Measurements of CNS-reactive B cells and their specificity in the blood of ocrelizumab-treated patients

Recruiting

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00029110
• Lead Sponsor: Institut für Neuroanatomie, Universitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

RRMS, Treatment with ocrevus

Exclusion Criteria

Lack of compliance

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EDSS increase >1 for patients with EDSS from 0,5-5 at study baseline<br>EDSS increase >0,5 for patients with EDSS >5 at baseline

Secondary Outcome Measures

Name	Time	Method
1) Absolute value of EDSS<br>2) EDSS change to baseline<br>3) Time to disease worsening confirmed after 12 weeks<br>4) Relative change in EDSS at any point during the study compared to previous measurement set in relation to the relative change in CNS-reactive B cells in the blood from previous measurement as measured by B-cell ELISPOT<br>5) Relative change in EDSS at any point during the study compared to study baseline set in relation to the relative change in CNS-reactive B cells in the blood from previous measurement as measured by B-cell ELISPOT<br>6) Annualized relapse rate (ARR)<br>7) Absolute value in 9-hole peg test performance<br>8) Change in 9-hole peg test performance to baseline<br>9) Changes in the antibody specificity as measured by proteome array<br>10) Body mass index