NCT03856619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2019

Typical duration for phase_4

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

3.1 years

First QC Date

February 25, 2019

Last Update Submit

April 18, 2023

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Adverse events (AEs)

    Incidence of adverse events

    1 year

Secondary Outcomes (6)

  • Annualized relapse rate

    1 year

  • First relapse

    1 year

  • Relapse free

    1 year

  • Neurological impairment/disability

    Baseline to 3 months, 6 months, 9 months and 1 year

  • Disability progression

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Aubagio®/Teriflunomide

EXPERIMENTAL

Single dose of Aubagio® to be taken orally, once daily in the morning

Drug: TERIFLUNOMIDE HMR1726

Interventions

TERIFLUNOMIDE HMR1726DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Aubagio®/Teriflunomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of patients ≥ 18 years
  • Patients with relapsing form of multiple sclerosis at time of screening visit.
  • Signed written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Investigational Site Number :024

Ahmedabad, 380054, India

Location

Investigational Site Number :017

Bengaluru, 560054, India

Location

Investigational Site Number :001

Chandigarh, 160012, India

Location

Investigational Site Number :023

Coimbatore, India

Location

Investigational Site Number :007

Gūrgaon, 122001, India

Location

Investigational Site Number :026

Gūrgaon, India

Location

Investigational Site Number :005

Kochi, 682041, India

Location

Investigational Site Number :006

Kolkata, 700068, India

Location

Investigational Site Number :011

Lucknow, 226003, India

Location

Investigational Site Number :020

Ludhiana, 141001, India

Location

Investigational Site Number :018

Nashik, 422001, India

Location

Investigational Site Number :025

New Delhi, India

Location

Investigational Site Number :014

Pune, 411004, India

Location

Investigational Site Number :022

Thiruvananthapuram, 695011, India

Location

MeSH Terms

Interventions

teriflunomide

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

March 27, 2019

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Locations

IN(14)