Clinical trials: Tecfidera
Plaque Psoriasis
Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis
This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times…
- Trial name
- NCT01815723
- Testing
- FP187, Dimethyl fumarate
- Where
- Canada
- Sponsor
- Forward-Pharma GmbH
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants with lymphopenia.
- Trial name
- Lympho-TEC (NCT04756687)
- Testing
- Dimethyl fumarate
- Where
- 32 sites in France
- Volunteers
- 1,507 people
- Sponsor
- Biogen
Relapsing Multiple Sclerosis
A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany.
- Trial name
- AIOLOS (NCT05344469)
- Testing
- ofatumumab, glatiramer acetate, interferon β1
- Where
- 141 sites in Germany
- Volunteers
- 800 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance Imaging
Tecfidera Diffusion Tensor Imaging
The primary aim of this study is to explore the effect of dimethyl fumarate on gray matter (GM) pathology, as measured by changes in diffusion-tensor imaging (DTI) of the thalamus in patients with relapsing multiple sclerosis…
- Trial name
- DTI (NCT02686684)
- Testing
- Dimethyl fumarate
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- University at Buffalo
Relapsing Remitting Multiple Sclerosis
Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region
The purpose of this observational study is to evaluate the effectiveness, safety and health related quality of life of Generic DMF (Sclera® or Marovarex ®, Hikma) in patients undergoing routine clinical care for RRMS in MENA…
- Trial name
- NCT04468165
- Testing
- Dimethyl Fumarate (DMF)
- Where
- 6 sites in Algeria, Egypt and 1 more
- Volunteers
- 160 people
- Sponsor
- Hikma Pharmaceuticals LLC
Psoriasis
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and…
- Trial name
- NCT03255382
- Testing
- Fumaderm, risankizumab
- Where
- 23 sites in Germany
- Volunteers
- 120 people
- Sponsor
- AbbVie
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.
- Trial name
- PROTEC (NCT01930708)
- Testing
- dimethyl fumarate
- Where
- 90 sites in Austria, Belgium and 9 more
- Volunteers
- 1,114 people
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve…
- Trial name
- NCT04570670
- Testing
- monomethyl fumarate 190 mg, dimethyl fumarate 240 mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Multiple Sclerosis
Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3)…
- Trial name
- NCT02343159
- Testing
- dimethyl fumarate, Medication Event Monitoring System (MEMS), Adherence counseling
- Where
- 29 sites in United States
- Volunteers
- 84 people
- Sponsor
- Biogen
Multiple Sclerosis
Improving the Effect of Multiple Sclerosis Drugs by Chronobiology
A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a…
- Trial name
- NCT06385197
- Testing
- App randomizing dosing regimen
- Where
- Israel
- Volunteers
- 8 people
- Sponsor
- Hadassah Medical Organization
Rheumatoid Arthritis
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA.
- Trial name
- NCT00810836
- Testing
- BG00012
- Where
- 24 sites in Australia, Canada and 4 more
- Volunteers
- 153 people
- Sponsor
- Biogen
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
Multiple Sclerosis, Adherence, Medication
Relationship Between Oral DMT Burden and Adherence in MS
STATURE is a prospective observational six-arm translation multi-site study that will run for approx. 4.5 years. The primary aim is to measure treatment burden and its relationship to medication adherence across six…
- Trial name
- STATURE (NCT04676204)
- Testing
- Cladribine, Dimethyl fumarate, Fingolimod
- Where
- Australia
- Volunteers
- 323 people
- Sponsor
- Monash University
Relapsing-remitting Multiple Sclerosis (RRMS)
A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis
This is a randomized, controlled, multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of rocbrutinib (LP-168), an oral BTK inhibitor, in subjects with paramagnetic rim lesion (PRL)-positive…
- Trial name
- NCT07776743
- Testing
- Rocbrutinib, Dimethyl Fumarate
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
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
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
Effects of Dimethyl Fumarate on Cognitive Performance and Brain Abnormalities in Multiple Sclerosis.
The goal of this observational study is to evaluate the slowing/reduction of cognitive dysfunction progression and to evaluate grey matter (GM) and thalamus structural changes in Relapsing-Remitting Multiple Sclerosis (RRMS)…
- Trial name
- NCT05811949
- Testing
- Dimethyl Fumarate 240 MG [Tecfidera]
- Where
- Italy
- Volunteers
- 52 people
- Sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
Multiple Sclerosis, Relapsing-Remitting
Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple Sclerosis
This is an exploratory study, which allows analysis of multiple immune parameters derived from peripheral blood mononuclear cells (PBMCs) from patients with relapsing remitting multiple sclerosis before and during…
- Trial name
- DIMAT-MS (NCT02461069)
- Testing
- Dimethyl fumarate
- Where
- 6 sites in Germany
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- University Hospital Muenster
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
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