LEMTRADA-ITP: Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada
Study Details
Study Description
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 |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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
Primary Outcome Measures
- 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site Number 8400001 | Los Angeles | California | United States | 90094 |
Sponsors and Collaborators
- Genzyme, a Sanofi Company
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
More Information
Publications
None provided.- ASY15905
- U1111-1225-1333
Study Results
Participant Flow
| 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 Detail | A total of 13 participants were enrolled in the study. |
| Arm/Group Title | Participants Diagnosed With ITP |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Participants Diagnosed With ITP |
|---|---|
| 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 Participants | 13 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
48.2
(7.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
76.9%
|
| Male |
3
23.1%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
13
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on all enrolled population. |
| Arm/Group Title | Participants Diagnosed With ITP |
|---|---|
| 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. |
| Measure Participants | 13 |
| 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%
|
| EDTA for PBMCs (tube 2) |
13
100%
|
| EDTA for PBMCs (tube 3) |
13
100%
|
| EDTA for PBMCs (tube 4) |
13
100%
|
| EDTA for PBMCs (tube 5) |
5
38.5%
|
| SST tube |
12
92.3%
|
| K2EDTA tube |
12
92.3%
|
Adverse Events
| 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 | |
| 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 (%) | # Events | |
| Total | 0/13 (0%) | |
Serious Adverse Events |
||
| Participants Diagnosed With ITP | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Participants Diagnosed With ITP | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Trial Transparency Team |
|---|---|
| Organization | Sanofi |
| Phone | 800-633-1610 ext 1# |
| Contact-US@sanofi.com |
- ASY15905
- U1111-1225-1333