Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent in accordance with national and local patient privacy regulations. Have a confirmed diagnosis of RRMS according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (see Fachinformation). Age =18 years at the time of informed consent. Naïve to DMF and fumaric acid esters. 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 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation. Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study. History of significant GI disease (e.g., irritable bowel disease, peptic ulcer disease, history of major GI surgeries), or chronic use of GI-related symptomatic therapy as determined by the Investigator (or =7 consecutive days of GI-related symptomatic therapy, e.g., loperamide hydrochloride, omeprazole, esomeprazole, lansoprazole, pantoprazole, paracetamol, acetylsalicylic acid, ranitidine, loratadine, butylscopolamine bromide, metoclopramide, domperidone, or dimethicone within the month prior to enrollment in the study). Presence of one or more major comorbidities that, in the opinion of the Investigator, may affect the outcome of the study. Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible). History of anaphylaxis or severe allergic reactions or known drug hypersensitivity. Current enrollment in any clinical trial or Biogen Idec sponsored study except 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). 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 Fachinformation precautions for use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of symptomatic therapies on GI-related events reported by subjects with RRMS initiating therapy with DMF in the clinical practice setting.;Secondary Objective: To evaluate GI-related events requiring symptomatic therapy and the role of those therapies over time To evaluate GI-related events that lead to a physician’s decision to manage the events with DMF dose modification To evaluate GI-related events that lead to DMF discontinuation after the use of symptomatic therapy;Primary end point(s): The frequency, severity, and duration of GI-related events in subjects who utilize symptomatic therapy during the 12-week Treatment Period, as measured by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) and Modified Acute Gastrointestinal Symptom Scale (MAGISS).;Timepoint(s) of evaluation of this end point: 12-weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12-weeks;Secondary end point(s): The cumulative proportion of subjects who require GI symptomatic therapy The subject-reported type, frequency, and duration of symptomatic therapies used The cumulative proportion of subjects who require DMF dose reduction in response to GI-related events The percentage of subjects who discontinue DMF due to GI-related events | — |
Countries
Germany
Contacts
Public ContactClinical Trials - Neurology
Biogen Idec Research Limited
Outcome results
None listed