Tight control dose reductions of biologics in psoriasis patients with low disease activity: a randomized pragmatic trial.

Phase 4

Completed

Conditions: psoriasis
10014982

Registration Number: NL-OMON42814

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

* Sustained low disease activity (PASI<5 for at least 6 months, DLQI<5 at inclusion) on the regular dose as advised by the label.;* Established diagnosis of plaque psoriasis.;* Receiving treatment with adalimumab, etanercept, or ustekinumab for at least 6 months.;* Age *18 years.

Exclusion Criteria

* Psoriasis itself is not the main reason for biologic prescription (e.g. when a patient has RA and psoriasis, and RA is the main reason for the biologic).;* Concomitant use of immunosupressants other than methotrexate or acitretin for psoriasis.;* Severe comorbidities with short life-expectancy (e.g. metastasized tumour).;* Presumed inability to follow the study protocol.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease-activity (Psoriasis Area and Severity Index (PASI)) at 12 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* DLQI (Dermatology Life Quality Index) at 12 months.<br /><br>* Disease-activity scores (PASI) at each time point (month 3/6/9/12)<br /><br>* Time until flare<br /><br>* Correlation between marker of disease activity (high-sensitivity CRP) and<br /><br>PASI at different time points<br /><br>* Number of SAEs<br /><br>* Extent of trough level antidrug antibodies and serum drug levels at each time<br /><br>point<br /><br>* Predictors related to succesfull dose-tapering (baseline patient and<br /><br>treatment characteristics, HLA-C*06, baseline trough drug concentration and<br /><br>anti-drug antibodies, high-sensitivity CRP) </p><br>