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
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131910

Locations
Finland
Dept infectious diseases
Helsingfors, Finland, 00029
Sweden
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
Investigators
Principal Investigator: Lars Rombo, MD Professor Somland county council
  More Information

No publications provided

Responsible Party: Professor Lars Rombo, Sormland County Council
ClinicalTrials.gov Identifier: NCT01131910     History of Changes
Other Study ID Numbers: 2010-019438-28
Study First Received: May 24, 2010
Last Updated: May 24, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sormland County Council, Sweden:
Rheumatoid arthritis
TBE-vaccine
Immunosuppression

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014