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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Rheumatoid Arthritis Exposed to TBE-virus Immunosuppression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

TBE-vaccine

Intervention Type BIOLOGICAL

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)

TBE-vaccine

Intervention Type BIOLOGICAL

Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year

Vaccination against TBE

Intervention Type BIOLOGICAL

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)

Interventions

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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)

Intervention Type BIOLOGICAL

TBE-vaccine

Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year

Intervention Type 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)

Intervention Type BIOLOGICAL

Other Intervention Names

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ATC-code J07B A01 J07B A01

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No