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Trial record 1 of 1 for:    ASY15905
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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 Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Blood draw for future biomarker analysis Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • 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.

Exclusion criteria:

- Not applicable

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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Investigational Site Number 8400001
Los Angeles, California, United States, 90094
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Sanofi ( Genzyme, a Sanofi Company ):
Study Protocol  [PDF] May 24, 2019
Statistical Analysis Plan  [PDF] January 9, 2020

More Information
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03784898    
Other Study ID Numbers: ASY15905
U1111-1225-1333
First Posted: December 24, 2018    Key Record Dates
Results First Posted: July 20, 2020
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases