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To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis

NCT03856619

CompletedPhase 4

Sponsor: Sanofi

Conditions: Relapsing Multiple Sclerosis

Interventions: TERIFLUNOMIDE HMR1726

Countries: India

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (14)
  • Ahmedabad, India
  • Bengaluru, India
  • Chandigarh, India
  • Coimbatore, India
  • Gurgaon, India
  • Gurgaon, India
  • Kochi, India
  • Kolkata, India
  • Lucknow, India
  • Ludhiana, India
  • Nashik, India
  • New Delhi, India
  • Pune, India
  • Thiruvananthapuram, India