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

Psoriasis Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236870
• Other study ID #: P15-986
• Status: Completed
• Start date: September 8, 2017
• Est. completion date: August 25, 2020

Study information

• Verified date: October 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: August 25, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
China	Peking University 3rd Hospital /ID# 213443	Beijing
China	Dermatology Hospital of southe /ID# 169830	Guangzhou
China	Guangzhou 1st Muni People Hosp /ID# 208858	Guangzhou	Guangdong
China	2nd Aff. Hosp Harbin Med Univ /ID# 169827	Haerbin
China	The Second Affiliated Hospital /ID# 169842	Hangzhou	Zhejiang
China	The First Affiliated Hospital /ID# 171398	Hefei	Anhui
China	Sir Run Run Shaw Hospital /ID# 169834	Jianggan Hangzhou	Zhejiang
China	Shandong Provincial Hospital /ID# 169841	Jinan
China	Ruijin Hospital, Shanghai Jiaotong /ID# 169833	Shanghai	Shanghai
China	The Tenth People's Hospital of /ID# 169831	Shanghai
China	The First Affiliated Hospital of Shantou University Medical College /ID# 209260	Shantou
China	The 7th People's Hospital of Shenyang /ID# 169829	Shenyang
China	Shenzhen Hospital of Southern /ID# 169828	Shenzhen
China	Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201	Tianjin
China	Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183	Wulumuqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score	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.	At Week 12
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI)	The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.	From Week 0 to Week 12

External Links

•   clinical study report synopsis