Clinical trials: Tecfidera
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, 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
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
Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- NCT02428218
- Testing
- dimethyl fumarate
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a…
- Trial name
- NCT00837785
- Testing
- BG00012
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)
The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from…
- Trial name
- STRATEGY (NCT02159573)
- Testing
- natalizumab, dimethyl fumarate
- Where
- 43 sites in United States
- Volunteers
- 530 people
- Sponsor
- Biogen
Healthy
BG00012 Regional Absorption Study
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying…
- Trial name
- NCT01924832
- Testing
- dimethyl fumarate
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Alternate Dosing Regimens of BG00012 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo
- Trial name
- 109HV106 (NCT01281111)
- Testing
- Dimethyl Fumarate (BG00012), Aspirin
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Biogen
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
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