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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42814

Enrollment

120

Registered

2015-12-09

Start date

2016-03-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

psoriasis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Sustained low disease activity (PASI

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.

Design outcomes

Primary

Measure	Time frame
Disease-activity (Psoriasis Area and Severity Index (PASI)) at 12 months.	—

Secondary

Measure	Time frame
* 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)	—

Measure

Time frame

* 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)

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Countries

Netherlands

Outcome results