Clinical trials: Tecfidera
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
This is a multicenter study conducted in 2 parts: The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion…
- Trial name
- NCT01838668
- Testing
- dimethyl fumarate
- Where
- 54 sites in Czechia, Japan and 3 more
- Volunteers
- 225 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of…
- Trial name
- CONFIRM (NCT00451451)
- Testing
- BG00012, Glatiramer Acetate
- Where
- 195 sites in United States, Belarus and 26 more
- Volunteers
- 1,417 people
- Sponsor
- Biogen
Relapsing Forms of Multiple Sclerosis
Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal…
- Trial name
- RESPOND (NCT01903291)
- Testing
- dimethyl fumarate
- Where
- 62 sites in United States
- Volunteers
- 333 people
- Sponsor
- Biogen
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, Relapsing-Remitting, Relapsing-Remitting Multiple Sclerosis
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their…
- Trial name
- IMPROVE (NCT02323269)
- Testing
- dimethyl fumarate
- Where
- 10 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate
The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured by mean changes in the Fatigue Scale for Motor…
- Trial name
- TECNERGY (NCT02090348)
- Testing
- dimethyl fumarate
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis
The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting…
- Trial name
- PROMPT (NCT02472938)
- Testing
- dimethyl fumarate
- 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
Healthy Volunteers
Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.
- Trial name
- NCT01420458
- Testing
- Experimental
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Multiple Sclerosis
RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently being treated with, but are considering…
- Trial name
- RESOunD (NCT02117050)
- Testing
- Rebif®
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- EMD Serono
Healthy
A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers
The primary objective of this study is to establish the bioequivalence of the test product (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor SA) by comparison of…
- Trial name
- NCT02171208
- Testing
- dimethyl fumarate - Reference form, dimethyl fumarate - Test form
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability…
- Trial name
- NCT03093324
- Testing
- ALKS 8700, Dimethyl Fumarate
- Where
- 67 sites in United States, Germany and 1 more
- Volunteers
- 506 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- FOCUS (NCT02410200)
- Testing
- dimethyl fumarate
- Where
- 12 sites in United States, Belgium and 8 more
- Volunteers
- 22 people
- Sponsor
- Biogen
Multiple Sclerosis
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
- Trial name
- POINT (NCT02907177)
- Testing
- Ponesimod
- Where
- 119 sites in United States, Australia and 18 more
- Volunteers
- 136 people
- Sponsor
- Actelion
Psoriasis
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type…
- Trial name
- POLARIS (NCT02951533)
- Testing
- Guselkumab, Fumaric Acid Esters
- Where
- 28 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Janssen-Cilag G.m.b.H
Multiple Sclerosis
Efficacy and Safety of BG00012 in MS
Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
- Trial name
- NCT00168701
- Testing
- BG00012
- Where
- 42 sites in Czechia, Germany and 8 more
- Volunteers
- 260 people
- Sponsor
- Biogen
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
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
Psoriasis
Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.
This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are…
- Trial name
- PRIME (NCT02474082)
- Testing
- Secukinumab, Fumaric acid
- Where
- 32 sites in Germany
- Volunteers
- 202 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Forms of Multiple Sclerosis
A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses.
- Trial name
- VOYAGE (NCT07483632)
- Testing
- Diroximel Fumarate, Dimethyl Fumarate, Fingolimod
- Volunteers
- 185 people
- Sponsor
- Biogen