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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2016
• Main ID: NCT02159573
• Date of registration: 19/05/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab) STRATEGY
• Scientific 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)
• Date of first enrolment: July 2014
• Target sample size: 530
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02159573
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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 multiple sclerosis (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 BG00012, 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Biological: natalizumab

Drug: dimethyl fumarate

Primary Outcome(s)

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]

Secondary Outcome(s)

ARR at 12 months post-initiation of treatment with Tecfidera [Time Frame: 12 months post initiation of treatment with Tecfidera]

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]

The percent of participants with relapses requiring treatment with intravenous steroids [Time Frame: 12 months post initiation of treatment with Tecfidera]

Secondary ID(s)

109MS412

US-BGT-13-10564

Source(s) of Monetary Support

Please refer to primary and secondary sponsors