No registrations found.
ID
Source
Health condition
psoriasis, biologics, tnf-alfa remmers, etanercept, adalimumab, ustekinumab, dosis reductie, dose reduction, dose decrease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psoriasis Area and Severity Index (PASI) at 12 months
Secondary outcome
Dermatology Life Quality Index (DLQI) at 12 months
PASI scores at each time point
Time until flare
Trough level antidrug antibodies and serum drug levels at each time point
hsCRP at each time point
SAEs
Background summary
Moderate to severe psoriasis can be treated succesfully with biologics. However, we do not know what the lowest possible dose is in individual patients that have a stable low disease activity. We propose to lower the dose with tight control of disease activity (PASI score) and dermatology-related quality of life (DLQI) in order to improve safety and cost-effectivenes.
Study objective
Dosages can be lowered succesfully in patients with a stable low disease activity and quality of life. This improves safety and cost-effectiveness.
Study design
0-3-6-9-12 months
Intervention
Lowering frequency of biologic given
Inclusion criteria
(1) Treatment of at least 6 months with one biologic
(2) During the last 6 months, subsequent low disease activity scores (PASI (psoriasis area and severity index) <5) until the moment of inclusion. At least 2 PASI scores should be available.
(3) Good disease-related quality of life (DLQI (dermatology life quality index) ≤5) at the moment of inclusion in the study
• Established diagnosis of plaque psoriasis.
• Receiving treatment with adalimumab, etanercept, or ustekinumab.
• 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.
• Infliximab use
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5161 |
| NTR-old | NTR5301 |
| Other | ZonMw project : 80-83600-98-40024 |