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Completed

NCT Number: NCT00799877

Chronic Plaque Psoriasis (Ps) Registry

The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duplicate_University Hospital St. Polten /ID# 22842, Sankt Pölten, Lower Austria, Austria

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About this study

ESPRIT is a 10 year registry of patients taking HUMIRA® for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with HUMIRA®. No registry specific testing will be performed. Patients will be asked to provide data on their experiences with HUMIRA® approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • An adult patient (18 years of age or older) with chronic plaque psoriasis who has been prescribed HUMIRA® therapy according to the local product labeling and meets one of the following criteria:
  • New initiated (within 4 weeks of registry entry) on HUMIRA® therapy;
  • Initiated HUMIRA® therapy in the past and:
  • Has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy and the physician can provide source documentation of SAEs, AEs, of Special Interest, and dosing information since initiation of therapy.

OR

  • Is entering after participation in an AbbVie HUMIRA (adalimumab) sponsored study and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy after the completion of AbbVie sponsored study and physician can provide source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of commercial HUMIRA® (defined as a prescribed/non study drug).
  • Patient is willing to consent to data being collected and provided to AbbVie;
  • Patient is capable of and willing to give written informed consent and to comply with the requirements of the registry.

Exclusion criteria

  • Patient should not be enrolled if he/she cannot be treated in accordance with the local product label.

Treatment and study plan

Primary outcomes

  1. Incidence of Serious Adverse Events

    Time frame: Duration of study

    Incidence of Adverse Events is calculated upon all events that occur during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.

  2. Incidence of Adverse Events of Special Interest

    Time frame: Duration of study

    Incidence of Adverse Events is calculated upon all events that occur during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.

  3. Adverse Events that lead to permanent discontinuation of HUMIRA®

    Time frame: Duration of study

    Incidence of Adverse Events that lead to permanent discontinuation of HUMIRA® is calculated upon all events that lead to permanent discontinuation of HUMIRA® during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.

Secondary outcomes

  1. Health Care Utilization

    Time frame: Duration of study

  2. Work Productivity and Activity Impairment Questionnaire: Specific Health Problem

    Time frame: Duration of study

  3. Patient Global Assessment

    Time frame: Duration of study

  4. Patient Health Question-9

    Time frame: Duration of study

  5. Medical Outcomes Social Activities Scale

    Time frame: Duration of study

  6. Patient reported outcome - Dermatology Life Quality Index

    Time frame: Duration of study

  7. Census

    Time frame: Duration of study

  8. Psoriasis Impact and Experience

    Time frame: Duration of study

  9. Illness Cognition

    Time frame: Duration of study

  10. Insurance Status

    Time frame: Duration of study

  11. Rosenberg Self-Esteem Scale

    Time frame: Duration of study

  12. Physician's Global Assessment

    Time frame: Collected approximately every six months.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)

Important dates

Study start
2008
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2008
Registry last updated
Mar 15, 2024

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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