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

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Blood draw for future biomarker analysis

• Registration Number: NCT03784898
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Detailed Description

One to 70 days, as screening and inclusion visit(s) were performed the same day or on separate days with a maximum timeframe of 30 days apart. One visit was required for blood draw. However, if a second visit occured, it took place within 40 days of the first visit.

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Study Start: 2019-02-08
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-11
• Results First Submitted: 2020-07-02
• Results First Submitted QC: 2020-07-02
• Results First Posted: 2020-07-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants Diagnosed With ITP	Blood draw for future biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis	Baseline (Day 1)	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.

Trial Locations

Locations (1)

Investigational Site Number 8400001; 🇺🇸 Los Angeles, California, United States