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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Exposed to TBE-virus Immune System Diseases Immunosuppression Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept infectious diseases, Helsingfors, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TBE-vaccine

Biological

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 names: ATC-code J07B A01

Vaccination against TBE

Biological

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)

Primary outcomes

Seroconversion rate

Time frame: 1 year

The humoral response to TBE-vaccine

Sponsors and collaborators

Lead sponsor

Sormland County Council, Sweden

Other

Collaborators

Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: May 27, 2010
Registry last updated: May 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed