Multiple SclerosisPhase 2NCT00811395
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
A Phase 2 study testing Teriflunomide, Interferon-β [IFN-β] and Glatiramer Acetate [GA] in people with Multiple Sclerosis, run by Sanofi at 7 sites in 7 countries.
Trial summary
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with multiple sclerosis [MS] with relapses. 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, Interferon-β [IFN-β] and Glatiramer Acetate [GA]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Oct 2007to Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- PDY6045 or PDY6046 participant who:
- completed the week 24 visit of either study PDY6045 or PDY6046,
- was still meeting eligibility criteria for receiving treatment,
- had agreed to continue stable dose of Interferon-β [IFN-β] or Glatiramer Acetate [GA] and consented to continue on treatment.
Who cannot join
- Any known condition or circumstance that would have prevented in the investigator's opinion, compliance or completion of the study
- The above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with multiple sclerosis [MS] with relapses.
Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging [MRI] parameters.
This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
Read the detailed description
The duration of the extension study per participants was 40 weeks broken down as follows:
- 24-week double-blind treatment period,
- 16-week post-treatment elimination follow-up period.
- Conditions
- Multiple Sclerosis
- Being tested
- Teriflunomide, Placebo (for teriflunomide), Interferon-β [IFN-β], Glatiramer Acetate [GA]
- 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
Also called HMR1726
Film-coated tablet
Oral administration
Placebo (for teriflunomide)Drug
Film-coated tablet
Oral administration
Interferon-β [IFN-β]Drug
Also called Avonex®, Rebif®, Betaseron®
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Glatiramer Acetate [GA]Drug
Also called Copaxone®
Solution in prefilled syringe for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo + IFN-β | Placebo comparator | Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks Receives: Drug: Placebo (for teriflunomide); Drug: Interferon-β [IFN-β] |
| Teriflunomide 7 mg + IFN-β | Experimental | Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks Receives: Drug: Teriflunomide; Drug: Interferon-β [IFN-β] |
| Teriflunomide 14 mg + IFN-β | Experimental | Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks Receives: Drug: Teriflunomide; Drug: Interferon-β [IFN-β] |
| Placebo + GA | Placebo comparator | Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks Receives: Drug: Placebo (for teriflunomide); Drug: Glatiramer Acetate [GA] |
| Teriflunomide 7 mg + GA | Experimental | Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks Receives: Drug: Teriflunomide; Drug: Glatiramer Acetate [GA] |
| Teriflunomide 14 mg + GA | Experimental | Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks Receives: Drug: Teriflunomide; Drug: Glatiramer Acetate [GA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overview of Adverse Events [AE]
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Measured: from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
Overview of AE With Potential Risk of Occurence
AE with potential risk of occurrence were defined as follows:
- Hepatic disorders;
- Immune effects, mainly effects on bone marrow and infection;
- Pancreatic disorders;
- Malignancy;
- Skin disorders, mainly hair loss and hair thinning;
- Pulmonary disorders;
- Hypertension;
- Peripheral neuropathy;
- Psychiatric disorders;
- Hypersensitivity.
Measured: from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]
PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.
Hepatic parameters thresholds were defined as follows:
- Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];
- Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;
- Alkaline Phosphatase >1.5 ULN;
- Total Bilirubin [TB] >1.5 or 2 ULN;
- ALT >3 ULN and TB >2 ULN;
Measured: from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
Secondary outcomes (6)
Annualized Relapse Rate [ARR]: Poisson Regression Estimates
ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.
To account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as "offset" variable and:
- Model 1 (IFN-β groups): treatment group, region of enrollment and IFN-β dose level as covariates
- Model 2 (GA groups): treatment group and region of enrollment as covariates)
Measured: 48 weeks
Overview of 12-week Sustained Disability Progression
12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.
If no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression.
Measured: 48 weeks
Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints
Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.
Measured: 48 weeks
Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.
Least-square means were estimated using two Mixed-effect models with repeated measures [MMRM] on cubic root transformed volume data:
- Model 1 (IFN-β groups): treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors;
- Model 2 (GA groups): treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors.
Measured: baseline (before randomization in PDY6045 or PDY6046) and 48 weeks
Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)
Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.
To account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as "offset" variable and:
- Model 1 (IFN-β groups): Treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates
- Model 2 (GA groups): Treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)
Measured: 48 weeks
Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan
Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 182 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
- NCT00811395
- Sponsor's protocol ID
- LTS6047
- Other IDs
- HMR1726D/2005, 2007-003997-24
- Status last verified
- Dec 2012
- First submitted
- 18 Dec 2008
- Last updated
- 31 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Freedman MS, Wolinsky JS, Wamil B, Confavreux C, Comi G, Kappos L, Olsson TP, Miller A, Benzerdjeb H, Li H, Simonson C, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group and the MRI Analysis Center. Teriflunomide added to interferon-beta in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. doi: 10.1212/WNL.0b013e318258f7d4. Epub 2012 May 23.
PubMed 22622860Freedman MS, Wolinsky JS, Truffinet P, Comi G, Kappos L, Miller AE, Olsson TP, Benamor M, Chambers S, O'Connor PW. A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 10.1177/2055217315618687. eCollection 2015 Jan-Dec.
PubMed 28607708
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses
- ClinicalTrials.gov ID
- NCT00811395
- Acronym / sponsor ID
- LTS6047
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Posted 31 Dec 2012
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 was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with multiple sclerosis [MS] with relapses.
Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging [MRI] parameters.
This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
Detailed description
The duration of the extension study per participants was 40 weeks broken down as follows:
- 24-week double-blind treatment period,
- 16-week post-treatment elimination follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo + IFN-β | Placebo comparator | Drug: Placebo (for teriflunomide), Drug: Interferon-β [IFN-β]Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks |
| Teriflunomide 7 mg + IFN-β | Experimental | Drug: Teriflunomide, Drug: Interferon-β [IFN-β]Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks |
| Teriflunomide 14 mg + IFN-β | Experimental | Drug: Teriflunomide, Drug: Interferon-β [IFN-β]Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks |
| Placebo + GA | Placebo comparator | Drug: Placebo (for teriflunomide), Drug: Glatiramer Acetate [GA]Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks |
| Teriflunomide 7 mg + GA | Experimental | Drug: Teriflunomide, Drug: Glatiramer Acetate [GA]Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks |
| Teriflunomide 14 mg + GA | Experimental | Drug: Teriflunomide, Drug: Glatiramer Acetate [GA]Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PDY6045 or PDY6046 participant who:
Key exclusion criteria (2 listed)
- Any known condition or circumstance that would have prevented in the investigator's opinion, compliance or completion of the study
- The above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial.
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: HMR1726Film-coated tablet Oral administration | Drug | Teriflunomide 14 mg + GA, Teriflunomide 14 mg + IFN-β, Teriflunomide 7 mg + GA, Teriflunomide 7 mg + IFN-β |
| Placebo (for teriflunomide)Film-coated tablet Oral administration | Drug | Placebo + GA, Placebo + IFN-β |
| Interferon-β [IFN-β]Also: Avonex®, Rebif®, Betaseron®Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection | Drug | Placebo + IFN-β, Teriflunomide 14 mg + IFN-β, Teriflunomide 7 mg + IFN-β |
| Glatiramer Acetate [GA]Also: Copaxone®Solution in prefilled syringe for subcutaneous injection | Drug | Placebo + GA, Teriflunomide 14 mg + GA, Teriflunomide 7 mg + GA |
Primary outcome
Overview of Adverse Events [AE]
Time frame: from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Overview of AE With Potential Risk of Occurence
Time frame: from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
AE with potential risk of occurrence were defined as follows: * Hepatic disorders; * Immune effects, mainly effects on bone marrow and infection; * Pancreatic disorders; * Malignancy; * Skin disorders, mainly hair loss and hair thinning; * Pulmonary disorders; * Hypertension; * Peripheral neuropathy; * Psychiatric disorders; * Hypersensitivity.
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]
Time frame: from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)
PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows: * Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN]; * Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN; * Alkaline Phosphatase >1.5 ULN; * Total Bilirubin [TB] >1.5 or 2 ULN; * ALT >3 ULN and TB >2 ULN;
6 secondary outcomes
Annualized Relapse Rate [ARR]: Poisson Regression Estimates
Time frame: 48 weeks
Overview of 12-week Sustained Disability Progression
Time frame: 48 weeks
Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints
Time frame: 48 weeks
Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
Time frame: baseline (before randomization in PDY6045 or PDY6046) and 48 weeks
Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)
Time frame: 48 weeks
Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22622860Freedman MS, Wolinsky JS, Wamil B, Confavreux C, Comi G, Kappos L, Olsson TP, Miller A, Benzerdjeb H, Li H, Simonson C, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group and the MRI Analysis Center. Teriflunomide added to interferon-beta in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. doi: 10.1212/WNL.0b013e318258f7d4. Epub 2012 May 23.
- Derived from this study: PubMed 28607708Freedman MS, Wolinsky JS, Truffinet P, Comi G, Kappos L, Miller AE, Olsson TP, Benamor M, Chambers S, O'Connor PW. A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 10.1177/2055217315618687. eCollection 2015 Jan-Dec.
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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
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teriflunomide, Interferon-β [IFN-β] and Glatiramer Acetate [GA] in people with Multiple Sclerosis, run by Sanofi at 7 sites in 7 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 4 inclusion and 2 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 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Austria, Canada, Germany, Italy and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 31 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overview of Adverse Events [AE] (time frame: from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)). The study lists 3 primary outcomes in all. 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 NCT00811395, 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 31 Dec 2012.