Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00297232
First received: February 27, 2006
Last updated: June 16, 2016
Last verified: May 2015
  Purpose
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.

Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: Natalizumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression [ Time Frame: up to 480 weeks ] [ Designated as safety issue: No ]
    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 Frame: up to 480 weeks ] [ Designated as safety issue: No ]
    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 Frame: Up to 480 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 1094
Study Start Date: March 2006
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natalizumab
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
Drug: Natalizumab
Other Name: Tysabri (BG00002)

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.)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297232

  Hide Study Locations
Locations
Australia
Research Site
Camperdown, Australia, 2050
Research Site
Heidelberg, Australia, 3084
Research Site
Parkville, Australia, 3050
Belgium
Research Site
Brugge, Belgium, 8000
Research Site
Brussels, Belgium, 1070
Research Site
Charleroi, Belgium, 6000
Research Site
Diepenbeek, Belgium, 3590
Research Site
Melsbroek, Belgium, 1820
Research Site
Sijsele, Belgium, 8340
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H IV7
Canada, Ontario
Research Site
Kingston, Ontario, Canada, K7L 2V7
Research Site
London, Ontario, Canada, N6A5A5
Research Site
New York, Ontario, Canada, M4N 3M5
Research Site
Ottawa, Ontario, Canada, K2G6E2
Research Site
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Research Site
Gatineau, Quebec, Canada, J8Y 1W7
Research Site
Greenfield Park, Quebec, Canada, J4V 2H1
Research Site
Montreal, Quebec, Canada, H3A2B4
Czech Republic
Research Site
Brno, Czech Republic, 625 00
Research Site
Brno, Czech Republic, 656 91
Research Site
Hradec Kralove, Czech Republic, 500 05
Research Site
Olomouc, Czech Republic, 775 20
Research Site
Ostrava, Czech Republic, 708 52
Research Site
Pardubice, Czech Republic, 532 03
Research Site
Plzen, Czech Republic, 323 00
Research Site
Praha 2, Czech Republic, 12000
Research Site
Praha 5, Czech Republic, 150 06
Denmark
Research Site
Aarhus C, Denmark, 8000
Research Site
Esbjerg, Denmark, 6700
Research Site
Kobenhavn, Denmark, 2100
Finland
Research Site
Helsinki, Finland, 00290
Research Site
Tampere, Finland, 33520
Research Site
Turku, Finland, 20100
France
Research Site
Besancon, France, 25030
Research Site
Bordeaux, France, 33076
Research Site
Clermont-Ferrand, France, 63003
Research Site
Creteil, France, 94101
Research Site
Dijon, France, 21033
Research Site
Lille, France, 59037
Research Site
Lyon, France, 69677
Research Site
Marseille, France, 13385
Research Site
Nancy, France, 54035
Research Site
Paris, France, 75019
Research Site
Paris, France, 75651
Research Site
Rennes, France, 35033
Research Site
Strasbourg, France, 67091
Research Site
Toulouse, France, 31059
Germany
Research Site
Berlin, Germany, 13347
Research Site
Essen, Germany, 45122
Research Site
Gießen, Germany, 35385
Research Site
Hannover, Germany, 30625
Research Site
Hennigsdorf, Germany, 16761
Research Site
München, Germany, 81377
Research Site
Offenbach, Germany, 63069
Research Site
Osnabrück, Germany, 49076
Research Site
Regensburg, Germany, 93053
Research Site
Rostock, Germany, 18147
Greece
Research Site
Athens, Greece, 11527
Hungary
Research Site
Budapest, Hungary, 1021
Research Site
Budapest, Hungary, 1115
Research Site
Budapest, Hungary, 1145
Research Site
Budapest, Hungary, 1204
Research Site
Debrecen, Hungary, 4012
Research Site
Debrecen, Hungary, 4031
Research Site
Gyor, Hungary, 9000
Research Site
Nyiregyhaza, Hungary, 4400
Research Site
Szekesfehervar, Hungary, 8000
Ireland
Research Site
Dublin, Ireland, 4
Israel
Research Site
Jerusalem, Israel, 91120
Research Site
Tel Hashomer, Israel, 52621
Italy
Research Site
Bari, Italy, 70124
Research Site
Genova, Italy, 16132
Research Site
Milano, Italy, 20132
Research Site
Roma, Italy, 00185
Netherlands
Research Site
Amsterdam, Netherlands, 1081HV
Research Site
Breda, Netherlands, 4818 CK
Research Site
Hertogenbosch, Netherlands, 5211 NL
Research Site
Nieuwegein, Netherlands, 3435 CM
Research Site
Nijmegen, Netherlands, 6533 PA
Research Site
Rotterdam, Netherlands, 3015 GD
New Zealand
Research Site
Auckland, New Zealand, 1023
Research Site
Christchurch, New Zealand, 8011
Poland
Research Site
Białystok, Poland, 15-402
Research Site
Białystok, Poland, 15-420
Research Site
Bydgoszcz, Poland, 85-681
Research Site
Gdańsk, Poland, 80-803
Research Site
Katowice, Poland, 40-752
Research Site
Kraków, Poland, 31-530
Research Site
Lodz, Poland, 90-153
Research Site
Lublin, Poland, 20-954
Research Site
Warsaw, Poland, 02-957
Research Site
Warszawa, Poland, 02-097
Spain
Research Site
Barcelona, Spain, 08035
Research Site
Barcelona, Spain, 08907
Research Site
Málaga, Spain, 29010
Sweden
Research Site
Goteborg, Sweden, 41685
Research Site
Stockholm, Sweden, 141 86
Research Site
Stockholm, Sweden, 17176
Switzerland
Research Site
Basel, Switzerland, 4031
Turkey
Research Site
Ankara, Turkey, 06100
Research Site
Istanbul, Turkey, 34303
Research Site
Istanbul, Turkey, 34390
United Kingdom
Research Site
Essex, United Kingdom, RM7 0AG
Research Site
Liverpool, United Kingdom, L9 7AJ
Research Site
London, United Kingdom, E1 1BB
Research Site
London, United Kingdom, SE5 9RF
Research Site
London, United Kingdom, SW17 0QT
Research Site
Newcastle Upon Tyne, United Kingdom, NE14LP
Research Site
Oxford, United Kingdom, OX3 9DU
Research Site
Sheffield, United Kingdom, S10 2JF
Research Site
Stoke on Trent, United Kingdom, ST4 7LN
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Additional Information:
Publications:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00297232     History of Changes
Other Study ID Numbers: 101-MS-321 
Study First Received: February 27, 2006
Results First Received: April 21, 2015
Last Updated: June 16, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Italy: Ethics Committee
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Ireland: Irish Medicines Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
Spain: Spanish Agency of Medicines
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Sweden: Medical Products Agency
Hungary: National Institute of Pharmacy
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ethics Commission
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Finland: Finnish Medicines Agency
Turkey: Ministry of Health
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Biogen:
Multiple Sclerosis
MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016