Hepatitis A vaccine in patients with immunomodulative drugs

Conditions: Patients with rheumatoid arthritis treated with immunosuppressive medication
MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
MedDRA version: 12.1Level: LLTClassification code 10054980Term: Immunosuppressant drug therapy
MedDRA version: 12.1Level: LLTClassification code 10063430Term: Hepatitis A immunisation

Registration Number: EUCTR2009-016055-22-SE

Lead Sponsor: HY, HUS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 380

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Treatment with rituximab within 9 months before study start
Known previous hepatitis A infection
Previous vaccination against hepatitis A
Egg-, henprotein- or formaldehyde allergy
Pregnancy or lactation
Excessive use of alcohol
An other vaccine given within a month
Mentally retardedness
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
Immunological abnormality: immunosupression or autoimmune disease
An other vaccine given within a month
Mentally retardedness
Acute disease at the time of examination (fever > 38 degrees)
Employees of the researchers
Not suitable for other reason in the investigator's opinion (other serious disease, i.e. AIDS/HIV-positiv, cancer with ongoing cytostatic treatment)