Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-03-31

Brief Summary

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The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by participants with relapsing-remitting multiple sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice setting.

The secondary objectives of this study in this study population are as follows: to evaluate gastrointestinal-related events requiring symptomatic therapy and the role of those therapies over time; to evaluate gastrointestinal-related events that lead to a physician's decision to manage the events with BG00012 dose modification; and to evaluate gastrointestinal-related events that lead to BG00012 discontinuation after the use of symptomatic therapy.

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Detailed Description

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Conditions

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Relapsing-Remitting Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dimethyl Fumarate

Dimethyl fumarate administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

capsules administered according to the prevailing product label

Interventions

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dimethyl fumarate

capsules administered according to the prevailing product label

Intervention Type DRUG

Other Intervention Names

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BG00012 Tecfidera DMF

Eligibility Criteria

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Inclusion Criteria

* Have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (dimethyl fumarate)
* Naïve to dimethyl fumarate and fumaric acid esters

Exclusion Criteria

* Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study
* History of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal-related symptomatic therapy as determined by the Investigator (or ≥ 7 consecutive days of gastrointestinal-related symptomatic therapy
* Known active malignancies
* History of anaphylaxis or severe allergic reactions or known drug hypersensitivity
* Current use of B vitamin supplements
* In the opinion of the Investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No