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Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients

NCT ID: NCT02147600

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-09

Study Completion Date

2014-04-10

Brief Summary

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The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response. Determination of these values is necessary to compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary objective of this study is to further detect and quantify AAA and to correlate them with adalimumab and clinical response in a real life setting cohort of psoriatic patients.

Detailed Description

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In a multicenter cross-sectional study, 73 adult patients treated with adalimumab (40 mg) every other week for at least 24 weeks are assessed for psoriasis disease severity through measurement of the Psoriasis Area and Severity Index (PASI) before adalimumab treatment start, and prior to sampling. Patients who interrupted their treatment schedule during the 24 weeks prior to blood sampling are excluded. Samples of patients who were treated with adalimumab for any other inflammatory disease and later developed psoriasis are also excluded. Percentage of PASI improvement compared to baseline (∆PASI) represents clinical response. Patients are classified as nonresponders (∆PASI\<50), moderate responders (∆PASI 50-75) or good responders (∆PASI 75-100).Serum is collected for adalimumab trough level and anti-drug antibody determination (Sanquin, The Netherlands). By receiver-operator characteristics (ROC) analysis, a cut-off value of adalimumab trough level can be determined to distinguish insufficient from adequate responders.

Conditions

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Psoriasis

Keywords

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adalimumab biologicals immunogenicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic plaque psoriasis

Patients suffering from chronic plaque psoriasis, treated with adalimumab (40mg) subcutaneously every other week after an initial dose of 80 mg. Treatment duration of at least 24 weeks.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* minimum age 18 years old
* chronic plaque psoriasis
* adalimumab (40mg) subcutaneously every other week
* at least 24 weeks of adalimumab treatment

Exclusion Criteria

* interruption of treatment schedule during 24 weeks prior to sampling
* adalimumab for other inflammatory disease and later developed psoriasis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jo Lambert, Prof.Dr.

Role: STUDY_DIRECTOR

Ghent University, Dpt. of Dermatology

Emma Coussens

Role: PRINCIPAL_INVESTIGATOR

Ghent University, Dpt. of Dermatology

Locations

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Ghent University, Dpt. of Dermatology

Ghent, , Belgium

Site Status

Maria Middelares Hospital

Ghent, , Belgium

Site Status

St. Lucas Hospital

Ghent, , Belgium

Site Status

H Hart Hospital

Mol, , Belgium

Site Status

ST Rembert Hospital

Torhout, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EC UZG 2013/1148

Identifier Type: -

Identifier Source: org_study_id