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Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Vaccine Response Impaired

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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 methotrexate 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-, hen-protein- 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:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

seroconversion after the first dose/doses of hepatitis A vaccine

Outcome Description:

ELISA-titers are determined before the first dose/doses and at 1 month later

Outcome Time Frame:

one month after the first dose/doses

Safety Issue:

No

Principal Investigator

lars rombo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska Institutet

Authority:

Sweden: Medical Products Agency

Study ID:

Rombo - 2

NCT ID:

NCT01446978

Start Date:

September 2011

Completion Date:

August 2012

Related Keywords:

  • Vaccine Response Impaired
  • hepatitis A vaccine
  • TNF-alfa inhibitory drugs
  • Rheumatoid arthritis
  • methotrexate
  • Arthritis, Rheumatoid
  • Hepatitis
  • Hepatitis A

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