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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1094

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
      • Camperdown, Australia, 2050
        • Research Site
      • Heidelberg, Australia, 3084
        • Research Site
      • Parkville, Australia, 3050
        • Research Site
  • Belgium
      • 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
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H IV7
        • Research Site
    • Ontario
      • 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
        • Research Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 1W7
        • Research Site
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Research Site
      • Montreal, Quebec, Canada, H3A2B4
        • Research Site
  • Czech Republic
      • 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
        • Research Site
  • Denmark
      • Aarhus C, Denmark, 8000
        • Research Site
      • Esbjerg, Denmark, 6700
        • Research Site
      • Kobenhavn, Denmark, 2100
        • Research Site
  • Finland
      • Helsinki, Finland, 00290
        • Research Site
      • Tampere, Finland, 33520
        • Research Site
      • Turku, Finland, 20100
        • Research Site
  • France
      • 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
        • Research Site
  • Germany
      • 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
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
  • Hungary
      • Budapest, Hungary, 1115
        • Research Site
      • Budapest, Hungary, 1145
        • Research Site
      • Budapest, Hungary, 1204
        • Research Site
      • Budapest, Hungary, 1021
        • 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
        • Research Site
  • Ireland
      • Dublin, Ireland, 4
        • Research Site
  • Israel
      • Jerusalem, Israel, 91120
        • Research Site
      • Tel Hashomer, Israel, 52621
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Genova, Italy, 16132
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Roma, Italy, 00185
        • Research Site
  • Netherlands
      • 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
        • Research Site
  • New Zealand
      • Auckland, New Zealand, 1023
        • Research Site
      • Christchurch, New Zealand, 8011
        • Research Site
  • Poland
      • 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
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08907
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
  • Sweden
      • Goteborg, Sweden, 41685
        • Research Site
      • Stockholm, Sweden, 17176
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Research Site
  • Turkey
      • Ankara, Turkey, 06100
        • Research Site
      • Istanbul, Turkey, 34390
        • Research Site
      • Istanbul, Turkey, 34303
        • Research Site
  • United Kingdom
      • Essex, United Kingdom, RM7 0AG
        • Research Site
      • Liverpool, United Kingdom, L9 7AJ
        • Research Site
      • London, United Kingdom, SW17 0QT
        • Research Site
      • London, United Kingdom, E1 1BB
        • Research Site
      • London, United Kingdom, SE5 9RF
        • 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
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Natalizumab
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
Drug: Natalizumab
Other Names:
  • Tysabri (BG00002)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression
Time Frame: up to 480 weeks
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.
up to 480 weeks
Time to 48-week Confirmed EDSS Progression
Time Frame: up to 480 weeks
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.
up to 480 weeks
Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0
Time Frame: Up to 480 weeks
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.
Up to 480 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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