A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting

Phase 1

• Conditions: MedDRA version: 19.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; Relapsing-Remitting Multiple Sclerosis; MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001656-35-AT
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-18
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1080

Inclusion Criteria

Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorizations required by local law in accordance with national and local subject privacy regulations.

Have a diagnosis of RRMS and satisfy the approved therapeutic indication for DMF (per the local DMF product information).

Must be naïve to DMF, Fumaderm®, and other compounded fumarates, and to MS therapies that are primarily prescribed second-line (e.g., natalizumab, fingolimod) and to alemtuzumab.

Are >18 years old

Have a recent (i.e., within the previous 6 months) complete blood count (CBC) that does not preclude the subject’s participation in the study, in the judgment of the Investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1080
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.

Have major comorbid conditions that preclude participation in the study, as determined by the Investigator.

Are pregnant, unless DMF is clearly needed and the potential benefit of DMF to the subjects justifies the potential risk to the fetus, in the judgment of the Investigator (in all countries except Austria). In Austria, pregnant subjects are excluded from participation in the study.

Are women of childbearing potential and are not using appropriate contraception (per the local DMF product information) as determined by the Investigator.

Women who are breastfeeding may be excluded (per the local DMF product information) at the discretion of the Investigator.

Have previously received or are receiving treatment with MS therapies primarily used second-line (e.g., natalizumab, fingolimod) or alemtuzumab, or are currently receiving and planning to continue on other disease-modifying therapies for RRMS, including but not limited to interferon ß, glatiramer acetate, teriflunomide, or laquinimod.

Are hypersensitive to the active ingredient in the DMF drug product (i.e., DMF) or to any of the excipients listed in the local DMF product information.

Current enrollment in any clinical trial or Biogen Idec-sponsored study except for the DMF Pregnancy Exposure Registry or other studies that, according to the study Medical Director, do not conflict with this study (e.g., health economics studies or local registries).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to estimate the annualized relapse rate (ARR) in subjects with RRMS who are treated with DMF over a 12-month period.<br><br>;Secondary Objective: The secondary objectives of this study in this population are to assess the impact of DMF over a 12 month period on patient-reported HRQoL outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize patient-reported adherence to DMF.;Primary end point(s): Annualized Relapse Rate (ARR);Timepoint(s) of evaluation of this end point: 12 months