To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
NCT ID: NCT03856619
Last Updated: 2023-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2019-03-27
2022-05-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
NCT01487096
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
NCT00803049
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
NCT00134563
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
NCT00751881
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
NCT00622700
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Aubagio®/Teriflunomide
Single dose of Aubagio® to be taken orally, once daily in the morning
TERIFLUNOMIDE HMR1726
Pharmaceutical form: Tablet
Route of administration: Oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TERIFLUNOMIDE HMR1726
Pharmaceutical form: Tablet
Route of administration: Oral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with relapsing form of multiple sclerosis at time of screening visit.
* Signed written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigational Site Number :024
Ahmedabad, , India
Investigational Site Number :017
Bengaluru, , India
Investigational Site Number :001
Chandigarh, , India
Investigational Site Number :023
Coimbatore, , India
Investigational Site Number :007
Gurgaon, , India
Investigational Site Number :026
Gurgaon, , India
Investigational Site Number :005
Kochi, , India
Investigational Site Number :006
Kolkata, , India
Investigational Site Number :011
Lucknow, , India
Investigational Site Number :020
Ludhiana, , India
Investigational Site Number :018
Nashik, , India
Investigational Site Number :025
New Delhi, , India
Investigational Site Number :014
Pune, , India
Investigational Site Number :022
Thiruvananthapuram, , India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1205-3009
Identifier Type: OTHER
Identifier Source: secondary_id
TERIFL08918
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.