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History of Changes for Study: NCT02201108
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)
Latest version (submitted June 15, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 24, 2014 None (earliest Version on record)
2 July 29, 2014 Recruitment Status, Contacts/Locations and Study Status
3 September 9, 2014 Study Status and Contacts/Locations
4 September 22, 2014 Contacts/Locations and Study Status
5 October 13, 2014 Contacts/Locations and Study Status
6 October 27, 2014 Contacts/Locations and Study Status
7 November 13, 2014 Contacts/Locations and Study Status
8 November 26, 2014 Contacts/Locations and Study Status
9 December 8, 2014 Study Status and Contacts/Locations
10 December 22, 2014 Contacts/Locations and Study Status
11 January 8, 2015 Contacts/Locations and Study Status
12 February 4, 2015 Study Status and Contacts/Locations
13 February 17, 2015 Contacts/Locations and Study Status
14 March 5, 2015 Contacts/Locations and Study Status
15 April 8, 2015 Study Status and Contacts/Locations
16 April 22, 2015 Contacts/Locations and Study Status
17 May 22, 2015 Study Status
18 September 24, 2015 Contacts/Locations and Study Status
19 November 4, 2015 Study Status and Contacts/Locations
20 December 2, 2015 Study Status and Contacts/Locations
21 December 11, 2015 Study Status
22 December 16, 2015 Contacts/Locations and Study Status
23 January 6, 2016 Study Status and Contacts/Locations
24 January 20, 2016 Contacts/Locations and Study Status
25 April 11, 2016 Study Status and Contacts/Locations
26 June 14, 2016 Study Status and Contacts/Locations
27 June 28, 2016 Contacts/Locations and Study Status
28 July 12, 2016 Study Status and Contacts/Locations
29 August 2, 2016 Study Status
30 August 16, 2016 Contacts/Locations and Study Status
31 August 30, 2016 Contacts/Locations and Study Status
32 September 15, 2016 Study Status and Contacts/Locations
33 September 27, 2016 Contacts/Locations and Study Status
34 November 15, 2016 Study Status and Contacts/Locations
35 November 23, 2016 Contacts/Locations and Study Status
36 November 29, 2016 Study Status
37 December 8, 2016 Study Status and Contacts/Locations
38 December 21, 2016 Contacts/Locations and Study Status
39 January 11, 2017 Study Status and Contacts/Locations
40 January 25, 2017 Contacts/Locations and Study Status
41 February 9, 2017 Study Status
42 March 1, 2017 Contacts/Locations and Study Status
43 March 9, 2017 Study Status
44 April 6, 2017 Study Status
45 May 10, 2017 Study Status and Contacts/Locations
46 June 9, 2017 Study Status
47 June 26, 2017 Contacts/Locations and Study Status
48 July 10, 2017 Contacts/Locations and Study Status
49 August 2, 2017 Study Status and Contacts/Locations
50 August 17, 2017 Contacts/Locations and Study Status
51 August 30, 2017 Contacts/Locations and Study Status
52 September 7, 2017 Study Status
53 September 13, 2017 Study Status
54 September 28, 2017 Contacts/Locations and Study Status
55 October 10, 2017 Study Status and Contacts/Locations
56 October 25, 2017 Contacts/Locations and Study Status
57 November 8, 2017 Contacts/Locations and Study Status
58 December 21, 2017 Contacts/Locations and Study Status
59 January 10, 2018 Study Status and Contacts/Locations
60 January 29, 2018 Contacts/Locations and Study Status
61 February 2, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
62 February 22, 2018 Study Status and Contacts/Locations
63 March 8, 2018 Study Status
64 August 20, 2018 Contacts/Locations and Study Status
65 October 26, 2018 Arms and Interventions, Study Design, Study Status, Eligibility, Outcome Measures, Study Identification and Study Description
66 March 19, 2019 Study Status
67 April 9, 2019 Study Status
68 September 24, 2019 Study Status and Contacts/Locations
69 November 27, 2019 Study Status
70 February 6, 2020 Study Status
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Results Submission Events
71 November 27, 2020 Outcome Measures, Study Status, Eligibility, Study Design, Study Description, Document Section, Results, IPDSharing, Arms and Interventions and Study Identification
72 October 14, 2021 Recruitment Status, Contacts/Locations and Study Status
73 June 15, 2022 Recruitment Status, Outcome Measures, Adverse Events, Participant Flow, Study Status, Document Section, Baseline Characteristics, More Information and IPDSharing
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Study NCT02201108
Submitted Date:  July 24, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: EFC11759
Brief Title: Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)
Official Title: 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
Secondary IDs: PIP - 2011-005249-12
U1111-1124-0983 [UTN]
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Not yet recruiting
Study Start: July 2014
Primary Completion: January 2020 [Anticipated]
Study Completion: January 2020 [Anticipated]
First Submitted: July 17, 2014
First Submitted that
Met QC Criteria:
July 24, 2014
First Posted: July 25, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 24, 2014
Last Update Posted: July 25, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Genzyme, a Sanofi Company
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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 Objectives:

  • To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain 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:
  • A screening period up to 4 weeks
  • A double-blind treatment period of up to 96 weeks for each patient
  • An open-label period including the remainder of the initial 96 weeks, where applicable, and a 96-week extension, ie, up to a maximum of 192 weeks after randomization
  • A follow-up period of 4 weeks for patients 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 patients 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 14mg adult-equivalent dose for the rest of the study.

Patients 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 randomisation.

Open or close this module Conditions
Conditions: Multiple Sclerosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 165 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: placebo
Matching placebo tablets
Drug: Placebo
Pharmaceutical form:tablet Route of administration: oral
Experimental: Teriflunomide
teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent
Drug: Teriflunomide HMR1726
Pharmaceutical form:film-coated tablet Route of administration: oral
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Time to first clinical relapse after randomization
[ Time Frame: over 96 weeks ]

Secondary Outcome Measures:
1. Proportion of relapse free patients
[ Time Frame: at 24, 48, 72 and 96 weeks ]

2. Number of of new/newly enlarged T2 lesions
[ Time Frame: at 24, 48, 72 and 96 weeks ]

3. Number of T1 Gd-enhancing T1 lesions
[ Time Frame: over 96 weeks ]

4. Change in volume of T2 lesions
[ Time Frame: over 96 weeks ]

5. Change in volume of T1 hypointense lesions
[ Time Frame: over 96 weeks ]

6. Number of new T1 hypointense lesions
[ Time Frame: over 96 weeks ]

7. Proportion of patients free of new or enlarged MRI T2-lesions
[ Time Frame: at 48 weeks and 96 weeks ]

8. Brain atrophy
[ Time Frame: over 96 weeks ]

9. 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 ]

10. Safety, as assessed by clinical, laboratory, ECG, and vital signs events
[ Time Frame: over 96 weeks ]

11. 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 ]

Open or close this module Eligibility
Minimum Age: 10 Years
Maximum Age: 17 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion criteria:

  • Patients with relapsing multiple sclerosis are eligible. Patients should meet the criteria of 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 randomization or
    • at least two relapses (or attack) in the 24 months preceding randomization.
  • ≤17 years of age and ≥10 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:

  • 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 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.

Open or close this module Contacts/Locations
Central Contact Person: Trial Transparency Team
Email: Contact-US@sanofi.com
Study Officials: Clinical Sciences & Operations
Study Director
Sanofi
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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