Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (TEMSO)
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
The primary objective of this study was to determine the effects of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis.
The secondary objectives were to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale (EDSS); the burden of disease as measured by magnetic resonance imaging (MRI); subject-reported fatigue; and to evaluate the safety and tolerability of teriflunomide.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: Teriflunomide (HMR1726) Drug: placebo |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses |
- Annualized relapse rate (number of relapses per subject/year) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Time to disability progression as assessed by Kurtzke Expended Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Proportion of subjects free of disability progression [ Time Frame: 6 months, 1 year and 2 years ] [ Designated as safety issue: No ]
- Burden of disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]Change from baseline in the volume of abnormal brain tissue as assessed by cerebral Magnetic Resonance Imaging (MRI)
- Subject-reported fatigue as assessed by the Fatigue Impact Scale (FIS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Enrollment: | 1088 |
Study Start Date: | September 2004 |
Study Completion Date: | July 2010 |
Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Teriflunomide 7 mg |
Drug: Teriflunomide (HMR1726)
Tablet, oral administration once daily
|
Experimental: Teriflunomide 14 mg |
Drug: Teriflunomide (HMR1726)
Tablet, oral administration once daily
|
Placebo Comparator: Placebo |
Drug: placebo
Matching tablet, oral administration once daily
|
Detailed Description:
The study period per patient was approximatively 128 weeks broken down as follows:
- Screening period up to 4 weeks,
- Double-blind treatment period of 108 weeks (approximatively 2 years),
- Post-treatment wash-out follow-up period of 16 weeks (if not entering in the extension study LTS6050).
The patients successfully competing the study treatment were offered the opportunity to enter an optional long-term extension study LTS6050.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Multiple sclerosis (MS) subjects,who were ambulatory (EDSS of ≤ 5.5),
- Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing),
- Meeting McDonald's criteria for MS diagnosis,
- Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial.
- No relapse onset in the preceding 60 days prior to randomization.
- During the 30 days prior to randomization, subjects should have been clinically stable, without adrenocorticotrophic hormone (ACTH) or systemic steroid treatment.
- Signed informed consent form.
Exclusion Criteria:
- Patients with clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
- Patients with significantly impaired bone marrow function;
- Pregnant or nursing women.
- Alcohol or drug abuse.
- 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 have prevented in the investigator's opinion compliance or completion of the study.
Show 21 Study Locations
Principal Investigator: | Paul O'Connor, MD | St. Michael's Hospital Toronto (Canada) |
No publications provided by Sanofi-Aventis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Trial Transparency Team, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00134563 History of Changes |
Other Study ID Numbers: | EFC6049, 2004-000555-42, HMR1726D/3001 |
Study First Received: | August 23, 2005 |
Last Updated: | August 8, 2011 |
Health Authority: | Canada: Health Canada France: Ministry of Health Russia: Pharmacological Committee, Ministry of Health |
Keywords provided by Sanofi-Aventis:
Multiple Sclerosis Relapsing Remitting Secondary Progressive Progressive Relapsing |
Additional relevant MeSH terms:
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on October 16, 2012