teriflunomide HMR1726
DrugPharmaceutical form: Tablet
Route of administration: Oral
NCT Number: NCT03856619
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Investigational Site Number :024, Ahmedabad, India
The study duration is one year; post treatment safety follow up visit will be conducted 4 weeks after the patient takes the last dose of teriflunomide
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form: Tablet
Route of administration: Oral
Time frame: 1 year
Incidence of adverse events
Time frame: 1 year
Number of relapses per patient-year
Time frame: 1 year
Time to first relapse
Time frame: 1 year
Proportion of patients who are relapse free
Time frame: Baseline to 3 months, 6 months, 9 months and 1 year
Expanded Disability Status Scale (EDSS) will be used to compare disability from baseline. The EDSS ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Time frame: 1 year
Proportion of patients free of disability progression
Time frame: 1 year
Percentage of patients who are treatment compliant assessed using patient diary
Sanofi
Industry
A Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
Acronym: SAFE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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