Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients

Psoriasis Clinical Trial

Official title:

Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147600
• Other study ID #: EC UZG 2013/1148
• Status: Completed
• Start date: January 9, 2014
• Est. completion date: April 10, 2014

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 10, 2014
• Est. primary completion date: April 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Belgium	Ghent University, Dpt. of Dermatology	Ghent
Belgium	Maria Middelares Hospital	Ghent
Belgium	St. Lucas Hospital	Ghent
Belgium	H Hart Hospital	Mol
Belgium	ST Rembert Hospital	Torhout

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	75% improvement in clinical response	Minimum of 75 % PASI improvement compared to baseline (?PASI 75) represents 75% improvement in clinical response.	at least 24 weeks of treatment duration
Secondary	anti-adalimumab antibody formation		at least 24 weeks of treatment