Clinical trials: Tecfidera
Multiple Sclerosis, Relapsing-Remitting
Tecfidera and the Gut Microbiota
The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota.
- Trial name
- TECONGUT (NCT02471560)
- Testing
- dimethyl fumarate, injectable MS DMT
- Where
- 7 sites in Norway
- Volunteers
- 36 people
- Sponsor
- Biogen
Multiple Sclerosis
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl…
- Trial name
- MITIGATE (NCT02410278)
- Testing
- dimethyl fumarate, montelukast
- Where
- 50 sites in United States
- Volunteers
- 102 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- NCT02525874
- Testing
- dimethyl fumarate
- Where
- 34 sites in United States, Belgium and 5 more
- Volunteers
- 218 people
- Sponsor
- Biogen
Plaque Psoriasis
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment
The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.
- Trial name
- NCT02634801
- Testing
- Fumaric Acid Esters, Methotrexate, Ixekizumab
- Where
- 21 sites in Germany
- Volunteers
- 162 people
- Sponsor
- Eli Lilly and Company
RRMS
Study to Assess Resource Utilization and Quality of Life of Patients With RRMS Treated With Tecfidera in Greece
This is a non interventional, multicenter clinical trial, in adult patients receiving Tecfidera per approved SmPC and routine clinical practice.
- Trial name
- FIDELITY (NCT03101735)
- Testing
- Dimethyl Fumarate (DMF)
- Where
- Greece
- Volunteers
- 455 people
- Sponsor
- Genesis Pharma CNS & Specialty
Multiple Sclerosis, Relapsing-Remitting
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200).
- Trial name
- NCT02555215
- Testing
- dimethyl fumarate
- Where
- 12 sites in United States, Belgium and 8 more
- Volunteers
- 20 people
- Sponsor
- Biogen
Healthy
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate
The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events…
- Trial name
- NCT01568112
- Testing
- BG00012 (dimethyl fumarate), ASA
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in…
- Trial name
- DEFINE (NCT00420212)
- Testing
- BG00012
- Where
- 159 sites in United States, Australia and 27 more
- Volunteers
- 1,234 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting…
- Trial name
- EXPLORE (NCT01156311)
- Testing
- dimethyl fumarate
- Where
- 16 sites in United States
- Volunteers
- 108 people
- Sponsor
- Biogen
Relapsing-remitting Multiple Sclerosis
A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis
The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis.
- Trial name
- NCT02975349
- Testing
- Evobrutinib, Tecfidera
- Where
- 56 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 267 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Plaque Psoriasis
Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy
The purpose of this study is to assess the efficacy, safety and tolerability of Tildrakizumab in moderate-to-severe plaque psoriasis participants who are non-responder to Dimethyl fumarate (DMF) at Week 16.
- Trial name
- TRANSITION (NCT04263610)
- Testing
- Dimethyl fumarate (DMF) standard scheme, Dimethyl fumarate (DMF) simplified scheme, Tildrakizumab
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 190 people
- Sponsor
- Almirall, S.A.
Multiple Sclerosis
Dimethyl Fumarate (DMF) Observational Study
The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and…
- Trial name
- ESTEEM (NCT02047097)
- Testing
- dimethyl fumarate
- Where
- 468 sites in United States, Argentina and 20 more
- Volunteers
- 5,487 people
- Sponsor
- Biogen