Dose decrease of biologics for psoriasis

Phase 1

• Conditions: Adult Patients diagnosed psoriasis vulgaris; MedDRA version: 18.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.1Level: LLTClassification code 10015581Term: Exacerbation of psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.1Level: LLTClassification code 10037155Term: Psoriasis and similar disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.1Level: LLTClassification code 10037156Term: Psoriasis flare-upSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-000943-17-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-15
• Study Completion: 2019-08-01
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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.
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

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

Primary Outcome Measures

Name	Time	Method
Main Objective: We aim to investigate whether we could taper the biologics dose in psoriasis patietns with stable disease-activity and good quality of life. The primary research question for this proposal is: Is a biologics dose tapering strategy non-inferior to usual care with respect to disease activity?;Secondary Objective: Secondary questions are: Is quality of life (DLQI) maintained during dose tapering? Are there factors that predict successful dose tapering? How cost-effective is dose tapering in this group? How does dose-tapering change the safety profile regarding side-effects or antibody formation? ;Primary end point(s): PASI at month 12. ;Timepoint(s) of evaluation of this end point: baseline<br>month 3<br>month 6<br>month 9<br>month 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •DLQI (Dermatology Life Quality Index) at 12 months.<br>•Disease-activity scores (PASI) at each time point (month 3/6/9/12) <br>•Time until flare for the dose <br>•Correlation between marker of disease activity (high-sensitivity CRP) and 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 point <br><br>•Predictors related to succes of intervention(baseline patient and treatment characteristics, HLA-C*06, baseline trough drug concentration and anti-drug antibodies, high-sensitivity CRP) <br>;Timepoint(s) of evaluation of this end point: baseline<br>month 3<br>month 6<br>month 9<br>month 12