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Completed

NCT Number: NCT02147600

Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University, Dpt. of Dermatology, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. anti-adalimumab antibody formation

    Time frame: at least 24 weeks of treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 28, 2014
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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