Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis

Sanofi

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo (for teriflunomide); Drug: Glatiramer Acetate [GA]; Drug: Interferon-β [IFN-β]; Drug: Teriflunomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811395

HMR1726D/2005 (Other Identifier)

LTS6047

2007-003997-24 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The duration of the extension study per participants was 40 weeks broken down as follows:

• 24-week double-blind treatment period,
• 16-week post-treatment elimination follow-up period.

Enrollment: 182 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

182 participants in 6 patient groups, including a placebo group

Placebo + IFN-β

Placebo Comparator group

Description:

Placebo (for teriflunomide) once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks

Treatment:

Drug: Placebo (for teriflunomide)

Drug: Interferon-β [IFN-β]

Teriflunomide 7 mg + IFN-β

Experimental group

Description:

Teriflunomide 7 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks

Treatment:

Drug: Teriflunomide

Drug: Interferon-β [IFN-β]

Teriflunomide 14 mg + IFN-β

Experimental group

Description:

Teriflunomide 14 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks

Treatment:

Drug: Teriflunomide

Drug: Interferon-β [IFN-β]

Placebo + GA

Placebo Comparator group

Description:

Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks

Treatment:

Drug: Placebo (for teriflunomide)

Drug: Glatiramer Acetate [GA]

Teriflunomide 7 mg + GA

Experimental group

Description:

Teriflunomide 7 mg once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks

Treatment:

Drug: Teriflunomide

Drug: Glatiramer Acetate [GA]

Teriflunomide 14 mg + GA

Experimental group

Description:

Teriflunomide 14 mg once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks

Treatment:

Drug: Teriflunomide

Drug: Glatiramer Acetate [GA]