Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada (LEMTRADA-ITP)
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|ClinicalTrials.gov Identifier: NCT03784898|
Recruitment Status : Completed
First Posted : December 24, 2018
Results First Posted : July 20, 2020
Last Update Posted : March 28, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Blood draw for future biomarker analysis||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Collection of Blood Samples From Patients With Relapsing Forms of Multiple Sclerosis (RMS) Who Have Developed Immune Thrombocytopenic Purpura (ITP) After LEMTRADA® Treatment|
|Actual Study Start Date :||February 8, 2019|
|Actual Primary Completion Date :||December 11, 2019|
|Actual Study Completion Date :||December 11, 2019|
Participants Diagnosed With ITP
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
Each participant was required to undergo blood draw for future genetic testing and biomarker analysis as mentioned in the informed consent form (ICF).
- Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis [ Time Frame: 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.
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): NCT03784898
|United States, California|
|Investigational Site Number 8400001|
|Los Angeles, California, United States, 90094|
|Study Director:||Clinical Sciences & Operations||Sanofi|