SAFE
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
What it measured
Main measures
Adverse events (AEs)
1 year
Safety
Other measures (6)
Annualized relapse rate
1 year
RelapsesFirst relapse
1 year
RelapsesRelapse free
1 year
RelapsesNeurological impairment/disability
Baseline to 3 months, 6 months, 9 months and 1 year
Disability progressionDisability progression
1 year
Disability progressionDrug compliance
1 year
Who could take part
Relapsing MS · 18 and over
Inclusion criteria: * Age of patients ≥ 18 years * Patients with relapsing form of multiple sclerosis at time of screening visit. * Signed written informed consent. Exclusion criteria: * Patients with hypersensitivity to teriflunomide, leflunomide, or to any excipients in the tablets. * Liver function impairment or persisting elevations of serum glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST), greater than two times the upper limit of normal (ULN) during screening visit. * Known history of pre-existing acute or chronic liver disease. * Patients with significantly (as per Investigator's discretion) impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia. * Known history of severe immunodeficiency, acute or severe active infections. * Female patients with a positive pregnancy test at screening or women of child-bearing potential who do not agree to use effective methods of contraception throughout the course of the study. * Male patients unwilling to use reliable contraception during the course of the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Primary Objective: To describe the safety of teriflunomide in patients with relapsing forms of multiple sclerosis. Secondary Objective: To describe the efficacy of teriflunomide in patients with relapsing forms of multiple sclerosis.
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History
Started
Mar 2019
Main results due
May 2022
Finished
May 2022
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