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

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131910
• Other study ID #: 2010-019438-28
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2010
• Last updated: May 24, 2011
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: April 2010
• Source: Sormland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Exposed to TBE-virus
• Immunosuppression
• Rheumatoid Arthritis

Intervention

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)
• TBE-vaccine
Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year
• 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)

Locations

Country	Name	City	State
Finland	Dept infectious diseases	Helsingfors
Sweden	Dept infectious diseases	Eskilstuna
Sweden	Dept. infectious diseases	Eskilstuna
Sweden	Department of infectious diseases	Örebro
Sweden	Department of infectious diseases	Stockholm
Sweden	Dept infectious diseases	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Sormland County Council, Sweden	Karolinska Institutet

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate	The humoral response to TBE-vaccine	1 year	No