Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01863888 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | PHASE3 | COMPLETED | 70 | — | — | Oct 1, 2013 | Jan 1, 2015 | Mar 13, 2015 | 10 | Belgium, Germany +1 |
| NCT02046629 | A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers | PHASE1 | COMPLETED | 12 | — | — | May 1, 2014 | Jul 1, 2014 | Aug 21, 2014 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| teriflunomide (HMR1726) | EXPERIMENTAL | Participants administered 14mg Teriflunomide once daily, oral. For participants who permanently discontinue Teriflunomide, an accelerated elimination procedure with either cholestyramine or charcoal will be administered. |
| Reference population | NO_INTERVENTION | Untreated healthy subjects |
| teriflunomide dose 1 | EXPERIMENTAL | Teriflunomide 14mg tablet, oral single dose, fast condition Cholestyramine power, 8 gram,oral three times a day for 4 days, fed condition |
| Name | Type | Description |
|---|---|---|
| teriflunomide HMR1726 | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| cholestyramine | DRUG | Pharmaceutical form:powder Route of administration: oral |
| charcoal | DRUG | Pharmaceutical form:granule Route of administration: oral |
Inclusion criteria: Patients (male and female) with relapsing forms of multiple sclerosis meeting McDonald criteria for MS at the screening visit and having either one of the following treatment status: * Naïve to disease modifying (DM) treatment or no DM treatment for more than 2 years * Or curre...