COvid-19: Influence of JAK-inhibitors on the vaccination efficiency against SARS-CoV-2 - Comparison of pan-JAK- and selective JAK1-inhibitors

Recruiting

• Conditions: Rheumatoid ArthritisVaccination effect; M06; M05; Other rheumatoid arthritis; Seropositive rheumatoid arthritis

• Registration Number: DRKS00030731
• Lead Sponsor: KSH Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

patients diagnosed with rheumatoid arthritis fulfilling ACR criteria who use either Filgotinib, Baracitinib, Upadicitinib, Tofacitinib or a TNF blocker. Inactive or low disease activity (DAS28-CRP<4)
A vaccination against SARS-COV-2 with omicron-adapted mRNA vaccines is planned.

Exclusion Criteria

malignant diseases, other autoimmune diseases like CED, MS, diabetes type 1, prednisolone dose above 7.5mg/d

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study will be reached, if 50% of patients using JAK inhibitors or 50% of patients of a specific JAKi-group show 50% decreased SARS-CoV-2 antibody titres compared to the TNF-blocker group and healthy controls (data for healthy controls available).

Secondary Outcome Measures

Name	Time	Method
1. Serological response: significant increase of SARS-CoV-2 specific antibody titres and plasma cells after the booster immunisation as compared to baseline of healthy controls.<br>2. Cellular response: significant increase of protective T and B cells in patients as compared to baseline and study data from healthy controls<br>3. Qualitative response: Significant difference in quality of produced Anti-SARS-CoV-2-antibodies as measured by glycosylation<br>