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

Completed

• Conditions: Psoriasis

• Registration Number: NCT03236870
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-02
• Study Start: 2017-09-08
• Primary Completion: 2020-08-25
• Study Completion: 2020-08-25
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (15)

Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183; 🇨🇳 Wulumuqi, Xinjiang, China

The 7th People's Hospital of Shenyang /ID# 169829; 🇨🇳 Shenyang, China

The Second Affiliated Hospital /ID# 169842; 🇨🇳 Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital /ID# 169834; 🇨🇳 Jianggan Hangzhou, Zhejiang, China

Peking University 3rd Hospital /ID# 213443; 🇨🇳 Beijing, China

Shandong Provincial Hospital /ID# 169841; 🇨🇳 Jinan, China

The Tenth People's Hospital of /ID# 169831; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Shantou University Medical College /ID# 209260; 🇨🇳 Shantou, China

Shenzhen Hospital of Southern /ID# 169828; 🇨🇳 Shenzhen, China

Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201; 🇨🇳 Tianjin, China

Ruijin Hospital, Shanghai Jiaotong /ID# 169833; 🇨🇳 Shanghai, Shanghai, China

Guangzhou 1st Muni People Hosp /ID# 208858; 🇨🇳 Guangzhou, Guangdong, China

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

2nd Aff. Hosp Harbin Med Univ /ID# 169827; 🇨🇳 Haerbin, China

Dermatology Hospital of southe /ID# 169830; 🇨🇳 Guangzhou, China