INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT

READE0 个研究点目标入组 1,650 人开始时间: 2015年8月28日最近更新: 2015年9月28日

试验速览

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•Inclusion criteria phase 1:
•Patients with RA, PsA, AS or 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*
•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;
•*adalimumab 40 mg every other week; etanercept 50 mg once weekly or 25 mg twice
•weekly; golimumab 50 mg once monthly, certolizumab 200 mg every other week;
•infliximab 3 mg/kg / 8 weeks (RA); infliximab 5 mg/kg / 6-8 weeks (AS); infliximab 5
•mg/kg / 8 weeks (PsA or Pso);
•Inclusion criteria phase 2:
•Participation in phase 1;
•First TNF inhibitor treatment is switched to second TNF inhibitor treatment (at
•labelled dose)
•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 1550
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Exclusion criteria phase 1:
•Current TNF inhibitor treatment is not the first TNF inhibitor ever used for this
•First TNF inhibitor treatment switched due to other reasons than inefficacy (e.g.
•side effects)
•Serum sample not taken at trough
•Exclusion criteria phase 2:
•Treatment is switched to other treatment than TNF inhibitor
•Serum sample not taken at trough (for definition see ‘trough sample definitions

发起方

READE