A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668
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|ClinicalTrials.gov Identifier: NCT02313285|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2014
Last Update Posted : December 23, 2019
To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who received prior treatment during the TDU13475 or TDU14981 studies.
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.
|Condition or disease|
|Progressive Multiple Sclerosis|
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|
|Actual Enrollment :||54 participants|
|Official Title:||An Open-label, Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668|
|Actual Study Start Date :||January 12, 2015|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Patient who received GZ402668 in prior study (TDU13475 or TDU14981)
Patient who received placebo in prior study (TDU13475 or TDU14981)
- Number of patients with adverse events [ Time Frame: 4 years ]
- 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 ]
- Clinically significant changes in thyroid function tests from baseline [ Time Frame: every 3 months for 4 years ]
- Time to lymphocyte repopulation [ Time Frame: 4 years ]
- Number of patients with anti-drug antibodies [ Time Frame: monthly for first 3 months then at 6 and 12 months for first 1 year ]
- Serum concentrations of GZ402668 [ Time Frame: monthly for first 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313285
|Investigational Site Number 276001|
|Berlin, Germany, 10117|
|Study Director:||Clinical Sciences & Operations||Sanofi|