|- candidate number||22460|
|- NTR Number||NTR5301|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-jul-2015|
|- Secondary IDs||80-83600-98-40024 ZonMw project |
|- Public Title||Dose decrease of biologics in psoriasis patients with low disease activity.|
|- Scientific Title||Tight control dose reductions of biologics in psoriasis patients with low disease activity: a randomized pragmatic trial.|
|- hypothesis||Dosages can be lowered succesfully in patients with a stable low disease activity and quality of life. This improves safety and cost-effectiveness.|
|- Healt Condition(s) or Problem(s) studied||Psoriasis, Biological, TNF-alpha, Dose effects|
|- 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
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-jan-2016|
|- planned closingdate||10-jan-2019|
|- Target number of participants||120|
|- Interventions||Lowering frequency of biologic given|
|- 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
|- Timepoints||0-3-6-9-12 months|
|- Trial web site||-|
|- CONTACT FOR PUBLIC QUERIES|| JMPA van den Reek|
|- CONTACT for SCIENTIFIC QUERIES|| JMPA van den Reek|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||15-jul-2015 - 20-aug-2015|