INTENT: immunogenicity in patients failing response on anti-TNF - phase 1: immunogenicity and pharmacokinetics in patients failing to respond to TNF inhibitors. - phase 2: clinical effectiveness of subsequent TNF inhibitor treatment and predictive value of pharmacokinetics and immunogenicity. - INTENT: immunogenicity in patients failing response on anti-TNF

Jan van Breemen Instituut0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) or psoriasis (Pso) treated with a first TNF inhibitor (adalimumab, infliximab, etanercept, golimumab or certolizumab pegol) in daily clinical practice across different European countries.
•- TNF inhibitor treatment has been initiated and continued until failure at dose and interval according to label (adalimumab 40 mg every other week (eow); etanercept 50 mg once weekly or 25 mg twice weekly; golimumab 50 mg once monthly; certolizumab pegol 200 mg eow; infliximab 3 mg/kg per 8 weeks (RA), infliximab 5 mg/kg per 6-8 weeks (AS), infliximab 5 mg/kg per 8 weeks (PsA or Pso).
•- Inefficacy of first TNF inhibitor (both 'primary' and 'secondary' failure) resulting in switch of therapy.
•- planned treatment with a second TNF inhibitor.
•- written informed consent.;Phase 2:
•- participation in phase 1.
•- first TNF inhibitor treatment is switched to second TNF inhibitor treatment (at labeled dose).

•- current TNF inhibitor treatment is not the first TNF inhibitor ever used for this patient.
•- first TNF inhibitor treatment switched due to other reasons than inefficacy (e.g. side effects).
•- serum sample not taken at trough (=prior to the next infusion/injection with the TNF inhibitor for patients on drug).;Phase 2:
•- treatment is switched to other treatment than TNF inhibitor.
•- serum sample not taken at trough (prior to the next infusion/injection with the TNF inhibitor).

发起方

Jan van Breemen Instituut