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Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02201108
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE July 25, 2014
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE July 16, 2014
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
Time to first clinical relapse after randomization [ Time Frame: over 96 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • Proportion of relapse free participants [ Time Frame: at 24, 48, 72 and 96 weeks ]
  • Number of of new/newly enlarged T2 lesions [ Time Frame: over 96 weeks ]
  • Number of T1 Gd-enhancing T1 lesions [ Time Frame: over 96 weeks ]
  • Change in volume of T2 lesions [ Time Frame: over 96 weeks ]
  • Change in volume of T1 hypointense lesions [ Time Frame: over 96 weeks ]
  • Number of new T1 hypointense lesions [ Time Frame: over 96 weeks ]
  • Proportion of participants free of new or enlarged MRI T2-lesions [ Time Frame: at 48 weeks and 96 weeks ]
  • Brain atrophy [ Time Frame: over 96 weeks ]
  • Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test [ Time Frame: at randomization, then every 24 weeks (SDMT only) and at 96 weeks ]
  • Safety, as assessed by clinical, laboratory, ECG, and vital signs events [ Time Frame: over 96 weeks ]
  • Assessment of teriflunomide pharmacokinetics (PK) parameter: (Ctrough) lowest concentration of drug in the blood measured after dosing [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
  • Assessment of teriflunomide PK parameter: (Cmax) maximum plasma drug concentration [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
  • Assessment of teriflunomide PK parameter: (AUC0-24) area under the plasma concentration-time curve from time zero to 24 hours [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • Proportion of relapse free patients [ Time Frame: at 24, 48, 72 and 96 weeks ]
  • Number of of new/newly enlarged T2 lesions [ Time Frame: at 24, 48, 72 and 96 weeks ]
  • Number of T1 Gd-enhancing T1 lesions [ Time Frame: over 96 weeks ]
  • Change in volume of T2 lesions [ Time Frame: over 96 weeks ]
  • Change in volume of T1 hypointense lesions [ Time Frame: over 96 weeks ]
  • Number of new T1 hypointense lesions [ Time Frame: over 96 weeks ]
  • Proportion of patients free of new or enlarged MRI T2-lesions [ Time Frame: at 48 weeks and 96 weeks ]
  • Brain atrophy [ Time Frame: over 96 weeks ]
  • Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test [ Time Frame: at randomization, then every 24 weeks (SDMT only) and at 96 weeks ]
  • Safety, as assessed by clinical, laboratory, ECG, and vital signs events [ Time Frame: over 96 weeks ]
  • Assessment of PK parameter - lowest concentration of drug in the blood measured after dosing (Ctrough) [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Official Title  ICMJE A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension
Brief Summary

Primary Objective:

To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.

Secondary Objective:

  • To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function.
  • To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
  • To evaluate the pharmacokinetics (PK) of teriflunomide.
Detailed Description

The study duration includes a screening period up to 4 weeks, a double-blind treatment period of up to 96 weeks, an open-label period including the remainder of the initial 96 weeks, where applicable, and a 96-week extension, i.e., up to a maximum of 192 weeks after randomization. There will be a follow-up period of 4 weeks for participants discontinuing treatment.

Within the 96 weeks double-blind treatment period, the first 4 weeks are pharmacokinetic (PK) run-in phase in which PK samples (blood samples) will be collected from participants and then 4 weeks of analysis (no samples drawn). The PK run-in phase (total 8 weeks) is intended to provide individual PK parameters to allow the dose adjustment to the 14 mg adult-equivalent dose for the rest of the study.

Participants experiencing a relapse after the PK run-in phase (8 weeks) and if confirmed by the Relapse Adjudication Panel (RAP) and patients fulfilling MRI criteria (high number of new lesions at week 36, 48 or 72 compared to previous images) will have the option to continue in an open label teriflunomide treatment arm up to 192 weeks from randomization.

An optional additional extension period is available for young participants with teriflunomide until the participants are 18 years old and/or able to switch to commercial product, whichever comes first.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: Teriflunomide
    Pharmaceutical form:film-coated tablet Route of administration: oral
    Other Name: AUBAGIO, HMR1726
  • Drug: Placebo
    Pharmaceutical form:tablet Route of administration: oral
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching placebo tablets
    Intervention: Drug: Placebo
  • Experimental: Teriflunomide
    Teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent
    Intervention: Drug: Teriflunomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2014)
165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 29, 2021
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Patients with relapsing multiple sclerosis are eligible. Patients should meet the criteria of multiple sclerosis (MS) based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 (5) and have:
  • at least one relapse (or attack) in the 12 months preceding screening or
  • at least two relapses (or attack) in the 24 months preceding screening.
  • <18 years of age and ≥10 years of age at randomization. Specific for the Russian Federation from 18 December 2014 to 26 July 2016, ≤17 years of age and ≥13 years of age at randomization
  • Signed informed consent/assent obtained from patient and patient's legal representative (parents or guardians) according to local regulations.

Exclusion criteria:

  • Expanded disability status scale (EDSS) score > 5.5 at screening or randomization visits.
  • Relapse within 30 days prior to randomization.
  • Treated with:

glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization fingolimod, or intravenous immunoglobulins within 3 months prior to randomization natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization, cladribine or mitoxantrone within 2 years prior to randomization

  • Treated with alemtuzumab at any time.
  • History of HIV infection.
  • Contraindication for magnetic resonance imaging (MRI).
  • Pregnant or breast-feeding females or those who plan to become pregnant during the study.
  • Female patients of child-bearing potential not using highly effective contraceptive method (contraception in both female and male is required).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   China,   Estonia,   France,   Greece,   Israel,   Lebanon,   Lithuania,   Morocco,   Netherlands,   North Macedonia,   Portugal,   Russian Federation,   Serbia,   Slovenia,   Spain,   Tunisia,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Australia,   Macedonia, The Former Yugoslav Republic of,   Poland
 
Administrative Information
NCT Number  ICMJE NCT02201108
Other Study ID Numbers  ICMJE EFC11759
2011-005249-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP