Phase 4
Completed N=13
Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada
Source: ClinicalTrials.gov NCT03784898 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis — 12; 12; 12; 12 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis |
12; 12; 12; 12; 13; 13 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03784898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.