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
1 other identifier
interventional
68
2 countries
6
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started May 2010
Shorter than P25 for phase_2 rheumatoid-arthritis
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 25, 2011
April 1, 2010
1 year
May 24, 2010
May 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rate
The humoral response to TBE-vaccine
1 year
Study Arms (1)
Vaccination against TBE
EXPERIMENTALLess 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
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs
- Interest to be vaccinated
- Written consent
- Age 18 years or more
You may not qualify if:
- Previous TBE-infection
- Previous Vaccination with TBE
- Pregnancy
- Breast feeding
- Treatment with rituximab the last 9 months
- Inability to follow study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sormland County Council, Swedenlead
- Karolinska Institutetcollaborator
Study Sites (6)
Dept infectious diseases
Helsingfors, 00029, Finland
Dept infectious diseases
Eskilstuna, 631 88, Sweden
Dept. infectious diseases
Eskilstuna, 631 88, Sweden
Department of infectious diseases
Örebro, Sweden
Department of infectious diseases
Stockholm, 17176, Sweden
Dept infectious diseases
Uppsala, 751 85, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Rombo, MD Professor
Somland county council
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 27, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 25, 2011
Record last verified: 2010-04