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 - 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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43571

Enrollment

100

Registered

2014-12-15

Start date

2015-02-17

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

psoriasis reumatic disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Phase 1: - 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).

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 (=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).

Design outcomes

Primary

Measure	Time frame
Phase 1: Amongst patients that perceive inefficacy of their first TNF inhibitor, the percentage of patients that test positive for anti-drug antibodies, detectable with a radioimmunoassay. Phase 2: Efficacy: - RA: minimal disease activity (DAS28 1.3) - PsA: minimal disease activity - Pso: PASI 75 MDA is defined as a score of at least 5 out of 7 from the following outcome measures: TJC (0-68) 1, SJC (0-66) 1, PASI 3, patient pain VAS 15 (scale 0-100), patient global disease activity VAS 15 (scale 0-100); HAQ score 0.5, and tender entheseal points *1(using Leeds Enthesitis Index, LEI). Immunogenicity: the percentage of patients that test positive for anti-drug antibodies, detectable with a radioimmunoassay	—

Measure

Time frame

Phase 1: Amongst patients that perceive inefficacy of their first TNF inhibitor, the percentage of patients that test positive for anti-drug antibodies, detectable with a radioimmunoassay. Phase 2: Efficacy: - RA: minimal disease activity (DAS28 1.3) - PsA: minimal disease activity** - Pso: PASI 75 **MDA is defined as a score of at least 5 out of 7 from the following outcome measures: TJC (0-68) *1, SJC (0-66) *1, PASI *3, patient pain VAS *15 (scale 0-100), patient global disease activity VAS *15 (scale 0-100); HAQ score *0.5, and tender entheseal points *1(using Leeds Enthesitis Index, LEI). Immunogenicity: the percentage of patients that test positive for anti-drug antibodies, detectable with a radioimmunoassay

—

Secondary

Measure	Time frame
Phase 2: Efficacy: - RA: SDAI remission. Effect on HaQ. - AS: ASDAS, minimal disease activity (	—

Countries

Netherlands

Outcome results