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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03236870

Acronym

ADAPT

Enrollment

181

Registered

2017-08-02

Start date

2017-09-08

Completion date

2020-08-25

Last updated

2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

psoriasis, effectiveness, safety, adalimumab

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score	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

Measure	Time frame	Description
Change from Baseline in Dermatology Life Quality Index (DLQI)	From Week 0 to Week 12	The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.

Countries

China

Outcome results