Phase 2
Completed N=123
Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
Source: ClinicalTrials.gov NCT00475865 ↗Enrolled (actual)
123
Serious AEs
5.7%
Results posted
Nov 2012
Primary outcomePrimary: Overview of Adverse Events (AE] — 32; 35; 35; 3 participants
Summary
The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].
The secondary objectives were:
* to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA 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 GA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overview of Adverse Events (AE] |
32; 35; 35; 3; 3; 1 | — |
| PRIMARY Overview of AE With Potential Risk of Occurrence |
24; 28; 28; 4; 2; 5 | — |
| PRIMARY Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) |
1; 0; 1; 1; 0; 1 | — |
| SECONDARY Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) |
-0.006; -0.030; -0.036 | — |
| SECONDARY Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates) |
0.367; 0.109; 0.171 | — |
| SECONDARY Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan |
0.063; 0.028; 0.017 | — |
| SECONDARY Annualized Relapse Rate [ARR]: Poisson Regression Estimates |
0.475; 0.311; 0.647 | — |
| SECONDARY Pharmacokinetic [PK]: Teriflunomide Plasma Concentration |
23.443; 46.992 | — |
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 Glatiramer Acetate [GA] 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 (NCT00475865). 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.