MTX Discontinuation and Vaccine Response

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT02748785
• Date of registration: 08/09/2015
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: MTX Discontinuation and Vaccine Response
• Scientific title: Effect of Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial
• Date of first enrolment: September 2015
• Target sample size: 277
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02748785
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males or females > 18 years 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Methotrexate

Biological: Seasonal Influenza vaccine

Primary Outcome(s)

Proportion of seroresponse [Time Frame: 8 weeks]

Secondary Outcome(s)

Change from baseline in Disease Activity Score (DAS) 28-(CRP) [Time Frame: 8 weeks]

Change from baseline in antibody titer [Time Frame: 8 weeks]

Proportion of seroprotection [Time Frame: 8 weeks]

Secondary ID(s)

SNUH-IMJ-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors