One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis.

Study Overview
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Brief Summary
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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.

Official Title
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Effect of One-week vs Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

Conditions
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Rheumatoid Arthritis, Autoimmune Diseases, Influenza, Vaccine Reaction

Intervention / Treatment
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* Drug: MTX-hold


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MTX 1 week hold<br>Patients who will hold MTX for 1 week after an influenza vaccine. | Drug: MTX-hold<br>* Temporary discontinuation of methotrexate for 1 or 2 weeks<br>|
| Active Comparator: MTX 2 week hold<br>Patients who will hold MTX for 2 weeks after an influenza vaccine. | Drug: MTX-hold<br>* Temporary discontinuation of methotrexate for 1 or 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of satisfactory vaccine response | as ≥ 4-fold increase in post-vaccination titer in ≥ 2 of 4 influenza strains at 4 weeks after vaccination | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportio0n of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains | 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 | 4 weeks and 16 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methotrexate, rheumatoid arthritis, influenza