Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

NCT01487096 | Completed Phase 2 DMC

• 1 other identifier: HMR1726D/2001
• Study Type: interventional
• Target: 179
• Locations: 2 countries
• Sites: 2

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis)

  The number of unique active lesions per scan was calculated by dividing the sum of unique newly active lesions and unique persistently active lesions observed on treatment by the number of scans performed on treatment. Unique newly active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan but not in the previous scan and, that had not been classified as unique newly active in any previous scan. Unique persistently active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan and also in the previous scan.

  36 weeks

• 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.

  from first study drug intake up to 6 weeks after last intake or entry in the extension study, whichever came first

Secondary Outcomes (6)

• MRI assessment: number of T1-enhancing lesions per scan

  36 weeks

• MRI assessment: number of T2-lesions per scan

  36 weeks

• MRI assessment: Number of participants with no new lesions

  36 weeks

• MRI assessment: Change from baseline in T2 burden of disease

  36 weeks

• Number of participants with progression on Expanded Disability Status Scale [EDSS]

  36 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo (for teriflunomide), * two tablets once daily for 1 week then, * one tablet once daily for 35 weeks.

Drug: Placebo (placebo for teriflunomide)

Teriflunomide 7 mg

EXPERIMENTAL

Teriflunomide 7 mg: * two tablets once daily for 1 week then, * one tablet once daily for 35 weeks.

Drug: Teriflunomide

Teriflunomide 14 mg

EXPERIMENTAL

Teriflunomide 14 mg: * two tablets once daily for 1 week then, * one tablet once daily for 35 weeks.

Drug: Teriflunomide

Interventions

Teriflunomide DRUG

film-coated tablet oral administration

Also known as: HMR1726

Teriflunomide 14 mg; Teriflunomide 7 mg

Placebo (placebo for teriflunomide) DRUG

film-coated tablet oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Canada

Toronto, Ontario, Canada

Location

sanofi-aventis France

Lyon, France

Location

Related Publications (2)

• 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.

  PMID: 16567708 RESULT

• 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.

  PMID: 33023488 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

teriflunomide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Study Director

  Clinical Science & Operation - sanofi-aventis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: April 1, 2001
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

CA (1); FR (1)