Tecfidera and the Gut Microbiota

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT02471560
• Date of registration: 11/06/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Tecfidera and the Gut Microbiota TECONGUT
• Scientific title: The Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events.
• Date of first enrolment: November 6, 2015
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02471560
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Norway

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: injectable MS DMT

Drug: dimethyl fumarate

Primary Outcome(s)

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]

Secondary Outcome(s)

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 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]

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]

Secondary ID(s)

2015-001197-18

NOR-BGT-14-10665

Source(s) of Monetary Support

Please refer to primary and secondary sponsors