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

AbbVie15 sites in 1 country181 target enrollmentSeptember 8, 2017

ConditionsPsoriasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Psoriasis
Sponsor: AbbVie
Enrollment: 181
Locations: 15
Primary Endpoint: Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 8, 2017

End Date

August 25, 2020

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.