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OpenTrials
Completed

NCT Number: NCT02313285

A 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.

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Key information

Conditions

Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number 276001

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients with adverse events

    Time frame: 4 years

  2. Safety, as assessed by clinical (physical examination), laboratory (hematology, creatinine, and urinalysis with microscopy), ECG, and vital sign events

    Time frame: monthly for up to 4 years

  3. Clinically significant changes in thyroid function tests from baseline

    Time frame: every 3 months for 4 years

Secondary outcomes

  1. Time to lymphocyte repopulation

    Time frame: 4 years

  2. Number of patients with anti-drug antibodies

    Time frame: monthly for first 3 months then at 6 and 12 months for first 1 year

  3. Serum concentrations of GZ402668

    Time frame: monthly for first 3 months

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2014
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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