Clinical trials: Tecfidera
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
Multiple Sclerosis
A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
The primary objective of the study is to assess the efficacy of DMF in Chinese participants with RMS at Week 48. The secondary objectives of the study are to assess the efficacy and safety of DMF in Chinese participants with RMS.
- Trial name
- NCT05658484
- Testing
- Dimethyl fumarate
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Biogen
Adrenomyeloneuropathy Without Cerebral Involvement
Dimethyl Fumarate in Adrenomyeloneuropathy
The goal of this clinical trial is to determine if dimethyl fumarate is effective in treating motor problems in adults with Adrenomyeloneuropathy.
- Trial name
- NCT06513533
- Testing
- Dimethyl fumarate
- Where
- 3 sites in Spain
- Volunteers
- 40 people
- Sponsor
- Pujol, Aurora, M.D.
Relapsing-remitting Multiple Sclerosis
Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif…
- Trial name
- PROTRACT (NCT02823951)
- Testing
- Rebif, Tecfidera
- Where
- 23 sites in United States, Canada
- Volunteers
- 479 people
- Sponsor
- IMS HEALTH GmbH & Co. OHG
Healthy Volunteers
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.
- Trial name
- NCT01632449
- Testing
- Test product, Reference product
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Multiple Sclerosis
Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF).
- Trial name
- EFFECT (NCT02776072)
- Where
- 121 sites in United States, Argentina and 11 more
- Volunteers
- 2,978 people
- Sponsor
- Biogen
Healthy
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single…
- Trial name
- NCT01069913
- Testing
- BG00012
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis
The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetylsalicylic acid [ASA]) taken twice a day (BID) with dimethyl fumarate (DMF) administration or 75 mg enteric-coated ASA taken once daily…
- Trial name
- ASSURE (NCT02090413)
- Testing
- dimethyl fumarate, acetylsalicylic acid
- Where
- 21 sites in Ireland, United Kingdom
- Volunteers
- 241 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, 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
Multiple Sclerosis, Secondary Progressive
BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive…
- Trial name
- INSPIRE (NCT02430532)
- Testing
- dimethyl fumarate
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 58 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012
The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients.
- Trial name
- StarTec (NCT02579681)
- Testing
- dimethyl fumarate
- Where
- 18 sites in Italy
- Volunteers
- 221 people
- Sponsor
- Biogen
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Dimethylfumarate (DMF) in Relapsed/Refractory CLL/SLL
The purpose of the study is to investigate the safety of the investigational drug called dimethylfumarate (DMF). DMF is a type of drug called an immunomodulatory drug.
- Trial name
- NCT02784834
- Testing
- dimethyl fumarate
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Michael Choi
Multiple Sclerosis, Relapsing-Remitting
RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.
A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.
- Trial name
- RIFUND-MS (NCT02746744)
- Testing
- Rituximab, Dimethyl fumarate, Sodium Chloride solution
- Where
- 17 sites in Sweden
- Volunteers
- 200 people
- Sponsor
- Anders Svenningsson
Primary Progressive Multiple Sclerosis
Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
This study aims to evaluate safety and efficacy of dimethyl fumarate treatment in patients with primary progressive multiple sclerosis (PPMS).
- Trial name
- FUMAPMS (NCT02959658)
- Testing
- Dimethyl fumarate
- Where
- Denmark
- Volunteers
- 54 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Multiple Sclerosis
Tecfidera Slow-Titration Study
The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF [Tecfidera])-related gastrointestinal (GI) adverse…
- Trial name
- TITRATION (NCT02428231)
- Testing
- dimethyl fumarate
- Where
- 20 sites in United States, Belgium and 2 more
- Volunteers
- 62 people
- Sponsor
- Biogen
Multiple Sclerosis
Tecfidera Lymphocyte Chart Review
The primary objective of the study is to retrospectively investigate changes in lymphocyte counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on Tecfidera therapy for at least 6 months.
- Trial name
- REALIZE (NCT02519413)
- Testing
- dimethyl fumarate
- Where
- 10 sites in United States
- Volunteers
- 483 people
- Sponsor
- Biogen
Multiple Sclerosis
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS).
- Trial name
- NCT02634307
- Testing
- ALKS 8700
- Where
- 115 sites in United States, Belgium and 8 more
- Volunteers
- 1,057 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS.
- Trial name
- NCT03870763
- Testing
- Dimethyl Fumarate, Peginterferon Beta-1a
- Where
- 23 sites in United States, Colombia and 11 more
- Volunteers
- 11 people
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate
This is an open-label, multicenter, observational study evaluating GI symptoms in relapsing-remitting multiple sclerosis (RRMS) patients who switch from dimethyl fumarate (DMF) to Bafiertam®.
- Trial name
- PERSIST (NCT04925778)
- Testing
- monomethyl fumarate
- Sponsor
- Banner Life Sciences LLC