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Completed

NCT Number: NCT03236870

A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China

The objective of this non-interventional, observational study is to assess the effectiveness and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in real world clinical practice in China.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital /ID# 171398, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant who is in compliance with eligibility for adalimumab based on the local label;
  • Moderate to severe plaque psoriasis patients eligible to use adalimumab according to the local label without any contraindication
  • Patients have signed the authorization (or informed consent where applicable) to disclose and use personal health information after been prescribed with adalimumab.

Exclusion criteria

  • Patients who are pregnant or breast feeding at enrolment or wish to become pregnant during the following adalimumab treatment and within 150 days since adalimumab discontinuation;
  • Patients in any psoriasis related clinical trial at the time of enrolment, at baseline or at any point during the study follow-up;
  • Patients with active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) as well as moderate to severe cardiac insufficiency.
  • Patients with difficulties for adequately reading, understanding and completing patient questionnaires.

Treatment and study plan

Primary outcomes

  1. Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score

    Time frame: At Week 12

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.

Secondary outcomes

  1. Change from Baseline in Dermatology Life Quality Index (DLQI)

    Time frame: From Week 0 to Week 12

    The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Postmarketing Observational Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China

Acronym: ADAPT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2017
Registry last updated
Oct 14, 2021

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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