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Trial record 8 of 25 for:    Tysabri | Open Studies

Real-world Outcomes on Tecfidera® (BG00012, Dimethyl Fumarate) Post-Tysabri® (BG00002, Natalizumab) (STRATEGY)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT02159573
First received: May 19, 2014
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. The secondary objective is to further evaluate relapse activity, defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.


Condition Intervention
Relapsing-Remitting Multiple Sclerosis
Biological: BG00002 (Natalizumab)
Drug: BG00012 (dimethyl fumarate)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera [ Time Frame: 12 months post initiation of treatment with Tecfidera ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ARR at 12 months post-initiation of treatment with Tecfidera [ Time Frame: 12 months post initiation of treatment with Tecfidera ] [ Designated as safety issue: No ]
  • The percent of participants with MS-related hospitalization at 12 months post-initiation of treatment with Tecfidera [ Time Frame: 12 months post initiation of treatment with Tecfidera ] [ Designated as safety issue: No ]
  • The percent of participants with relapses requiring treatment with intravenous steroids [ Time Frame: 12 months post initiation of treatment with Tecfidera ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: May 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: BG00002 (Natalizumab)
    Administered as per routine clinical practice
    Other Name: Tysabri
    Drug: BG00012 (dimethyl fumarate)
    Administered as per routine clinical practice
    Other Name: Tecfidera
Detailed Description:

The study period will consist of a single time point retrospective medical chart abstraction with no required study visits or procedures. Data collection for this study is expected to last up to approximately five months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with a diagnosis of RRMS receiving at least 12 months of continuous treatment with Tysabri® monotherapy prior to initiation of Tecfidera®. Additionally, participants must have initiated treatment with Tecfidera® at least 12 months prior to enrollment into the study.

Criteria

Key Inclusion Criteria:

  • Diagnosis of RRMS per McDonald criteria
  • Received at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Note: continuous treatment with Tysabri is defined as treatment uninterrupted by other disease-modifying treatment.
  • Initiated treatment with Tecfidera at least 12 months prior to enrollment into the study
  • Patient has sufficient available medical records for data abstraction to meet the objectives of the study

Key Exclusion Criteria:

  • Diagnosed with a progressive form of MS (progressive-relapsing, primary progressive, secondary progressive)
  • Received treatment with any of the following after discontinuation of Tysabri and before initiation of treatment with Tecfidera (i.e., during washout period): interferon-beta, glatiramer acetate, fingolimod, teriflunomide, rituximab, alemtuzumab, ocrelizumab or any investigational compound for the treatment of RRMS
  • Received BG-12, or other formulations of dimethyl fumarate, or Fumaderm® or compounded fumarates at any time prior to initiation of treatment with Tecfidera
  • History of progressive multifocal leukoencephalopathy (PML) while on Tysabri or within 6 months of discontinuing treatment with Tysabri

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: NCT02159573

Contacts
Contact: Biogen Idec clinicaltrials@biogenidec.com

Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT02159573     History of Changes
Other Study ID Numbers: 109MS412, US-BGT-13-10564
Study First Received: May 19, 2014
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Dimethyl fumarate
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014