Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients

December 22, 2022 updated by: University Hospital, Ghent
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University, Dpt. of Dermatology
      • Ghent, Belgium, 9000
        • Maria Middelares Hospital
      • Ghent, Belgium, 9000
        • St. Lucas Hospital
      • Mol, Belgium, 2400
        • H Hart Hospital
      • Torhout, Belgium, 8820
        • ST Rembert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Primary care clinic
  • University Hospital
  • Private dermatology practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
75% improvement in clinical response
Time Frame: at least 24 weeks of treatment duration
Minimum of 75 % PASI improvement compared to baseline (∆PASI 75) represents 75% improvement in clinical response.
at least 24 weeks of treatment duration

Secondary Outcome Measures

Outcome Measure
Time Frame
anti-adalimumab antibody formation
Time Frame: at least 24 weeks of treatment
at least 24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Study Director: Jo Lambert, Prof.Dr., Ghent University, Dpt. of Dermatology
  • Principal Investigator: Emma Coussens, Ghent University, Dpt. of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2014

Primary Completion (Actual)

April 10, 2014

Study Completion (Actual)

April 10, 2014

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC UZG 2013/1148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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