NCT01131910

TBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Sormland County Council, Sweden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Rheumatoid Arthritis
• Exposed to TBE-virus
• Immunosuppression

Interventions

Type	Name	Description
BIOLOGICAL	TBE-vaccine	Solution of 0.5 ml for intramuscular use. Given in 2 doses separated by 1 month to healthy individuals less than 60 years old. (3 doses 0+1+3 months to those are 60 and above in Sweden)
BIOLOGICAL	TBE-vaccine	Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year
BIOLOGICAL	Vaccination against TBE	0.5 ml im at 0 and 1 month ( less than 60 years old) or 0 and 1 and 3 months (at least 60 years old)

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-05-27
• Last updated: 2011-05-25

Locations

6 sites across 2 countries: Finland, Sweden