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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02313285

Enrollment

Registered

2014-12-10

Start date

2015-01-12

Completion date

2022-04-20

Last updated

2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive Multiple Sclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 66 Years

Healthy volunteers

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.

Design outcomes

Primary

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

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

Countries

Germany

Outcome results