Natalizumab (Tysabri) Re-Initiation of Dosing (STRATA)
June 16, 2016 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, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.)
Study Type
Interventional
Enrollment (Actual)
1094
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
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Camperdown, Australia, 2050
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Heidelberg, Australia, 3084
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Parkville, Australia, 3050
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Brugge, Belgium, 8000
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Brussels, Belgium, 1070
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Charleroi, Belgium, 6000
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Diepenbeek, Belgium, 3590
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Melsbroek, Belgium, 1820
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Sijsele, Belgium, 8340
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2B5
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H IV7
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
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London, Ontario, Canada, N6A5A5
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New York, Ontario, Canada, M4N 3M5
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Ottawa, Ontario, Canada, K2G6E2
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Toronto, Ontario, Canada, M5B 1W8
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Quebec
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Gatineau, Quebec, Canada, J8Y 1W7
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H3A2B4
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Brno, Czech Republic, 625 00
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Brno, Czech Republic, 656 91
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Hradec Kralove, Czech Republic, 500 05
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Olomouc, Czech Republic, 775 20
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Ostrava, Czech Republic, 708 52
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Pardubice, Czech Republic, 532 03
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Plzen, Czech Republic, 323 00
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Praha 2, Czech Republic, 12000
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Praha 5, Czech Republic, 150 06
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Aarhus C, Denmark, 8000
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Esbjerg, Denmark, 6700
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Kobenhavn, Denmark, 2100
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Helsinki, Finland, 00290
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Tampere, Finland, 33520
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Turku, Finland, 20100
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Besancon, France, 25030
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Bordeaux, France, 33076
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Clermont-Ferrand, France, 63003
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Creteil, France, 94101
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Dijon, France, 21033
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Lille, France, 59037
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Lyon, France, 69677
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Marseille, France, 13385
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Nancy, France, 54035
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Paris, France, 75019
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Paris, France, 75651
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Rennes, France, 35033
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Strasbourg, France, 67091
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Toulouse, France, 31059
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Berlin, Germany, 13347
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Essen, Germany, 45122
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Gießen, Germany, 35385
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Hannover, Germany, 30625
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Hennigsdorf, Germany, 16761
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München, Germany, 81377
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Offenbach, Germany, 63069
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Osnabrück, Germany, 49076
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Regensburg, Germany, 93053
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Rostock, Germany, 18147
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Athens, Greece, 11527
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Budapest, Hungary, 1115
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Budapest, Hungary, 1145
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Budapest, Hungary, 1204
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Budapest, Hungary, 1021
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Debrecen, Hungary, 4012
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Debrecen, Hungary, 4031
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Gyor, Hungary, 9000
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Nyiregyhaza, Hungary, 4400
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Szekesfehervar, Hungary, 8000
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Dublin, Ireland, 4
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Jerusalem, Israel, 91120
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Tel Hashomer, Israel, 52621
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Bari, Italy, 70124
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Genova, Italy, 16132
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Milano, Italy, 20132
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Roma, Italy, 00185
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Amsterdam, Netherlands, 1081HV
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Breda, Netherlands, 4818 CK
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Hertogenbosch, Netherlands, 5211 NL
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Nieuwegein, Netherlands, 3435 CM
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Nijmegen, Netherlands, 6533 PA
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Rotterdam, Netherlands, 3015 GD
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Auckland, New Zealand, 1023
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Christchurch, New Zealand, 8011
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Białystok, Poland, 15-402
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Białystok, Poland, 15-420
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Bydgoszcz, Poland, 85-681
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Gdańsk, Poland, 80-803
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Katowice, Poland, 40-752
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Kraków, Poland, 31-530
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Lodz, Poland, 90-153
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Lublin, Poland, 20-954
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Warsaw, Poland, 02-957
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Warszawa, Poland, 02-097
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Barcelona, Spain, 08035
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Barcelona, Spain, 08907
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Málaga, Spain, 29010
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Goteborg, Sweden, 41685
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Stockholm, Sweden, 17176
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Stockholm, Sweden, 141 86
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Basel, Switzerland, 4031
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Ankara, Turkey, 06100
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Istanbul, Turkey, 34390
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Istanbul, Turkey, 34303
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Essex, United Kingdom, RM7 0AG
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Liverpool, United Kingdom, L9 7AJ
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London, United Kingdom, SW17 0QT
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London, United Kingdom, E1 1BB
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London, United Kingdom, SE5 9RF
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Newcastle Upon Tyne, United Kingdom, NE14LP
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Oxford, United Kingdom, OX3 9DU
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Sheffield, United Kingdom, S10 2JF
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Stoke on Trent, United Kingdom, ST4 7LN
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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
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.
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 |
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Experimental: Natalizumab
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression
Time Frame: up to 480 weeks
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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.
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up to 480 weeks
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Time to 48-week Confirmed EDSS Progression
Time Frame: up to 480 weeks
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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.
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up to 480 weeks
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Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0
Time Frame: Up to 480 weeks
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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.
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Up to 480 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
- 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.
Helpful Links
- The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.
- 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.
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)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
February 27, 2006
First Submitted That Met QC Criteria
February 27, 2006
First Posted (Estimate)
February 28, 2006
Study Record Updates
Last Update Posted (Estimate)
July 15, 2016
Last Update Submitted That Met QC Criteria
June 16, 2016
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Physiological Effects of Drugs
- Immunologic Factors
- Natalizumab
Other Study ID Numbers
- 101-MS-321
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.