Clinical trial NCT03856619: To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
Official title: A Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

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.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: 1 year
Secondary outcomes:
measure: Annualized relapse rate
timeFrame: 1 year
measure: First relapse
timeFrame: 1 year
measure: Relapse free
timeFrame: 1 year
measure: Neurological impairment/disability
timeFrame: Baseline to 3 months, 6 months, 9 months and 1 year
measure: Disability progression
timeFrame: 1 year
measure: Drug compliance
timeFrame: 1 year
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Investigational Site Number :024
city: Bengaluru
country: India
facility: Investigational Site Number :017
city: Chandigarh
country: India
facility: Investigational Site Number :001
city: Coimbatore
country: India
facility: Investigational Site Number :023
city: Gurgaon
country: India
facility: Investigational Site Number :007
city: Gurgaon
country: India
facility: Investigational Site Number :026
city: Kochi
country: India
facility: Investigational Site Number :005
city: Kolkata
country: India
facility: Investigational Site Number :006
city: Lucknow
country: India
facility: Investigational Site Number :011
city: Ludhiana
country: India
facility: Investigational Site Number :020
city: Nashik
country: India
facility: Investigational Site Number :018
city: New Delhi
country: India
facility: Investigational Site Number :025
city: Pune
country: India
facility: Investigational Site Number :014
city: Thiruvananthapuram
country: India
facility: Investigational Site Number :022
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: