Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participan
A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects With Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
Results by group
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)
Up to Week 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 82 Participants | 211 | |
| Dimethyl Fumarate | 71 Participants | 211 | |
| Dimethyl Fumarate | 33 Participants | 211 | |
| Dimethyl Fumarate | 22 Participants | 211 |
Dimethyl Fumarate
Dimethyl Fumarate
Dimethyl Fumarate
Dimethyl Fumarate
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)
Up to Week 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 83 Participants | 211 | |
| Dimethyl Fumarate | 72 Participants | 211 | |
| Dimethyl Fumarate | 34 Participants | 211 | |
| Dimethyl Fumarate | 26 Participants | 211 |
Dimethyl Fumarate
Dimethyl Fumarate
Dimethyl Fumarate
Dimethyl Fumarate
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Up to Week 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 5.94 units on a scale | 2.427 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 5.75 units on a scale | 2.554 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 3.53 units on a scale | 2.533 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 3.1 units on a scale | 2.568 (Standard Deviation) | 84 |
Dimethyl Fumarate
Dimethyl Fumarate
Dimethyl Fumarate
Dimethyl Fumarate
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Up to Week 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 5.93 units on a scale | 2.516 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 5.88 units on a scale | 2.614 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 3.31 units on a scale | 2.307 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 3.55 units on a scale | 2.772 (Standard Deviation) | 84 |
Dimethyl Fumarate
Dimethyl Fumarate
Dimethyl Fumarate
Dimethyl Fumarate
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Up to Week 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 38.13 percentage of days | 29.263 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 42.08 percentage of days | 27.495 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 36.98 percentage of days | 29.754 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 39.61 percentage of days | 29.197 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 48.15 percentage of days | 30.14 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 45.94 percentage of days | 27.147 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 44.33 percentage of days | 29.095 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 57.52 percentage of days | 21.998 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 52.71 percentage of days | 31.829 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 32.78 percentage of days | 26.995 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 9.20 percentage of days | 2.137 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 49.58 percentage of days | 29.547 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 53.92 percentage of days | 27.197 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 49.53 percentage of days | 32.012 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 55.31 percentage of days | 29.869 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 56.63 percentage of days | 25.764 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 44.42 percentage of days | 32.47 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 48.48 percentage of days | 35.539 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 69.78 percentage of days | 24.808 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 66.43 percentage of days | 31.4 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 41.41 percentage of days | 34.085 (Standard Deviation) | 84 |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | 41.55 percentage of days | 38.612 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 44.04 percentage of days | 41.414 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 41.67 percentage of days | 52.042 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 37.45 percentage of days | 37.388 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 69.14 percentage of days | 44.186 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 63.75 percentage of days | 31.332 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 70.42 percentage of days | 25.699 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 35.71 percentage of days | 84 | |
| Dimethyl Fumarate | 56.88 percentage of days | 40.032 (Standard Deviation) | 84 |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | 1.79 percentage of days | 2.525 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 43.27 percentage of days | 42.322 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 47.66 percentage of days | 43.191 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 82.72 percentage of days | 29.937 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 48.85 percentage of days | 50.931 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 22.12 percentage of days | 20.834 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 62.50 percentage of days | 53.033 (Standard Deviation) | 84 |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | 9.26 percentage of days | 13.095 (Standard Deviation) | 84 |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | Not reached | 84 |
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Up to Week 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 38.20 percentage of days | 30.516 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 41.29 percentage of days | 29.517 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 33.67 percentage of days | 27.31 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 39.28 percentage of days | 29.165 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 49.94 percentage of days | 33.291 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 45.65 percentage of days | 27.118 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 44.71 percentage of days | 30.374 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 55.32 percentage of days | 23.097 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 53.42 percentage of days | 31.443 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 36.92 percentage of days | 27.8 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 10.88 percentage of days | 1.924 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 51.03 percentage of days | 30.36 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 54.41 percentage of days | 29.608 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 47.84 percentage of days | 30.764 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 56.67 percentage of days | 30.711 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 58.90 percentage of days | 27.111 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 53.74 percentage of days | 32.304 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 46.43 percentage of days | 33.221 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 67.54 percentage of days | 25.296 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 69.86 percentage of days | 28.919 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 47.61 percentage of days | 47.61 (Standard Deviation) | 84 |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | 40.59 percentage of days | 37.836 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 41.59 percentage of days | 41.442 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 47.14 percentage of days | 45.781 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 38.50 percentage of days | 35.493 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 62.58 percentage of days | 45.775 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 56.33 percentage of days | 33.011 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 71.61 percentage of days | 24.587 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 35.71 percentage of days | 84 | |
| Dimethyl Fumarate | 62.24 percentage of days | 32.456 (Standard Deviation) | 84 |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | 10.00 percentage of days | 14.142 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 41.28 percentage of days | 42.466 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 44.24 percentage of days | 44.754 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 76.19 percentage of days | 41.239 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 51.99 percentage of days | 50.113 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 15.48 percentage of days | 10.178 (Standard Deviation) | 84 |
| Dimethyl Fumarate | 63.16 percentage of days | 52.103 (Standard Deviation) | 84 |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | 13.11 percentage of days | 7.655 (Standard Deviation) | 84 |
| Dimethyl Fumarate | Not reached | 84 | |
| Dimethyl Fumarate | Not reached | 84 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Dimethyl Fumarate | 211 | 5 (2.4%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)
Up to Week 12
Bladder, bowel and sexual functionPainNumber of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)
Up to Week 12
Bladder, bowel and sexual functionPainWorst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Up to Week 12
Bladder, bowel and sexual functionPainWorst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Up to Week 12
Bladder, bowel and sexual functionPainDuration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Up to Week 12
Bladder, bowel and sexual functionSafetyDuration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Up to Week 12
Bladder, bowel and sexual functionSafetyThe 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).
Other measures (6)
Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12
Week 4, Week 8, Week 12
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Up to Week 12
Bladder, bowel and sexual functionDuration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Up to Week 12
Bladder, bowel and sexual functionPercentage of Participants Who Required Dimethyl Fumarate Dose Reduction In Response To Gastrointestinal-Related Events
Up to Week 12
Percentage of Participants Who Discontinued Dimethyl Fumarate Due To Gastrointestinal-Related Treatment-Emergent Adverse Events
Up to Week 12
SafetyThe cumulative proportion of subjects who require GI symptomatic therapy
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
Key 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 Key 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 NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Jun 2014
Main results due
Feb 2016
Finished
Mar 2016
Results posted
Apr 2017