Phase 2
Completed N=239
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
Source: ClinicalTrials.gov NCT00811395 ↗Enrolled (actual)
239
Serious AEs
8.4%
Results posted
Dec 2012
Primary outcomePrimary: Overview of Adverse Events [AE] — 35; 35; 33; 39 participants
Summary
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with multiple sclerosis [MS] with relapses.
Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging [MRI] parameters.
This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overview of Adverse Events [AE] |
35; 35; 33; 39; 40; 38 | — |
| PRIMARY Overview of AE With Potential Risk of Occurence |
28; 30; 30; 34; 33; 32 | — |
| PRIMARY Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] |
2; 1; 3; 1; 0; 1 | — |
| SECONDARY Annualized Relapse Rate [ARR]: Poisson Regression Estimates |
0.343; 0.231; 0.144; 0.420; 0.262; 0.497 | — |
| SECONDARY Overview of 12-week Sustained Disability Progression |
0; 3; 2; 4; 1; 4 | — |
| SECONDARY Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints |
0.0; 3.0; 2.7; 2.5; 0.0; 5.6 | — |
| SECONDARY Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) |
-0.017; -0.011; -0.012; 0.016; -0.010; -0.063 | — |
| SECONDARY Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates) |
0.521; 0.080; 0.090; 0.333; 0.120; 0.178 | — |
| SECONDARY Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan |
0.068; 0.019; 0.020; 0.052; 0.031; 0.014 | — |
Eligibility Criteria
Inclusion Criteria
- PDY6045 or PDY6046 participant who:
- completed the week 24 visit of either study PDY6045 or PDY6046,
- was still meeting eligibility criteria for receiving treatment,
- had agreed to continue stable dose of Interferon-β [IFN-β] or Glatiramer Acetate [GA] and consented to continue on treatment.
Exclusion Criteria
- Any known condition or circumstance that would have prevented in the investigator's opinion, compliance or completion of the study
The above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT00811395). 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.