Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada

NCT03784898 | Completed Phase 4 Results

• 2 other identifiers: ASY15905U1111-1225-1333
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To collect blood samples in a new cohort of Relapsing Forms of Multiple Sclerosis (RMS) participants who had developed immune thrombocytopenic purpura (ITP) after LEMTRADA treatment, for future Deoxyribonucleic acid (DNA) analysis as part of a global biomarker project assessing pre-identified candidate single nucleotide polymorphisms (SNPs) associated to the development of ITP after LEMTRADA treatment in RMS participants.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis

  Each participant provided a maximum total of 69 milliliter of whole blood sample. Samples were collected in the following order: 1. Deoxyribonucleic acid (DNA) Paired box (PAX)gene tubes (2 tubes), 2. Ribonucleic acid (RNA) PAXgene tubes (2 tubes), 3. Ethylenediaminetetraacetic acid (EDTA) tubes for peripheral blood mononuclear cells (PBMCs) (5 tubes), 4. Serum Separator tube (SST) (1 tube), and 5. Dipotassium Ethylenediaminetetraacetic acid (K2EDTA) tube (1 tube); where DNA PAXgene tubes were used for DNA preparation, RNA PAXgene tubes for RNA preparation, EDTA for PBMC isolation, SST tubes for serum preparation and K2EDTA for plasma preparation. DNA was extracted from peripheral blood for future analysis.

  Baseline (Day 1)

Study Arms (1)

Participants Diagnosed With ITP

OTHER

Participants with RMS who developed ITP after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.

Other: Blood draw for future biomarker analysis

Interventions

Blood draw for future biomarker analysis OTHER

Each participant was required to undergo blood draw for future genetic testing and biomarker analysis as mentioned in the informed consent form (ICF).

Participants Diagnosed With ITP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adult participants who had been treated with LEMTRADA, with development of ITP subsequent to treatment. Participants does not need to be currently on LEMTRADA treatment.
• Participants who had signed the study ICF.

You may not qualify if:

• \- Not applicable
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

Investigational Site Number 8400001

Los Angeles, California, 90094, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: February 8, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: March 28, 2022
• Results First Posted: July 20, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)