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)
Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183
๐จ๐ณWulumuqi, Xinjiang, China
The 7th People's Hospital of Shenyang /ID# 169829
๐จ๐ณShenyang, China
The Second Affiliated Hospital /ID# 169842
๐จ๐ณHangzhou, Zhejiang, China
Sir Run Run Shaw Hospital /ID# 169834
๐จ๐ณJianggan Hangzhou, Zhejiang, China
Peking University 3rd Hospital /ID# 213443
๐จ๐ณBeijing, China
Shandong Provincial Hospital /ID# 169841
๐จ๐ณJinan, China
The Tenth People's Hospital of /ID# 169831
๐จ๐ณShanghai, China
The First Affiliated Hospital of Shantou University Medical College /ID# 209260
๐จ๐ณShantou, China
Shenzhen Hospital of Southern /ID# 169828
๐จ๐ณShenzhen, China
Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201
๐จ๐ณTianjin, China
Ruijin Hospital, Shanghai Jiaotong /ID# 169833
๐จ๐ณShanghai, Shanghai, China
Guangzhou 1st Muni People Hosp /ID# 208858
๐จ๐ณGuangzhou, Guangdong, China
The First Affiliated Hospital /ID# 171398
๐จ๐ณHefei, Anhui, China
2nd Aff. Hosp Harbin Med Univ /ID# 169827
๐จ๐ณHaerbin, China
Dermatology Hospital of southe /ID# 169830
๐จ๐ณGuangzhou, China