Clinical trial NCT01487096: Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Official title: A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.

Secondary objectives were:

* To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.
* To investigate the pharmacokinetic and pharmacodynamic relationships.

Detailed description: The total duration of the study period per participants was 46 weeks comprising 3 periods:

* a 4-week screening period,
* a 36-week double-blind treatment period,
* a 6-week post-treatment follow-up period.

Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.

Eligibility criteria: Inclusion Criteria:

* Clinically confirmed multiple sclerosis \[MS\];
* Expanded Disability Status Scale \[EDSS\] score less or equal to 6;
* Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
* Screening magnetic resonance imaging \[MRI\] scan fulfilling the criteria for a diagnosis of MS.

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
* Pregnant or nursing woman;
* Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
* Prior treatment with interferon \[IFN\], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis)
timeFrame: 36 weeks
measure: Overview of Adverse Events [AE]
timeFrame: from first study drug intake up to 6 weeks after last intake or entry in the extension study, whichever came first
Secondary outcomes:
measure: MRI assessment: number of T1-enhancing lesions per scan
timeFrame: 36 weeks
measure: MRI assessment: number of T2-lesions per scan
timeFrame: 36 weeks
measure: MRI assessment: Number of participants with no new lesions
timeFrame: 36 weeks
measure: MRI assessment: Change from baseline in T2 burden of disease
timeFrame: 36 weeks
measure: Number of participants with progression on Expanded Disability Status Scale [EDSS]
timeFrame: 36 weeks
measure: Number of participants with MS relapse confirmed by Scripps Neurological Rating Scale [NRS] and EDSS scores.
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canada
state: Ontario
city: Lyon
country: France
facility: sanofi-aventis France
Study officials:
affiliation: Clinical Science & Operation - sanofi-aventis
name: Clinical Study Director
role: STUDY_DIRECTOR
References:
citation: O'Connor PW, Li D, Freedman MS, Bar-Or A, Rice GP, Confavreux C, Paty DW, Stewart JA, Scheyer R; Teriflunomide Multiple Sclerosis Trial Group; University of British Columbia MS/MRI Research Group. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900. doi: 10.1212/01.wnl.0000203121.04509.31.
citation: 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.