Phase 2
Completed N=118
Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis
Source: ClinicalTrials.gov NCT00489489 ↗Enrolled (actual)
118
Serious AEs
2.6%
Results posted
Nov 2012
Primary outcomePrimary: Overview of Adverse Events [AE] — 35; 33; 32; 1 participants
Summary
The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of interferon-β [IFN-β].
Secondary objectives were:
* to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue;
* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overview of Adverse Events [AE] |
35; 33; 32; 1; 2; 0 | — |
| PRIMARY Overview of AE With Potential Risk of Occurrence |
24; 25; 26; 5; 8; 11 | — |
| PRIMARY Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) |
2; 0; 2; 1; 0; 1 | — |
| SECONDARY Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) |
-0.001; 0.002; -0.028 | — |
| SECONDARY Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates) |
0.570; 0.099; 0.089 | — |
| SECONDARY Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan |
0.068; 0.022; 0.024 | — |
| SECONDARY Annualized Relapse Rate [ARR]: Poisson Regression Estimates |
0.260; 0.280; 0.109 | — |
| SECONDARY Pharmacokinetic [PK]: Teriflunomide Plasma Concentration |
21.437; 47.761 | — |
Eligibility Criteria
Inclusion Criteria
- Definite MS diagnosis according to McDonald's criteria;
- Relapsing clinical course, with or without progression;
- Expanded Disability Status Scale [EDSS] less or equal to 5.5 (ambulatory);
- Stable dose of IFN-β for at least 26 weeks prior to the screening visit;
- No onset of MS relapse in the preceding 60 days prior to randomization;
- Clinically stable for 4 weeks prior to randomization.
Exclusion Criteria
- Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
- Pregnant or nursing woman;
- Alcohol or drug abuse;
- Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
- Human immunodeficiency virus [HIV] positive status;
- 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.
Data sourced from ClinicalTrials.gov (NCT00489489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.