Relapsing Multiple SclerosisPhase 4SAFENCT03856619
To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
A Phase 4 study testing TERIFLUNOMIDE HMR1726 in people with Relapsing Multiple Sclerosis, run by Sanofi at 14 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- TERIFLUNOMIDE HMR1726
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 14 sitesIndia
- Study dates
- 27 Mar 2019to 13 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of patients ≥ 18 years
- Patients with relapsing form of multiple sclerosis at time of screening visit.
- Signed written informed consent.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
India14 sites
Investigational Site Number :024
Ahmedabad, 380054
Investigational Site Number :017
Bengaluru, 560054
Investigational Site Number :001
Chandigarh, 160012
Investigational Site Number :023
Coimbatore
Investigational Site Number :007
Gūrgaon, 122001
Investigational Site Number :026
Gūrgaon
Investigational Site Number :005
Kochi, 682041
Investigational Site Number :006
Kolkata, 700068
Investigational Site Number :011
Lucknow, 226003
Investigational Site Number :020
Ludhiana, 141001
Investigational Site Number :018
Nashik, 422001
Investigational Site Number :025
New Delhi
Investigational Site Number :014
Pune, 411004
Investigational Site Number :022
Thiruvananthapuram, 695011
About this study
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
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.
Read the 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
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- TERIFLUNOMIDE HMR1726
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TERIFLUNOMIDE HMR1726Drug
Pharmaceutical form: Tablet
Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Aubagio®/Teriflunomide | Experimental | Single dose of Aubagio® to be taken orally, once daily in the morning Receives: Drug: TERIFLUNOMIDE HMR1726 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence of adverse events
Measured: 1 year
Secondary outcomes (6)
Annualized relapse rate
Number of relapses per patient-year
Measured: 1 year
First relapse
Time to first relapse
Measured: 1 year
Relapse free
Proportion of patients who are relapse free
Measured: 1 year
Neurological impairment/disability
Expanded Disability Status Scale (EDSS) will be used to compare disability from baseline. The EDSS ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: Baseline to 3 months, 6 months, 9 months and 1 year
Disability progression
Proportion of patients free of disability progression
Measured: 1 year
Drug compliance
Percentage of patients who are treatment compliant assessed using patient diary
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start27 Mar 2019
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856619
- Sponsor's protocol ID
- TERIFL08918
- Other IDs
- U1111-1205-3009
- Acronym
- SAFE
- Status last verified
- Apr 2023
- First submitted
- 25 Feb 2019
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03856619
- Acronym / sponsor ID
- SAFE / TERIFL08918
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aubagio®/Teriflunomide | Experimental | Drug: TERIFLUNOMIDE HMR1726Single dose of Aubagio® to be taken orally, once daily in the morning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of patients ≥ 18 years
- Patients with relapsing form of multiple sclerosis at time of screening visit.
- Signed written informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TERIFLUNOMIDE HMR1726Pharmaceutical form: Tablet Route of administration: Oral | Drug | Aubagio®/Teriflunomide |
Primary outcome
Adverse events (AEs)
Time frame: 1 year
Incidence of adverse events
6 secondary outcomes
Annualized relapse rate
Time frame: 1 year
First relapse
Time frame: 1 year
Relapse free
Time frame: 1 year
Neurological impairment/disability
Time frame: Baseline to 3 months, 6 months, 9 months and 1 year
Disability progression
Time frame: 1 year
Drug compliance
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TERIFLUNOMIDE HMR1726 in people with Relapsing Multiple Sclerosis, run by Sanofi at 14 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.