Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs

NCT01131910 Phase 2 COMPLETED

The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. The investigators aim to detect a difference of at least 10 % compared to healthy individuals (historical controls) in protection when analysed with serology. If the investigators detect a difference, the investigators will continue to explore whether protection can be achieved by additional doses

Details

Lead sponsor	Sormland County Council, Sweden
Phase	Phase 2
Status	COMPLETED
Enrolment	68
Start date	2010-05
Completion	2011-05

Conditions

• Rheumatoid Arthritis
• Exposed to TBE-virus
• Immunosuppression

Interventions

• TBE-vaccine
• TBE-vaccine
• Vaccination against TBE

Primary outcomes

• Seroconversion rate — 1 year
  The humoral response to TBE-vaccine

Countries

Finland, Sweden