A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668

An Open-label, Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668

Primary Objective:

To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who received prior treatment during the TDU13475 or TDU14981 studies.

Secondary Objectives:

To assess the pharmacokinetics of GZ402668 in patients with MS. To assess the pharmacodynamics of GZ402668 in patients with MS. To assess the immunogenicity of GZ402668 in patients with MS.

Study Overview

• Status: Completed
• Conditions: Progressive Multiple Sclerosis

Detailed Description

The total study duration for a patient is approximately 47 months.

There is no administration of GZ402668 in the LTS14120 study. Patients who already received investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981 will be followed up to 47 months in the LTS14120.

Note: Patients from TDU14981 study (sanofi-sponsored) will participate in LTS14120 study. In order to keep consistent among all study related documents, the title of the LTS14120 study is not amended.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Investigational Site Number 276001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who received study drug in the clinical study TDU13475

Description

Inclusion criteria:

Received investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
GZ402668; Patient who received GZ402668 in prior study (TDU13475 or TDU14981)
Placebo; Patient who received placebo in prior study (TDU13475 or TDU14981)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	4 years
Safety, as assessed by clinical (physical examination), laboratory (hematology, creatinine, and urinalysis with microscopy), ECG, and vital sign events	monthly for up to 4 years
Clinically significant changes in thyroid function tests from baseline	every 3 months for 4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to lymphocyte repopulation	4 years
Number of patients with anti-drug antibodies	monthly for first 3 months then at 6 and 12 months for first 1 year
Serum concentrations of GZ402668	monthly for first 3 months

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2015
• Primary Completion (ACTUAL): April 20, 2022
• Study Completion (ACTUAL): April 20, 2022

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (ESTIMATE): December 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
• Other Study ID Numbers: LTS14120; 2014-001592-31 (EUDRACT_NUMBER); U1111-1158-9815 (OTHER: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No