A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- 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.
- 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.
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)
The First Affiliated Hospital /ID# 171398
🇨🇳Hefei, Anhui, China
Guangzhou 1st Muni People Hosp /ID# 208858
🇨🇳Guangzhou, Guangdong, China
Ruijin Hospital, Shanghai Jiaotong /ID# 169833
🇨🇳Shanghai, Shanghai, China
Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183
🇨🇳Wulumuqi, Xinjiang, 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
Dermatology Hospital of southe /ID# 169830
🇨🇳Guangzhou, China
2nd Aff. Hosp Harbin Med Univ /ID# 169827
🇨🇳Haerbin, China
Shandong Provincial Hospital /ID# 169841
🇨🇳Jinan, China
Scroll for more (5 remaining)The First Affiliated Hospital /ID# 171398🇨🇳Hefei, Anhui, China