Relapsing Remitting Multiple SclerosisNCT02490982
Teriflunomide Observational Effectiveness Study
An observational study of Relapsing Remitting Multiple Sclerosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The main goal of this investigator-initiated study is to evaluate the effectiveness and efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated in regular practice, over a period of at least two years, in the regular setting of a Multiple Sclerosis Clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Teriflunomide
- Type of treatment
- Pill or oral medicine
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to 28 Jun 2021
- Phase
- Observational
- 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
Study population: Relapsing Remitting Multiple Sclerosis patients followed at three MS Clinics.
Who may be able to join
- Consenting Relapsing Remitting Multiple Sclerosis adults with an Expanded Disability Status Scale (EDSS) score ≤ 5.0 who have been prescribed Teriflunomide and who agree to follow study procedures.
Who cannot join
- Primary progressive or secondary progressive Multiple Sclerosis without relapses; other diseases that may confound evaluation of outcomes; other exclusion as per product monograph; and women contemplating pregnancy or actually pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of this investigator-initiated study is to evaluate the effectiveness and efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated in regular practice, over a period of at least two years, in the regular setting of a Multiple Sclerosis Clinic.
Read the detailed description
Consenting adult RRMS patients, meeting all inclusion criteria and who have been prescribed Teriflunomide by their treating physician will be asked to complete questionnaires on quality of life (QoL), fatigue, and employment.
The study will include 300 participants from three Multiple Sclerosis (MS) Clinics. Disease and magnetic resonance imaging (MRI) activity, blood tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), complete blood count (CBC)), drug compliance, side effects, toxicity, will be monitored.
MS patients never treated with a disease modifying drug (DMD) and MS patients previously exposed to another DMD will be included. Some would have been on a single medication, while others would have been treated with two or more medications.
The results of the study will provide the patient-perceived global impacts of Teriflunomide on the patient's overall quality of life.
These results will also guide the physician in giving a treatment that will be adapted to the patient's major concerns.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Teriflunomide
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriflunomideDrug
Also called Aubagio
The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients.
| Study group | Role | What they receive |
|---|---|---|
| Teriflunomide | Patient-reported outcomes and clinical assessment Receives: Drug: Teriflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported outcome (PRO) scores
Change on patient-reported outcome measures, from baseline score and at each visit.
Measured: one year
Secondary outcomes (1)
Disease activity - Composite measure
Change in the annualized relapse-rate and the Expanded Disability Status Scale (EDSS) over the two year period.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Montreal Neurological Institute and Hospital
- Responsible party
- Principal investigator, Pierre Duquette, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- Pierre Duquette, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490982
- Sponsor's protocol ID
- CE15.016
- Status last verified
- Aug 2021
- First submitted
- 26 Jun 2015
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP, Benzerdjeb H, Truffinet P, Wang L, Miller A, Freedman MS; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303. doi: 10.1056/NEJMoa1014656.
PubMed 21991951Rush AJ. The role of efficacy and effectiveness trials. World Psychiatry. 2009 Feb;8(1):34-5. doi: 10.1002/j.2051-5545.2009.tb00206.x. No abstract available.
PubMed 19293957Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct;2(4):137-44. doi: 10.4103/2229-3485.86879.
PubMed 22145124Basch E. Toward patient-centered drug development in oncology. N Engl J Med. 2013 Aug 1;369(5):397-400. doi: 10.1056/NEJMp1114649. Epub 2013 Jul 3. No abstract available.
PubMed 23822654Nortvedt MW, Riise T. The use of quality of life measures in multiple sclerosis research. Mult Scler. 2003 Feb;9(1):63-72. doi: 10.1191/1352458503ms871oa.
PubMed 12617271Teriflunomide (Aubagio) (14 mg Film-coated Tablet): Teriflunomide is Indicated as Monotherapy for the Treatment of Patients with Relapsing-Remitting Multiple Sclerosis to Reduce the Frequency of Clinical Exacerbations and to Delay the Accumulation of Physical Disability [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK253634/
PubMed 25411660
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teriflunomide Observational Effectiveness Study
- ClinicalTrials.gov ID
- NCT02490982
- Acronym / sponsor ID
- CE15.016
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Montreal Neurological Institute and Hospital
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 7 Jul 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.
The main goal of this investigator-initiated study is to evaluate the effectiveness and efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated in regular practice, over a period of at least two years, in the regular setting of a Multiple Sclerosis Clinic.
Detailed description
Consenting adult RRMS patients, meeting all inclusion criteria and who have been prescribed Teriflunomide by their treating physician will be asked to complete questionnaires on quality of life (QoL), fatigue, and employment.
The study will include 300 participants from three Multiple Sclerosis (MS) Clinics. Disease and magnetic resonance imaging (MRI) activity, blood tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), complete blood count (CBC)), drug compliance, side effects, toxicity, will be monitored.
MS patients never treated with a disease modifying drug (DMD) and MS patients previously exposed to another DMD will be included. Some would have been on a single medication, while others would have been treated with two or more medications.
The results of the study will provide the patient-perceived global impacts of Teriflunomide on the patient's overall quality of life.
These results will also guide the physician in giving a treatment that will be adapted to the patient's major concerns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teriflunomide | – | Drug: TeriflunomidePatient-reported outcomes and clinical assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relapsing Remitting Multiple Sclerosis patients followed at three MS Clinics.
Key inclusion criteria (1 listed)
- Consenting Relapsing Remitting Multiple Sclerosis adults with an Expanded Disability Status Scale (EDSS) score ≤ 5.0 who have been prescribed Teriflunomide and who agree to follow study procedures.
Key exclusion criteria (1 listed)
- Primary progressive or secondary progressive Multiple Sclerosis without relapses; other diseases that may confound evaluation of outcomes; other exclusion as per product monograph; and women contemplating pregnancy or actually pregnant.
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 |
|---|---|---|
| TeriflunomideAlso: AubagioThe prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients. | Drug | Teriflunomide |
Primary outcome
Patient-reported outcome (PRO) scores
Time frame: one year
Change on patient-reported outcome measures, from baseline score and at each visit.
1 secondary outcome
Disease activity - Composite measure
Time frame: one 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 18 Aug 2021.
- Background: PubMed 21991951O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP, Benzerdjeb H, Truffinet P, Wang L, Miller A, Freedman MS; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303. doi: 10.1056/NEJMoa1014656.
- Background: PubMed 19293957Rush AJ. The role of efficacy and effectiveness trials. World Psychiatry. 2009 Feb;8(1):34-5. doi: 10.1002/j.2051-5545.2009.tb00206.x. No abstract available.
- Background: PubMed 22145124Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct;2(4):137-44. doi: 10.4103/2229-3485.86879.
- Background: PubMed 23822654Basch E. Toward patient-centered drug development in oncology. N Engl J Med. 2013 Aug 1;369(5):397-400. doi: 10.1056/NEJMp1114649. Epub 2013 Jul 3. No abstract available.
- Background: PubMed 12617271Nortvedt MW, Riise T. The use of quality of life measures in multiple sclerosis research. Mult Scler. 2003 Feb;9(1):63-72. doi: 10.1191/1352458503ms871oa.
- Background: PubMed 25411660Teriflunomide (Aubagio) (14 mg Film-coated Tablet): Teriflunomide is Indicated as Monotherapy for the Treatment of Patients with Relapsing-Remitting Multiple Sclerosis to Reduce the Frequency of Clinical Exacerbations and to Delay the Accumulation of Physical Disability [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK253634/
- Individual participant dataSharing planned: No
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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.
Pierre Duquette, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 inclusion and 1 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
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?
Patient-reported outcome (PRO) scores (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490982, which also lists 6 linked publications.
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 18 Aug 2021.