Multiple Sclerosis, Relapsing-RemittingPhase 4TECONGUTNCT02471560
Tecfidera and the Gut Microbiota
A Phase 4 study testing dimethyl fumarate and injectable MS DMT in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 7 sites in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- dimethyl fumarate and injectable MS DMT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 7 sitesNorway
- Study dates
- 6 Nov 2015to 12 Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.
- Female subjects of childbearing potential who are not surgically sterile must practice effective contraception according to the summary of product characteristics (SPC) during their participation in the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Who cannot join
- Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
- Antibiotic treatment in the last month prior to study entry.
- Scheduled alteration of diet, including the use of probiotics.
- NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Research site
Drammen, 3019
Research site
Haukeland, 5021
Research Site
Lillehammer, 2609
Research site
Lørenskog, 1478
Research site
Molde, 6412
Research site
Oslo, 0450
Research site
Stavanger, 4011
About this study
Official title: The Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events.
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- dimethyl fumarate, injectable MS DMT
- Keywords
- Microbiota, DMF, Gastro intestinal, MS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl fumarateDrug
Also called DMF, Tecfidera, BG00012
As per the prevailing local label.
injectable MS DMTDrug
As described above.
| Study group | Role | What they receive |
|---|---|---|
| dimethyl fumarate | Experimental | As prescribed by the Investigator according to the local Summary of Product Characteristics. Receives: Drug: dimethyl fumarate |
| injectable MS DMT | Active comparator | As prescribed by the Investigator according to the local Summary of Product Characteristics. Receives: Drug: injectable MS DMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.
Measured: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Upon GI symptoms and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start6 Nov 2015
- Primary completion12 Jun 2017
- Study completion12 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471560
- Sponsor's protocol ID
- NOR-BGT-14-10665
- Other IDs
- 2015-001197-18, 2015
- Acronym
- TECONGUT
- Status last verified
- Sep 2021
- First submitted
- 11 Jun 2015
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events.
- ClinicalTrials.gov ID
- NCT02471560
- Acronym / sponsor ID
- TECONGUT / NOR-BGT-14-10665
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Microbiota, DMF, Gastro intestinal, MS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2015 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dimethyl fumarate | Experimental | Drug: dimethyl fumarateAs prescribed by the Investigator according to the local Summary of Product Characteristics. |
| injectable MS DMT | Active comparator | Drug: injectable MS DMTAs prescribed by the Investigator according to the local Summary of Product Characteristics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.
- Female subjects of childbearing potential who are not surgically sterile must practice effective contraception according to the summary of product characteristics (SPC) during their participation in the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Key exclusion criteria (4 listed)
- Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
- Antibiotic treatment in the last month prior to study entry.
- Scheduled alteration of diet, including the use of probiotics.
- NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dimethyl fumarateAlso: DMF, Tecfidera, BG00012As per the prevailing local label. | Drug | dimethyl fumarate |
| injectable MS DMTAs described above. | Drug | injectable MS DMT |
Primary outcome
Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.
Time frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
4 secondary outcomes
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Upon GI symptoms and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dimethyl fumarate and injectable MS DMT in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 7 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment. (time frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.