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Trial record 1 of 2 for:    TDU13475
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A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02313285
Recruitment Status : Active, not recruiting
First Posted : December 10, 2014
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date December 4, 2014
First Posted Date December 10, 2014
Last Update Posted Date December 23, 2019
Actual Study Start Date January 12, 2015
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2014)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 9, 2014)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668
Official Title An Open-label, Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who received study drug in the clinical study TDU13475
Condition Progressive Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • GZ402668
    Patient who received GZ402668 in prior study (TDU13475 or TDU14981)
  • Placebo
    Patient who received placebo in prior study (TDU13475 or TDU14981)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 20, 2019)
54
Original Estimated Enrollment
 (submitted: December 9, 2014)
48
Estimated Study Completion Date April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02313285
Other Study ID Numbers LTS14120
2014-001592-31 ( EudraCT Number )
U1111-1158-9815 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor Genzyme, a Sanofi Company
Collaborators Not Provided
Investigators
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date December 2019