To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease-activity (Psoriasis Area and Severity Index (PASI)) at 12 months.
Secondary outcome
* DLQI (Dermatology Life Quality Index) at 12 months.
* Disease-activity scores (PASI) at each time point (month 3/6/9/12)
* Time until flare
* Correlation between marker of disease activity (high-sensitivity CRP) and
PASI at different time points
* Number of SAEs
* Extent of trough level antidrug antibodies and serum drug levels at each time
point
* Predictors related to succesfull dose-tapering (baseline patient and
treatment characteristics, HLA-C*06, baseline trough drug concentration and
anti-drug antibodies, high-sensitivity CRP)
Background summary
Moderate-to-severe psoriasis can be treated with biologics. These drugs have
significantly improved the quality of life of psoriasis patients, but are very
expensive drugs that should be used as efficiently as possible. In addition,
the long-term safety profile can probably be improved if patients receive the
lowest effective dose.
Study objective
To investigate whether the dose of biologics can be reduced in patients with
psoriasis with stable disease: is dose reduction non-inferior to the current
practice regarding clinical effectiveness? Secondary aims are: to investigate
what influence dose tapering has on quality of life, whether there are
predictors for successful dose reduction, and to determine the
cost-effectiveness of dose reduction.
Study design
A pragmatic, multicentre, randomized, controlled, non-inferiority study with
cost-effectiveness analysis.
Study burden and risks
As it is a daily practice study, in general, no extra visits are needed except
for regular visits every three months. As the study duration is one year for an
individual patients, 5 visits will be study related and will be longer than
normal (aprox 45 minutes at baseline, and 20-30 minutes at subsequent visits).
DLQI and cost-effectiveness questionnaires (SF-36, iMTA medical consumption
questionnaire and productivity cost questionnaire) will be taken every study
related visit. Extra blood for this study will be drawn at regular blood taking
moments. One or two extra vials will be taken (genetic research,through
levels/antibody formation) depending on the moment. Physical examination
consists of a PASI disease activity score, which can be considered as daily
practice as it is often used. Risks of dose decrease are deemed to be small.
Exacerbation of psoriasis can be expected as well as antibody formation agains
the biologic. We assume a lower risk of adverse events related to the drug
itself due to the lower dose.
René Descartesdreef 1
Nijmegen 6525GL
NL
René Descartesdreef 1
Nijmegen 6525GL
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2015-000943-17-NL |
| CCMO | NL54557.091.15 |