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NCT00489489 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis

A Phase 2 study, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
118
Enrollment target

NCT00489489: Completed Phase 2 study, sponsored by Sanofi.

NCT00489489 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00489489, a Phase 2 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
118 participants
Enrollment target

Study 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.

Primary Outcome

AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

Interventions

  • DRUG Teriflunomide
  • DRUG Placebo (for Teriflunomide)
  • DRUG Interferon-β

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2007-05
Est. Completion 2009-06
Phase Phase 2
Sanofi

713 total trials

What the finished NCT00489489 record still lists

NCT00489489 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).

The record links to 0 conditions, and to 3 interventions - of which Teriflunomide is the first listed.

NCT00489489 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00489489 about?

NCT00489489 is a clinical study titled "Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis". 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 e...

What is the current status of trial NCT00489489?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2007-05. Estimated completion is 2009-06.

What interventions are being tested in trial NCT00489489?

The interventions under investigation include: Teriflunomide (DRUG), Placebo (for Teriflunomide) (DRUG), Interferon-β (DRUG).

Who is sponsoring clinical trial NCT00489489?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00489489's enrollment target sits among peer trials

118 618th of 2000 higher than 1,378 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00489489, the US trial registry maintained by the National Library of Medicine. NCT00489489 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.