP/Postal Code
656 91
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Czech Republic
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Research Site
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Hradec Kralove
ZIP/Postal Code
500 05
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Czech Republic
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Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
ZIP/Postal Code
532 03
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Czech Republic
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
323 00
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Czech Republic
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
12000
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Czech Republic
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Research Site
City
Praha 5
ZIP/Postal Code
150 06
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Czech Republic
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Research Site
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Aarhus C
ZIP/Postal Code
8000
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Denmark
Facility Name
Research Site
City
Esbjerg
ZIP/Postal Code
6700
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Denmark
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Research Site
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Kobenhavn
ZIP/Postal Code
2100
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Denmark
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Helsinki
ZIP/Postal Code
00290
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Finland
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Research Site
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Tampere
ZIP/Postal Code
33520
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Finland
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Research Site
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Turku
ZIP/Postal Code
20100
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Finland
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Besancon
ZIP/Postal Code
25030
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France
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Bordeaux
ZIP/Postal Code
33076
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France
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Clermont-Ferrand
ZIP/Postal Code
63003
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France
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Creteil
ZIP/Postal Code
94101
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France
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Dijon
ZIP/Postal Code
21033
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France
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Research Site
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Lille
ZIP/Postal Code
59037
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France
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Research Site
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Lyon
ZIP/Postal Code
69677
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France
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Research Site
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Marseille
ZIP/Postal Code
13385
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France
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Research Site
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31059
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France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13347
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Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45122
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Germany
Facility Name
Research Site
City
Gießen
ZIP/Postal Code
35385
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Germany
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Research Site
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Hannover
ZIP/Postal Code
30625
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Germany
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Hennigsdorf
ZIP/Postal Code
16761
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Germany
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München
ZIP/Postal Code
81377
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Germany
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Offenbach
ZIP/Postal Code
63069
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Germany
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Osnabrück
ZIP/Postal Code
49076
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Germany
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Regensburg
ZIP/Postal Code
93053
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Germany
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Rostock
ZIP/Postal Code
18147
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Germany
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Athens
ZIP/Postal Code
11527
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Greece
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Budapest
ZIP/Postal Code
1021
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Hungary
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City
Budapest
ZIP/Postal Code
1115
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Hungary
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Budapest
ZIP/Postal Code
1145
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Hungary
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Budapest
ZIP/Postal Code
1204
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Hungary
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Debrecen
ZIP/Postal Code
4012
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Hungary
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City
Debrecen
ZIP/Postal Code
4031
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Hungary
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City
Gyor
ZIP/Postal Code
9000
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Hungary
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Nyiregyhaza
ZIP/Postal Code
4400
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Hungary
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City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
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Research Site
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Research Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Research Site
City
Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6533 PA
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Research Site
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-402
Country
Poland
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-420
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Research Site
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Goteborg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Research Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
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Research Site
City
Ankara
ZIP/Postal Code
06100
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Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
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Research Site
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Research Site
City
Essex
ZIP/Postal Code
RM7 0AG
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United Kingdom
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Research Site
City
Liverpool
ZIP/Postal Code
L9 7AJ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE5 9RF
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Research Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE14LP
Country
United Kingdom
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Research Site
City
Stoke on Trent
ZIP/Postal Code
ST4 7LN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20737510
Citation
Gorelik L, Lerner M, Bixler S, Crossman M, Schlain B, Simon K, Pace A, Cheung A, Chen LL, Berman M, Zein F, Wilson E, Yednock T, Sandrock A, Goelz SE, Subramanyam M. Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010 Sep;68(3):295-303. doi: 10.1002/ana.22128.
Results Reference
result
PubMed Identifier
20737514
Citation
Rudick RA, O'Connor PW, Polman CH, Goodman AD, Ray SS, Griffith NM, Jurgensen SA, Gorelik L, Forrestal F, Sandrock AW, Goelz SE. Assessment of JC virus DNA in blood and urine from natalizumab-treated patients. Ann Neurol. 2010 Sep;68(3):304-10. doi: 10.1002/ana.22107.
Results Reference
result
PubMed Identifier
24898925
Citation
O'Connor P, Goodman A, Kappos L, Lublin F, Polman C, Rudick RA, Hauswirth K, Cristiano LM, Forrestal F, Duda P. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology. 2014 Jul 1;83(1):78-86. doi: 10.1212/WNL.0000000000000541. Epub 2014 Jun 4. Erratum In: Neurology. 2014 Aug 19;83(8):773.
Results Reference
result
Links:
URL
http://www.nationalmssociety.org
Description
The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.
URL
http://www.msactivesource.com
Description
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.

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Natalizumab (Tysabri) Re-Initiation of Dosing

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