Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
18 Years
N/A
Both
Response to Hepatitis A Vaccine
Trial Information
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.
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis
- TNF-alfa blocker and / or methotraxate in use as a medication against RA
- A desire to get protected against hepatitis A
- Men and women age 18-65 years
- Written informed consent
- Women of childbearing potential must use effective contraception -
Exclusion Criteria:
- Treatment with rituximab within 9 months before study start
- Known previous hepatitis A infection
- Previous vaccination against hepatitis A
- Allergy to eggs or formaldehyde
- Pregnancy or lactation
- Excessive use of alcohol
- Mental retardation
- Acute disease at the time of examination (fever > 38 degrees)
- Volunteer works as an employee of the researchers
- Previous vaccination against hepatitis A
- Egg-, henprotein- or formaldehyde allergy
- Pregnancy or lactation
- Excessive use of alcohol
- Another vaccine given within a month
- Acute disease at the time of examination (fever > 38 degrees)
- Not suitable for other reason in the investigator's opinion (other serious disease,
i.e. AIDS/HIV-positive, cancer with ongoing cytostatic treatment)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
seroconversion after a single dose of hepatitis A vaccine
Outcome Description:
ELISA-titers are determined before first dose and at 1 and 6 months later
Outcome Time Frame:
one month after dose
Safety Issue:
No
Principal Investigator
lars rombo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Karolinska Institutet
Authority:
Sweden: Medical Products Agency
Study ID:
EU 2009-016055-22
NCT ID:
NCT01360970
Start Date:
September 2009
Completion Date:
May 2011
Related Keywords:
- Response to Hepatitis A Vaccine
- hepatitis A vaccine
- TNF-alfa inhibitory drugs
- Rheumatoid arthritis
- methotrexate
- Arthritis, Rheumatoid
- Hepatitis
- Hepatitis A
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