Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586177
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Understanding the durable Effect Concept of B-cell Modulating Therapies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Understanding the durable Effect Concept of B-cell Modulating Therapies
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REBELLION-MS
Brief 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 TCRBCR-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
Detailed Description:
B cell targeted therapies have become a key element in the treatment of multiple sclerosis due to their effectiveness in rapid and long-lasting depletion of B cells in peripheral blood PB significantly reducing relapse rates and disability progression The monoclonal antibodies OFA OCR UBX and RTX target the B cell surface protein CD20 however it is unclear how B cell depletion and subsequent repopulation allows for immune system reconstitution and how other immune cell populations are affected by these therapies Furthermore the relevance of immune cell changes - beyond B cell depletion - for clinical disease stability remains insufficiently understood
By collecting comprehensive and structured prospective clinical data alongside immunological analyses this study aims for a better understanding of immunological changes in RRMS patients receiving anti-CD20 therapies and the implications of those alterations in immune cell profiles on the clinical disease course REBELLION-MS plans for two patient cohorts cohort 1 C1 basic cohort and cohort 2 C2 in-depth cohort Participants in C1 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 Expanded Disability Status Scale EDSS and magnetic resonance imaging MRI data serum samples and Peripheral Blood Mononuclear Cells PBMCs Furthermore Short Form-36 SF-36 and Fatigue Scale for Motor and Cognitive Functions FSMC are documented Participants of C2 will receive additional evaluations clinical evaluation incl EDSS and sampling of serum and PBMCs at months 1 and 3 Multiple sclerosis functional composite MFSC every 6 months and optical coherence tomography OCT as well as neuropsychological assessment NPT every 12 months Serum samples and PBMCs will be analyzed by mFC bulk-Seq TCRBCR-Seq and proteomics among other methods
By collecting comprehensive and structured prospective clinical data alongside immunological analyses this study aims for a better understanding of immunological changes in RRMS patients receiving anti-CD20 therapies and the implications of those alterations in immune cell profiles on the clinical disease course REBELLION-MS plans for two patient cohorts cohort 1 C1 basic cohort and cohort 2 C2 in-depth cohort Participants in C1 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 Expanded Disability Status Scale EDSS and magnetic resonance imaging MRI data serum samples and Peripheral Blood Mononuclear Cells PBMCs Furthermore Short Form-36 SF-36 and Fatigue Scale for Motor and Cognitive Functions FSMC are documented Participants of C2 will receive additional evaluations clinical evaluation incl EDSS and sampling of serum and PBMCs at months 1 and 3 Multiple sclerosis functional composite MFSC every 6 months and optical coherence tomography OCT as well as neuropsychological assessment NPT every 12 months Serum samples and PBMCs will be analyzed by mFC bulk-Seq TCRBCR-Seq and proteomics among other methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None