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

Tight control dose reductions of biologics in psoriasis patients with low disease activity: a randomized pragmatic trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24722
Enrollment
120
Registered
2015-07-15
Start date
2016-01-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis, biologics, tnf-alfa remmers, etanercept, adalimumab, ustekinumab, dosis reductie, dose reduction, dose decrease

Interventions

Lowering frequency of biologic given

Sponsors

Radboudumc, Nijmegen, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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) &#8804;5) at the moment of inclusion in the study • Established diagnosis of plaque psoriasis. • Receiving treatment with adalimumab, etanercept, or ustekinumab. • Age &#8805;18 years.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Psoriasis Area and Severity Index (PASI) at 12 months

Secondary

MeasureTime frame
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

Contacts

Public ContactJMPA van den Reek
onderzoek@derma.umcn.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)