NCT00475865|CompletedPhase 2ResultsDMC

Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis

Sanofi ClinicalTrials.gov

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3 other identifiers

PDY60462006-004893-29HMR1726D-2004

Study Type

interventional

Target

123

Locations

6 countries

Sites

Timeline

RegisteredMay 2007

StartedApr 2007

CompletionOct 2009

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

123

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline

Completed

Started Apr 2007

Geographic Reach

6 countries

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

April 1, 2007

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

November 2, 2012

Completed

Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

2.5 years

First QC Date

May 18, 2007

Results QC Date

October 3, 2012

Last Update Submit

November 5, 2012

Conditions

Multiple Sclerosis

Keywords

MSglatiramer acetateadjunctive therapyrelapses

Outcome Measures

Primary Outcomes (3)

Overview of Adverse Events (AE]
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
Overview of AE With Potential Risk of Occurrence
AE with potential risk of occurrence were defined as follows: * Hepatic disorders; * Immune effects, mainly effects on bone marrow and infection; * Pancreatic disorders; * Malignancy; * Skin disorders, mainly hair loss and hair thinning; * Pulmonary disorders; * Hypertension; * Peripheral neuropathy; * Psychiatric disorders; * Hypersensitivity.
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows: * Alanine Aminotransferase \[ALT\] \>3, 5, 10 or 20 Upper Normal Limit \[ULN\]; * Aspartate aminotransferase \[AST\] \>3, 5, 10 or 20 ULN; * Alkaline Phosphatase \>1.5 ULN; * Total Bilirubin \[TB\] \>1.5 or 2 ULN; * ALT \>3 ULN and TB \>2 ULN.
from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)

Secondary Outcomes (5)

Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
baseline (before randomization) and 24 weeks
Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)
24 weeks
Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan
24 weeks
Annualized Relapse Rate [ARR]: Poisson Regression Estimates
24 weeks
Pharmacokinetic [PK]: Teriflunomide Plasma Concentration
24 weeks

Study Arms (3)

Placebo + GA

PLACEBO COMPARATOR

Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate (GA) for 24 weeks

Drug: Placebo (for teriflunomide)Drug: Glatiramer Acetate (GA)

Teriflunomide 7 mg + GA

EXPERIMENTAL

Teriflunomide 7 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks

Drug: TeriflunomideDrug: Glatiramer Acetate (GA)

Teriflunomide 14 mg + GA

EXPERIMENTAL

Teriflunomide 14 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks

Drug: TeriflunomideDrug: Glatiramer Acetate (GA)

Interventions

TeriflunomideDRUG

Film-coated tablet Oral administration

Also known as: HMR1726

Teriflunomide 14 mg + GATeriflunomide 7 mg + GA

Placebo (for teriflunomide)DRUG

Film-coated tablet Oral administration

Placebo + GA

Glatiramer Acetate (GA)DRUG

Solution in prefilled syringe for subcutaneous injection

Also known as: Copaxone®

Placebo + GATeriflunomide 14 mg + GATeriflunomide 7 mg + GA

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.