NCT03784898

Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada

Collection of Blood Samples From Patients With Relapsing Forms of Multiple Sclerosis (RMS) Who Have Developed Immune Thrombocytopenic Purpura (ITP) After LEMTRADA® Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-02-08
• Primary completion: 2019-12-11
• Completion: 2019-12-11
• First posted: 2018-12-24
• Last updated: 2022-03-28
• Results posted: 2020-07-20

Locations

1 site across 1 country: United States