Collection of Blood Samples From Patients With Relapsing MS Who Develo
Collection of Blood Samples From Patients With Relapsing Forms of Multiple Sclerosis (RMS) Who Have Developed Immune Thrombocytopenic Purpura (ITP) After LEMTRADA® Treatment
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Blood draw for future biomarker analysis
Results by group
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
Baseline (Day 1)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Participants Diagnosed With ITP | 12 Participants | 13 | |
| Participants Diagnosed With ITP | 12 Participants | 13 | |
| Participants Diagnosed With ITP | 12 Participants | 13 | |
| Participants Diagnosed With ITP | 12 Participants | 13 | |
| Participants Diagnosed With ITP | 13 Participants | 13 | |
| Participants Diagnosed With ITP | 13 Participants | 13 | |
| Participants Diagnosed With ITP | 13 Participants | 13 | |
| Participants Diagnosed With ITP | 13 Participants | 13 | |
| Participants Diagnosed With ITP | 5 Participants | 13 | |
| Participants Diagnosed With ITP | 12 Participants | 13 | |
| Participants Diagnosed With ITP | 12 Participants | 13 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Participants Diagnosed With ITP | 13 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
Baseline (Day 1)
Who could take part
Relapsing MS · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Feb 2019
Main results due
Dec 2019
Finished
Dec 2019
Results posted
Jul 2020