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

May 24, 2011 updated by: Sormland County Council, Sweden

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsingfors, Finland, 00029
        • Dept infectious diseases
  • Sweden
      • Eskilstuna, Sweden, 631 88
        • Dept infectious diseases
      • Eskilstuna, Sweden, 631 88
        • Dept. infectious diseases
      • Stockholm, Sweden, 17176
        • Department of Infectious Diseases
      • Uppsala, Sweden, 751 85
        • Dept infectious diseases
      • Örebro, Sweden
        • Department of Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate
Time Frame: 1 year
The humoral response to TBE-vaccine
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sormland County Council, Sweden

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Lars Rombo, MD Professor, Somland county council

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 27, 2010

Study Record Updates

Last Update Posted (Estimate)

May 25, 2011

Last Update Submitted That Met QC Criteria

May 24, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-019438-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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