2-week dc of MTX and Influenza Vaccination in RA

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT02897011
• Date of registration: 07/09/2016
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: 2-week dc of MTX and Influenza Vaccination in RA 2 wk MTX
• Scientific title: Effect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial
• Date of first enrolment: September 2016
• Target sample size: 318
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02897011
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males or females = 19 years and < 65 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

- Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine
2 weeks before the study

- Blood transfusion within 6 months

- Active rheumatoid arthritis necessitating a recent change in the drug regimen

- 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Methotrexate

Influenza

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Primary Outcome(s)

Proportion of satisfactory vaccine response [Time Frame: 4 weeks]

Secondary Outcome(s)

Proportion of patients who experience increase in disease activity [Time Frame: 4 weeks]

Proportion of patients who have = 4-fold increase in post-vaccination titer in = 3 of 4 influenza strains [Time Frame: 4 weeks]

Change from baseline in DAS28-4 (CRP) at 4 weeks after vaccination [Time Frame: 4 weeks]

Change from baseline in titer (in GMT) for each strain [Time Frame: 4 weeks]

Proportion of seroprotection for each strain [Time Frame: 4 weeks]

Secondary ID(s)

SNUH-IMJ-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors