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Dose decrease of biologics in psoriasis patients with low disease activity.


- candidate number22460
- NTR NumberNTR5301
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2015
- Secondary IDs80-83600-98-40024 ZonMw project
- Public TitleDose decrease of biologics in psoriasis patients with low disease activity.
- Scientific TitleTight control dose reductions of biologics in psoriasis patients with low disease activity: a randomized pragmatic trial.
- ACRONYM
- hypothesisDosages 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) studiedPsoriasis, 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2016
- planned closingdate10-jan-2019
- Target number of participants120
- InterventionsLowering frequency of biologic given
- Primary outcomePsoriasis Area and Severity Index (PASI) at 12 months
- Secondary outcomeDermatology 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
- Timepoints0-3-6-9-12 months
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIES JMPA van den Reek
- CONTACT for SCIENTIFIC QUERIES JMPA van den Reek
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications-
- Brief summaryModerate 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)
- RECORD15-jul-2015 - 20-aug-2015


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