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

NCT02313285 | Completed

• 3 other identifiers: LTS141202014-001592-31U1111-1158-9815
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

GZ402668

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

Placebo

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

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received study drug in the clinical study TDU13475

You may qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

Investigational Site Number 276001

Berlin, 10117, Germany

Location

Related Publications (1)

• Albach FN, Geier C, Keicher C, Posch MG, Schreiber SJ, Grutz G, Akyuz L, Luo X, Le-Halpere A, Truffinet P, Wagner F. Phase 1 Trials of Gatralimab, a Next-Generation Humanized Anti-CD52 Monoclonal Antibody, in Participants with Progressive Multiple Sclerosis. Neurol Ther. 2024 Dec;13(6):1607-1625. doi: 10.1007/s40120-024-00659-w. Epub 2024 Sep 9.

  PMID: 39251561 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 10, 2014
• Study Start: January 12, 2015
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)