Autoimmune Diseases, Influenza, Rheumatoid Arthritis, Vaccine Reaction
Conditions
Keywords
rheumatoid arthritis, methotrexate, influenza
Brief summary
This is a multi-center, randomized, single-blinded, prospective, parallel group intervention study to investigate whether methotrexate (MTX) discontinuation for 1 week is non-inferior to MTX discontinuation for 2 weeks in regard to satisfactory vaccination response to a seasonal influenza.
Interventions
DRUGMTX-hold
Temporary discontinuation of methotrexate for 1 or 2 weeks
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Single-blinded study. Investigators assessing disease activity will be blinded to the treatment arm.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males or females ≥ 19 years of age at time of consent * Have a diagnosis of RA per ACR criteria * Must understand and voluntarily sign an informed consent form including writing consent for data protection * Stable doses of methotrexate over the preceding 6 weeks
Exclusion criteria
* Pregnant or lactating females * Previous anaphylactic response to vaccine components or to egg. * Acute infection with T \>38°C at the time of vaccination * History of Guillain-Barre syndrome or demyelinating syndromes * Blood transfusion within 6 months * Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease * Any condition including laboratory abnormality which places the subject at unacceptable risk * Subjects who decline to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of satisfactory vaccine response | 4 weeks | as ≥ 4-fold increase in post-vaccination titer in ≥ 2 of 4 influenza strains at 4 weeks after vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportio0n of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains | 4 weeks and 16 weeks | Proportion of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains at 4 weeks and 16 weeks after vaccination |
| Proportion of seroprotection for each strain | 4 weeks and 16 weeks | — |
| Change from baseline in titer (in GMT) | 4 weeks and 16 weeks | — |
| Change from baseline in DAS28-4 (CRP) | 4 weeks and 16 weeks | — |
| Disease flare | 4 weeks and 16 weeks | — |
Countries
South Korea
Outcome results
None listed