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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001197-18 | EudraCT Number |
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The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota. The secondary objectives of this study are as follows: To identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated patients is reflected in the gut microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dimethyl fumarate | Experimental | As prescribed by the Investigator according to the local Summary of Product Characteristics. |
|
| injectable MS DMT | Active Comparator | As prescribed by the Investigator according to the local Summary of Product Characteristics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | As per the prevailing local label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment. | Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiota composition between DMF treated participants that do or do not develop GI AEs as measured by an increase in the Gastrointestinal Symptom Rating Scale (GSRS) score. | GSRS is a self-reported questionnaire regarding GI symptoms comprising 15 items scored on a 7-point Likert scale. The 15 items can be grouped in 5 dimensions 1) abdominal pain (abdominal pain, gastric hunger pain, and nausea) 2) reflux (heartburn and acid regurgitation) 3) indigestion (borborygmus, bloating, eructation, and increased flatus) 4) diarrhea (diarrhea, loose stools, and urgency) and 5) constipation (constipation, hard stools, incomplete evacuation). A GI AE will be defined as an at least 2 point (>=2) increase from baseline in total score of any of the 5 dimensions in the GSRS. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Drammen | 3019 | Norway | |||
| Research site |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| injectable MS DMT | Drug | As described above. |
|
| Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points |
| Changes in gut microbiota composition in participants treated with DMF compared to participants treated with an alternative injectable multiple sclerosis (MS) disease modifying therapies (DMT) | Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points |
| Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs. | Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points |
| Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences. | Upon GI symptoms and week 12 |
| Haukeland |
| 5021 |
| Norway |
| Research Site | Lillehammer | 2609 | Norway |
| Research site | Lørenskog | 1478 | Norway |
| Research site | Molde | 6412 | Norway |
| Research site | Oslo | 0450 | Norway |
| Research site | Stavanger | 4011 | Norway |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |