Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
Methods: Parameters registered at baseline were: age, sex, duration of disease, medications,
activity of disease (Visual Analogue Scale=VAS, Health Assessment Questionnaire Disability
Index = HAQ, Disease Activity Score =DAS-28, CRP and total IgG in plasma). Hepatitis A
vaccine (Epaxal or Havrix) were given at 0 and 6 months. Hepatitis A virus (HAV) antibodies
is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative
HAV IgG, using the HAVAb-IgG Architect System, and by the HAVAB 2.0 assay on the AxSYM
machine from Abbott. The level of protective immunity to HAV is defined as HAV IgG >
10mIU/mL.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
seroconversion after the first dose/doses of hepatitis A vaccine
ELISA-titers are determined before the first dose/doses and at 1 month later
one month after the first dose/doses
No
lars rombo, MD
Principal Investigator
Karolinska Institutet
Sweden: Medical Products Agency
Rombo - 2
NCT01446978
September 2011
August 2012
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