The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit

• Conditions: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-002284-42-FI
• Lead Sponsor: READE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-28
• Last Update Posted: 28 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1650

Inclusion Criteria

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

Exclusion criteria phase 1:
• 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified