E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-Remitting Multiple Sclerosis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029205 |
E.1.2 | Term | Nervous system disorders |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 25 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS: The end of study is last subject, last visit for final collection of data for the primary outcome (i.e. the safety follow-up visit). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |