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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1205-3009 | Other Identifier | UTN |
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Primary Objective:
To describe the safety of teriflunomide in patients with relapsing forms of multiple sclerosis.
Secondary Objective:
To describe the efficacy of teriflunomide in patients with relapsing forms of multiple sclerosis.
The study duration is one year; post treatment safety follow up visit will be conducted 4 weeks after the patient takes the last dose of teriflunomide
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aubagio®/Teriflunomide | Experimental | Single dose of Aubagio® to be taken orally, once daily in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TERIFLUNOMIDE HMR1726 | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence of adverse events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized relapse rate | Number of relapses per patient-year | 1 year |
| First relapse | Time to first relapse | 1 year |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :024 | Ahmedabad | 380054 | India | |||
| Investigational Site Number :017 |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
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| ID | Term |
|---|---|
| C527525 | teriflunomide |
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| Relapse free | Proportion of patients who are relapse free | 1 year |
| Neurological impairment/disability | Expanded Disability Status Scale (EDSS) will be used to compare disability from baseline. The EDSS ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | Baseline to 3 months, 6 months, 9 months and 1 year |
| Disability progression | Proportion of patients free of disability progression | 1 year |
| Drug compliance | Percentage of patients who are treatment compliant assessed using patient diary | 1 year |
| Bengaluru |
| 560054 |
| India |
| Investigational Site Number :001 | Chandigarh | 160012 | India |
| Investigational Site Number :023 | Coimbatore | India |
| Investigational Site Number :007 | Gurgaon | 122001 | India |
| Investigational Site Number :026 | Gurgaon | India |
| Investigational Site Number :005 | Kochi | 682041 | India |
| Investigational Site Number :006 | Kolkata | 700068 | India |
| Investigational Site Number :011 | Lucknow | 226003 | India |
| Investigational Site Number :020 | Ludhiana | 141001 | India |
| Investigational Site Number :018 | Nashik | 422001 | India |
| Investigational Site Number :025 | New Delhi | India |
| Investigational Site Number :014 | Pune | 411004 | India |
| Investigational Site Number :022 | Thiruvananthapuram | 695011 | India |