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

Genzyme

Status: Completed

Conditions: Progressive Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02313285

U1111-1158-9815 (Other Identifier)

LTS14120

2014-001592-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

64 participants in 2 patient groups

GZ402668

Description:

Patient who received GZ402668 in prior study (TDU13475 or TDU14981)

Placebo

Description:

Patient who received placebo in prior study (TDU13475 or TDU14981)