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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030731

Enrollment

120

Registered

2022-11-18

Start date

2022-11-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis Vaccination effect M06 M05

Interventions

Group 1: RA patients with Filgotinib treatment Before and 7 days, 3 and 6 months after vaccination against SARS-CoV-2, blood samples willl be taken. B- und plasmacell populations (unspecific and SARS-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 2. Cellular response: significant increase of protective T and B cells in patients as compared to baseline and study data from healthy controls 3. Qualitative response: Significant difference in quality of produced Anti-SARS-CoV-2-antibodies as measured by glycosylation	—

Measure

Time frame

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. 2. Cellular response: significant increase of protective T and B cells in patients as compared to baseline and study data from healthy controls 3. Qualitative response: Significant difference in quality of produced Anti-SARS-CoV-2-antibodies as measured by glycosylation

—

Countries

Germany

Contacts

Public ContactUlf Geisen

UKSH Kiel/1. medizinische Klinik/Rheumatologie

ugeisen@rheuma.uni-kiel.de0431 500 22253

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026