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

Completed

• Conditions: Progressive Multiple Sclerosis

• Registration Number: NCT02313285
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-10
• Study Start: 2015-01-12
• Status Verified: 2022-04
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-20
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically significant changes in thyroid function tests from baseline	every 3 months for 4 years
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Investigational Site Number 276001; 🇩🇪 Berlin, Germany