Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT01895335
Eligibility Criteria:
Inclusion criteria:
Participants with a relapsing form of multiple sclerosis (RMS) having signed written informed consent.
Exclusion criteria:
* According to local labelling,
* Less than 18 years of age,
* Current or history of receiving teriflunomide,
* Previous treatment with leflunomide within 6 months prior to baseline,
* Participants with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN),
* Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by standard medical practice or guidelines (including skin or blood test, chest X-ray, or as appropriate per local practice),
* Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections,
* Women who were pregnant or breast-feeding,
* Female participants with a positive pregnancy test at screening or women of child-bearing potential who did not agree to use reliable contraception throughout the course of the study,
* Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study,
* Additional exclusion criteria applicable for Europe (EU) countries (in accordance with contraindications of EU summary of product characteristics \[SmPC\]):
* Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia,
* Participants with severe active infection until resolution,
* Participants with severe renal impairment undergoing dialysis, because insufficient clinical experience was available in this participant group,
* Participants with severe hypoproteinaemia, e.g. in nephrotic syndrome.
* Hypersensitivity to the active substance or to any of the excipients,
* Other additional contraindications per local labeling.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01895335
Study Brief:
Protocol Section:
NCT01895335