Back to resultsTBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs
Primary Purpose
Rheumatoid Arthritis, Exposed to TBE-virus, Immunosuppression
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TBE-vaccine
TBE-vaccine
Vaccination against TBE
Sponsored by
About this trial
This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, TBE-vaccine, Immunosuppression
Eligibility Criteria
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
Sites / Locations
- Dept infectious diseases
- Dept infectious diseases
- Dept. infectious diseases
- Department of infectious diseases
- Dept infectious diseases
- Department of infectious diseases
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaccination against TBE
Arm Description
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
Outcomes
Primary Outcome Measures
Seroconversion rate
The humoral response to TBE-vaccine
Secondary Outcome Measures
Full Information
NCT ID
NCT01131910
First Posted
May 24, 2010
Last Updated
May 24, 2011
Sponsor
Sormland County Council, Sweden
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT01131910
Brief Title
TBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs
Official Title
Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sormland County Council, Sweden
Collaborators
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Exposed to TBE-virus, Immunosuppression
Keywords
Rheumatoid arthritis, TBE-vaccine, Immunosuppression
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccination against TBE
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
TBE-vaccine
Other Intervention Name(s)
ATC-code J07B A01
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
TBE-vaccine
Other Intervention Name(s)
J07B A01
Intervention Description
Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year
Intervention Type
Biological
Intervention Name(s)
Vaccination against TBE
Intervention Description
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 Outcome Measure Information:
Title
Seroconversion rate
Description
The humoral response to TBE-vaccine
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Rombo, MD Professor
Organizational Affiliation
Somland county council
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept infectious diseases
City
Helsingfors
ZIP/Postal Code
00029
Country
Finland
Facility Name
Dept infectious diseases
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Dept. infectious diseases
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Department of infectious diseases
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Dept infectious diseases
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Department of infectious diseases
City
Örebro
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
TBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs
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