This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Karolinska Institutet
Information provided by:
Sormland County Council, Sweden Identifier:
First received: May 24, 2010
Last updated: May 24, 2011
Last verified: April 2010
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

Condition Intervention Phase
Rheumatoid Arthritis Exposed to TBE-virus Immunosuppression Biological: TBE-vaccine Biological: Vaccination against TBE Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs

Resource links provided by NLM:

Further study details as provided by Sormland County Council, Sweden:

Primary Outcome Measures:
  • Seroconversion rate [ Time Frame: 1 year ]
    The humoral response to TBE-vaccine

Enrollment: 68
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccination against TBE

Less than 60 years old: Two doses of TBE- vaccine separated by a month and a third dose 12 months after the first dose

60 years and above: Three doses, given at 0+1+3 months and a 4 th dose 12 months after the first dose

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)
Other Name: ATC-code J07B A01
Biological: TBE-vaccine
Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year
Other Name: J07B A01
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs
  • Interest to be vaccinated
  • Written consent
  • Age 18 years or more

Exclusion Criteria:

  • Previous TBE-infection
  • Previous Vaccination with TBE
  • Pregnancy
  • Breast feeding
  • Treatment with rituximab the last 9 months
  • Inability to follow study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01131910

Dept infectious diseases
Helsingfors, Finland, 00029
Dept infectious diseases
Eskilstuna, Sweden, 631 88
Dept. infectious diseases
Eskilstuna, Sweden, 631 88
Department of infectious diseases
Stockholm, Sweden, 17176
Dept infectious diseases
Uppsala, Sweden, 751 85
Department of infectious diseases
Örebro, Sweden
Sponsors and Collaborators
Sormland County Council, Sweden
Karolinska Institutet
Principal Investigator: Lars Rombo, MD Professor Somland county council
  More Information

Responsible Party: Professor Lars Rombo, Sormland County Council Identifier: NCT01131910     History of Changes
Other Study ID Numbers: 2010-019438-28
Study First Received: May 24, 2010
Last Updated: May 24, 2011

Keywords provided by Sormland County Council, Sweden:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on June 23, 2017