Multiple SclerosisPhase 3TERICISNCT02587195
A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
A Phase 3 study testing Teriflunomide in people with Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
Trial summary
National, multicenter study: The study consists of 3 periods: 1. A baseline visit to confirm that patient is still in CIS status. All patients will be clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to exclude MS patients according to 2010 Mc Donald's criteria. 2. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Teriflunomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesFrance
- Study dates
- 18 Dec 2015to 31 Aug 2021
- Phase
- Phase 3
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients enrolled in TOPIC study and extension of TOPIC study and currently treated in French extension of TOPIC study who did not convert into MS.
- A baseline MRI scan (performed less than 2 months before baseline Visit ) confirming that patient is still in CIS status.
Who cannot join
- Contraindication for MRI,
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease or procedure/medication making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participating in the study
- Patients with a congenital or acquired severe immunodeficiency, a history of cancer (except for basal or squamous cell skin lesions which have been surgically excised, with no evidence of metastasis), lymphoproliferative disease, or any patient who has received lymphoid irradiation
- Known history of active tuberculosis not adequately treated
- Persistent significant or severe infection
- History of drug or alcohol abuse
Show all 22Show fewer
- Patients must not have used Adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to inclusion
- Prior use within 4 weeks before inclusion or concomitant use of cholestyramine
- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate
- Prior or concomitant use of interferons, cytokine therapy, glatiramer acetate or intravenous immunoglobulins
- Prior or concomitant use of natalizumab (Tysabri®)
- Pregnant or breast-feeding women
- Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
- Women wishing to become pregnant during the course of the trial
- Patients with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
- Human immunodeficiency virus (HIV) positive patient
- Persisting elevations (confirmed by retest) of serum amylase or lipase greater than 2-fold the upper limit of normal
- Known history of chronic pancreatic disease or pancreatitis
- Liver function impairment or persisting elevations (confirmed by retest) of serum glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST), or direct bilirubin greater than 1.5-fold the upper limit of normal
- Known history of active hepatitis
- Hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin < 3.0 g/dL
- Moderate to severe impairment of renal function, as shown by serum creatinine > 133 μmol/L (or > 1.5 mg/dL)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Besançon
Besançon, 25030
CHU de Lille
Lille, 59037
CHU de Montpellier
Montpellier, 34295
CHU de Nice
Nice, 06000
CHU de Strasbourg
Strasbourg, 67098
About this study
Official title: A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
National, multicenter study:
The study consists of 3 periods:
- A baseline visit to confirm that patient is still in CIS status. All patients will be clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to exclude MS patients according to 2010 Mc Donald's criteria.
- Treatment period with timed evaluations
- Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and accelerated elimination procedure. All patients who discontinue the study drug and according to investgator's decision, will perform the accelerated elimination procedure and the post- accelerated elimination visits (at 2 and 4 weeks after the end of treatment (EOT).
- Conditions
- Multiple Sclerosis
- Being tested
- Teriflunomide
- Keywords
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriflunomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Teriflunomide | Experimental | Teriflunomide 14 mg Once Daily Receives: Drug: Teriflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event reporting
evaluation of safety and tolerability of teriflunomide 14mg per day
Measured: throughout study completion an average of 6 months
Adverse Events That Are Related to Treatment
Measured: throughout study completion an average of 6 months
Secondary outcomes (8)
Conversion based on MRI
Conversion to definite MS based on MRI data as defined by the demonstration of dissemination of MRI lesions in time (based on the 2010 revised McDonald criteria) within 3 years
Measured: throughout study completion an average of 6 months
Conversion based on Clinical evaluation
Conversion to clinically definite MS based on clinical evaluation and annualized relapse rate (ARR), defined as number of relapses per patient-year
Measured: throughout study completion an average of 6 months
Conversion based on annualized relapse rate (ARR)
Conversion to clinically definite MS based on clinical evaluation and annualized relapse rate (ARR), defined as number of relapses per patient-year
Measured: throughout study completion an average of 6 months
volume of abnormal brain tissue on MRI
Measured: 3 years
Disability progression defined as a 1.0-point increase in EDSS score
to disability progression (12 weeks), defined as a 1.0-point increase in EDSS score (or 0.5-point increase for baseline EDSS >5.5) confirmed after at least 12 weeks
Measured: confirmed after at least 12 weeks
Proportion of disability-free subjects as assessed by the EDSS
Proportion of disability-free subjects as assessed by the EDSS
Measured: throughout study completion an average of 1 year
Fatigue Impact Scale
Patient-reported fatigue based on the Fatigue Impact Scale
Measured: throughout study completion an average of 1 year
Quality of life using SF-36
Measured: throughout study completion an average of 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 Oct 2015 (estimated)
- Study start18 Dec 2015
- Primary completion31 Aug 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587195
- Sponsor's protocol ID
- 15-PP-06
- Acronym
- TERICIS
- Status last verified
- Mar 2023
- First submitted
- 22 Sep 2015
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
- ClinicalTrials.gov ID
- NCT02587195
- Acronym / sponsor ID
- TERICIS / 15-PP-06
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Oct 2015 (estimated)
- 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.
National, multicenter study:
The study consists of 3 periods:
- A baseline visit to confirm that patient is still in CIS status. All patients will be clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to exclude MS patients according to 2010 Mc Donald's criteria.
- Treatment period with timed evaluations
- Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and accelerated elimination procedure. All patients who discontinue the study drug and according to investgator's decision, will perform the accelerated elimination procedure and the post- accelerated elimination visits (at 2 and 4 weeks after the end of treatment (EOT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teriflunomide | Experimental | Drug: TeriflunomideTeriflunomide 14 mg Once Daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients enrolled in TOPIC study and extension of TOPIC study and currently treated in French extension of TOPIC study who did not convert into MS.
- A baseline MRI scan (performed less than 2 months before baseline Visit ) confirming that patient is still in CIS status.
Key exclusion criteria (22 listed)
- Contraindication for MRI,
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease or procedure/medication making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participating in the study
- Patients with a congenital or acquired severe immunodeficiency, a history of cancer (except for basal or squamous cell skin lesions which have been surgically excised, with no evidence of metastasis), lymphoproliferative disease, or any patient who has received lymphoid irradiation
- Known history of active tuberculosis not adequately treated
- Persistent significant or severe infection
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 | Drug | Teriflunomide |
Primary outcome
Adverse event reporting
Time frame: throughout study completion an average of 6 months
evaluation of safety and tolerability of teriflunomide 14mg per day
Adverse Events That Are Related to Treatment
Time frame: throughout study completion an average of 6 months
8 secondary outcomes
Conversion based on MRI
Time frame: throughout study completion an average of 6 months
Conversion based on Clinical evaluation
Time frame: throughout study completion an average of 6 months
Conversion based on annualized relapse rate (ARR)
Time frame: throughout study completion an average of 6 months
volume of abnormal brain tissue on MRI
Time frame: 3 years
Disability progression defined as a 1.0-point increase in EDSS score
Time frame: confirmed after at least 12 weeks
Proportion of disability-free subjects as assessed by the EDSS
Time frame: throughout study completion an average of 1 year
Fatigue Impact Scale
Time frame: throughout study completion an average of 1 year
Quality of life using SF-36
Time frame: throughout study completion an average of 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 22 Mar 2023.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teriflunomide in people with Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
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 2 inclusion and 22 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 event reporting (time frame: throughout study completion an average of 6 months). The study lists 2 primary outcomes in all. 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 22 Mar 2023.