Effect of TNFalpha blockade on the induction of specific B cell responses in vivo, using human spondyloarthropathy as model.
- Conditions
- Spondyloarthropathy
- Registration Number
- EUCTR2004-001113-33-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
* Spondyloarthropathy patients
* Treated with infliximab, fulfilling the criteria for repayment of infliximab
* No concomitant medication, except for NSAIDs
* Negative TBC screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
* Under 18 years
* Severe concomitant disease
* High risk for infections
* previous vaccination for pneumococci and hepatitis B
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: * Analysing the mechanisms explaining the more pronounced induction of antinuclear antibodies after infliximab than etanercept.<br>* Analysing the influence of TNFalpha blockade on isotype switching.;Secondary Objective: Assess the efficacy of vaccination during TNFalpha blockade treatment.;Primary end point(s): Serum antibody titers
- Secondary Outcome Measures
Name Time Method