Multiple SclerosisPhase 2NCT00228163
Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
A Phase 2 study testing teriflunomide (HMR1726) in people with Multiple Sclerosis, run by Sanofi at 16 sites in 2 countries.
Trial summary
The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 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
- 147 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Jan 2002to Jan 2015
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Satisfactorily completion of HMR1726D/2001 study with respect to safety.
- If female subject, non-childbearing potential or child bearing potential with adequate contraception.
- Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment.
- Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study.
- Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study.
- Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of clinically definite MS.
- Willingness to participate in a long-term safety and efficacy trial.
Who cannot join
- Subject who did not complete HMR 1726D/2001 study for safety reasons.
- Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease.
- Pregnancy.
- Breast-feeding.
- Wish to parent.
- Likelihood of requiring treatment during the study period with drugs not permitted.
Show all 10Show fewer
- Disallowed therapies such asw immunomodulators, immunosuppressants.
- Recent history of drug or alcohol abuse.
- Liver function impairment.
- Abnormal mental conditions.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Canada10 sites
Investigational Site Number 16
Calgary, T2N 2T9
Investigational Site Number 10
Halifax, B3H 1V7
Investigational Site Number 15
London, N6A 5A5
Investigational Site Number 12
Montreal, H2L 4M1
Investigational Site Number 11
Montreal, H3A 2B4
Investigational Site Number 13
Ottawa, K1H 8L6
Investigational Site Number 18
Québec, G1J 1Z4
Investigational Site Number 14
Toronto, M5B 1W8
Investigational Site Number 17
Vancouver, V6T 2B5
Investigational Site Number 19
Winnipeg, R3E 3N4
France6 sites
Investigational Site Number 24
Clermont-Ferrand, 63003
Investigational Site Number 21
Lyon, 69394
Investigational Site Number 30
Marseille, 13385
Investigational Site Number 23
Montpellier, 34000
Investigational Site Number 28
Nice, 06002
Investigational Site Number 27
Rennes, 35033
About this study
Official title: Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.
Read the detailed description
Subjects completing the HMR 1726D/2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patient lives;
- subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide.
- subjects on placebo are randomized to teriflunomide 7 mg or 14 mg.
The total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives, broken up as follows:
- Treatment: 528 weeks or until teriflunomide is commercially available in the country where patient lives,
- Post-washout follow-up: 4 weeks after last treatment intake.
- Conditions
- Multiple Sclerosis
- Being tested
- teriflunomide (HMR1726)
- Keywords
- Multiple Sclerosis Relapsing Remitting, Secondary Progressive, Progressive Relapsing
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teriflunomide (HMR1726)Drug
tablet, oral administration once daily.
| Study group | Role | What they receive |
|---|---|---|
| Teriflunomide 7 mg | Experimental | Not described Receives: Drug: teriflunomide (HMR1726) |
| Teriflunomide 14 mg | Experimental | Not described Receives: Drug: teriflunomide (HMR1726) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives
Secondary outcomes (6)
Annualized relapse rate (number of relapses per patient-year)
Measured: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Kurtzke Expanded Disability Status Scale (EDSS) score
Measured: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score
Measured: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain Magnetic Resonance Image (MRI)
Measured: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54) score
Measured: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS)
Measured: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul W O'Connor, MD, Principal investigator, St. Michael's Hospital, 30 Bond Street, 3rd floor, Toronto, ON M5B 1W8, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228163
- Sponsor's protocol ID
- LTS6048
- Other IDs
- HMR1726D/2002
- Status last verified
- Mar 2015
- First submitted
- 26 Sep 2005
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.
PubMed 33023488Confavreux C, Li DK, Freedman MS, Truffinet P, Benzerdjeb H, Wang D, Bar-Or A, Traboulsee AL, Reiman LE, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler. 2012 Sep;18(9):1278-89. doi: 10.1177/1352458512436594. Epub 2012 Feb 3.
PubMed 22307384
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
- ClinicalTrials.gov ID
- NCT00228163
- Acronym / sponsor ID
- LTS6048
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis Relapsing Remitting, Secondary Progressive, Progressive Relapsing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Sep 2005 (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 primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.
Detailed description
Subjects completing the HMR 1726D/2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patient lives;
- subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide.
- subjects on placebo are randomized to teriflunomide 7 mg or 14 mg.
The total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives, broken up as follows:
- Treatment: 528 weeks or until teriflunomide is commercially available in the country where patient lives,
- Post-washout follow-up: 4 weeks after last treatment intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriflunomide 7 mg | Experimental | Drug: teriflunomide (HMR1726) |
| Teriflunomide 14 mg | Experimental | Drug: teriflunomide (HMR1726) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Satisfactorily completion of HMR1726D/2001 study with respect to safety.
- If female subject, non-childbearing potential or child bearing potential with adequate contraception.
- Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment.
- Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study.
- Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study.
Key exclusion criteria (10 listed)
- Subject who did not complete HMR 1726D/2001 study for safety reasons.
- Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease.
- Pregnancy.
- Breast-feeding.
- Wish to parent.
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 (HMR1726)tablet, oral administration once daily. | Drug | Teriflunomide 14 mg, Teriflunomide 7 mg |
Primary outcome
Number of patients with adverse events
Time frame: Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives
6 secondary outcomes
Annualized relapse rate (number of relapses per patient-year)
Time frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Kurtzke Expanded Disability Status Scale (EDSS) score
Time frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score
Time frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain Magnetic Resonance Image (MRI)
Time frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54) score
Time frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS)
Time frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives
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 25 Mar 2015.
- Derived from this study: PubMed 33023488Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.
- Derived from this study: PubMed 22307384Confavreux C, Li DK, Freedman MS, Truffinet P, Benzerdjeb H, Wang D, Bar-Or A, Traboulsee AL, Reiman LE, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler. 2012 Sep;18(9):1278-89. doi: 10.1177/1352458512436594. Epub 2012 Feb 3.
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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.
Paul W O'Connor, MD principal investigator
St. Michael's Hospital, 30 Bond Street, 3rd floor, Toronto, ON M5B 1W8, Canada
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing teriflunomide (HMR1726) in people with Multiple Sclerosis, run by Sanofi at 16 sites in 2 countries.
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 7 inclusion and 10 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of patients with adverse events (time frame: Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives). 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 NCT00228163, which also lists 2 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 25 Mar 2015.