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

This study has been completed.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by:
Sormland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01131910
First received: May 24, 2010
Last updated: May 24, 2011
Last verified: April 2010
History of Changes

May 24, 2010
May 24, 2011
May 2010
May 2011   (final data collection date for primary outcome measure)
Seroconversion rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The humoral response to TBE-vaccine
Same as current
Complete list of historical versions of study NCT01131910 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Rheumatoid Arthritis
  • Exposed to TBE-virus
  • Immunosuppression
  • 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)
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

Interventions:
  • Biological: TBE-vaccine
  • Biological: TBE-vaccine
  • Biological: Vaccination against TBE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Sweden
 
NCT01131910
2010-019438-28
Yes
Professor Lars Rombo, Sormland County Council
Sormland County Council, Sweden
Karolinska Institutet
Principal Investigator: Lars Rombo, MD Professor Somland county council
Sormland County Council, Sweden
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP