A study on TeriFlunomidE for multiple sclerosis patients to understand the safety and clinical profile.

A single arm phase IV clinical trial to describe the Safety And efficacy of TeriFlunomidE in patients with relapsing forms of multiple sclerosis - SAFE trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/03/017978

Enrollment

193

Registered

2019-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G35- Multiple sclerosis

Interventions

Intervention1: NIL: NIL Intervention2: Teriflunomide 14mg tablet: 14 mg of Teriflunomide (AubagioÂ®) to be taken orally, once per day in the morning according to the approved labelling Control Interve

Eligibility

Inclusion 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

Exclusion criteria: 1. Patients with hypersensitivity to teriflunomide, leflunomide, or to any excipients in the tablets. 2. 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 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

Design outcomes

Primary

Measure	Time frame
1.Incidence, duration, severity (mild/moderate/severe), and outcome of any adverse events (AEs), serious adverse events (SAEs) during the study duration 13 monthsTimepoint: 1. 13 months	—

Secondary

Measure	Time frame
1.Annualized relapse rate, defined as number of relapses per patient-year ,TIMEPOINTS: 12 months 2. Time to first relapse, TIMEPOINTS: 12 months 3.Drug compliance (using patient diary), TIMEPOINTS: 12 months Patient diary will capture if any drug dose is missed and safety events (if any) Timepoint: 1. Timepoints: 12 months 1. TIMEPOINTS: 12 months 2. Timepoints: 12 months 3. TIMEPOINTS: 12 months Patient diary will capture if any drug dose is missed and safety events (if any)	—

Measure

Time frame

1.Annualized relapse rate, defined as number of relapses per patient-year ,TIMEPOINTS: 12 months 2. Time to first relapse, TIMEPOINTS: 12 months 3.Drug compliance (using patient diary), TIMEPOINTS: 12 months Patient diary will capture if any drug dose is missed and safety events (if any) Timepoint: 1. Timepoints: 12 months 1. TIMEPOINTS: 12 months 2. Timepoints: 12 months 3. TIMEPOINTS: 12 months Patient diary will capture if any drug dose is missed and safety events (if any)

—

Countries

India

Contacts

Public ContactMr Saurabh Naik

Sanofi Synthelabo India Private Limited

Amod.Limaye@sanofi.com91-22-28032226

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026