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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 : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Multiple Sclerosis
Intervention Other: Blood draw for future biomarker analysis
Enrollment 13
Recruitment Details The study was conducted at a single site in the United States. A total of 14 participants were screened between 8 February 2019 to 11 December 2019, of which,1 participant was screen failure. Screen failures was mainly due to inclusion criteria not met.
Pre-assignment Details A total of 13 participants were enrolled in the study.
Arm/Group Title Participants Diagnosed With ITP
Hide Arm/Group Description Participants with Relapsing Forms of Multiple Sclerosis (RMS) who developed Immune thrombocytopenic purpura (ITP) after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.
Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Participants Diagnosed With ITP
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
Analysis was performed on all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
48.2  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
10
  76.9%
Male
3
  23.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
Hide Description 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.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled population.
Arm/Group Title Participants Diagnosed With ITP
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
DNA PAXgene (tube 1)
12
  92.3%
DNA PAXgene (tube 2)
12
  92.3%
RNA PAXgene (tube 1)
12
  92.3%
RNA PAXgene (tube 2)
12
  92.3%
EDTA for PBMCs (tube 1)
13
 100.0%
EDTA for PBMCs (tube 2)
13
 100.0%
EDTA for PBMCs (tube 3)
13
 100.0%
EDTA for PBMCs (tube 4)
13
 100.0%
EDTA for PBMCs (tube 5)
5
  38.5%
SST tube
12
  92.3%
K2EDTA tube
12
  92.3%
Time Frame Adverse Event data was collected from the signature of the Informed consent form until the end of the study (i.e. up to 307 days)
Adverse Event Reporting Description Analysis was performed on all enrolled participants.
 
Arm/Group Title Participants Diagnosed With ITP
Hide Arm/Group Description 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.
All-Cause Mortality
Participants Diagnosed With ITP
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Serious Adverse Events
Participants Diagnosed With ITP
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants Diagnosed With ITP
Affected / at Risk (%)
Total   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT03784898    
Other Study ID Numbers: ASY15905
U1111-1225-1333
First Submitted: December 20, 2018
First Posted: December 24, 2018
Results First Submitted: July 2, 2020
Results First Posted: July 20, 2020
Last Update Posted: July 20, 2020