Effect of TNFalpha blockade on the induction of specific B cell responses in vivo, using human spondyloarthropathy as model.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001113-33-BE

Enrollment

Registered

2005-07-13

Start date

2004-10-13

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthropathy

Interventions

Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Infliximab Concentration unit: mg/ml milligram(s)/millilitre Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: * Under 18 years * Severe concomitant disease * High risk for infections * previous vaccination for pneumococci and hepatitis B

Design outcomes

Primary

Measure	Time frame
Main Objective: * Analysing the mechanisms explaining the more pronounced induction of antinuclear antibodies after infliximab than etanercept. * 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	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026