Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This prospective, observational clinical study aims to longitudinally assess peripheral immune cell profiles of patients with relapsing-remitting multiple sclerosis (RRMS) receiving anti-CD20 therapy with ofatumumab (OFA), ocrelizumab (OCR), ublituximab (UBX), and rituximab (RTX). Throughout the study, clinical data - including relapse events, patient scores, and neuropsychological parameters - will be collected, along with results from imaging techniques such as Optical Coherence Tomography (OCT) and Magnetic Resonance Imaging (MRI). This clinical data will be combined with immunological analyses, including multidimensional flow cytometry (mFC), bulk RNA sequencing (bulk-Seq), T and B cell receptor sequencing (TCR/BCR-Seq), proteomics, and immunoglobulin analysis. This approach aims to enable a detailed characterization of changes in the immune cell repertoire and their impact on the clinical disease course.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
View:

• Diagnosed relapsing-remitting multiple sclerosis (RRMS) according to 2017 revised McDonald criteria

• Current treatment with B cell modulating therapies or initiation/transition to B cell modulating therapies according to the Summary of Product Characteristics (SmPC)

• EDSS score of 0.0 to 7.0

Locations
Other Locations
Germany
Heinrich-Heine University, Duesseldorf
RECRUITING
Düsseldorf
Contact Information
Primary
Saskia Räuber, MD
SaskiaJanina.Raeuber@med.uni-duesseldorf.de
+492118117889
Backup
Alice Willison, MD
AliceGrizzel.Willison@med.uni-duesseldorf.de
+492118117889
Time Frame
Start Date: 2021-10-27
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Cohort 1 (C1; basic cohort)
Participants will be seen every 6 months up until month 24, then every 12 months. The following parameters will be collected: demographic data, disease characteristics incl. EDSS and MRI data, serum samples, and PBMCs. Furthermore, SF-36 and FSMC are documented.
Cohort 2 (C2; in-depth cohort)
In addition to the parameters collected for C1, participants of C2 will receive: clinical evaluation incl. EDSS and sampling of serum and PBMCs at months 1 and 3, MFSC every 6 months, and OCT as well as NPT every 12 months.
Related Therapeutic Areas
Sponsors
Leads: Heinrich-Heine University, Duesseldorf
Collaborators: Novartis

This content was sourced from clinicaltrials.gov