A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
ADAPT
Postmarketing Observational Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
1 other identifier
observational
181
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedStudy Start
First participant enrolled
September 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2020
CompletedOctober 14, 2021
October 1, 2021
3 years
July 31, 2017
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change from Baseline in Dermatology Life Quality Index (DLQI)
From Week 0 to Week 12
Study Arms (1)
Participants with moderate to severe plaque psoriasis in China
Participants with moderate to severe plaque psoriasis in China receiving adalimumab in daily clinical practice.
Eligibility Criteria
Adult patients with moderate to severe plaque psoriasis in China
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (15)
The First Affiliated Hospital /ID# 171398
Hefei, Anhui, 230031, China
Guangzhou 1st Muni People Hosp /ID# 208858
Guangzhou, Guangdong, 510030, China
Ruijin Hospital, Shanghai Jiaotong /ID# 169833
Shanghai, Shanghai Municipality, 200025, China
Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183
Ürümqi, Xinjiang, 830099, China
The Second Affiliated Hospital /ID# 169842
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital /ID# 169834
Jianggan Hangzhou, Zhejiang, 310018, China
Peking University 3rd Hospital /ID# 213443
Beijing, 100191, China
Dermatology Hospital of southe /ID# 169830
Guangzhou, 510018, China
2nd Aff. Hosp Harbin Med Univ /ID# 169827
Haerbin, 150086, China
Shandong Provincial Hospital /ID# 169841
Jinan, 250021, China
The Tenth People's Hospital of /ID# 169831
Shanghai, 200072, China
The First Affiliated Hospital of Shantou University Medical College /ID# 209260
Shantou, 515000, China
The 7th People's Hospital of Shenyang /ID# 169829
Shenyang, 110003, China
Shenzhen Hospital of Southern /ID# 169828
Shenzhen, 518110, China
Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201
Tianjin, 300381, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 2, 2017
Study Start
September 8, 2017
Primary Completion
August 25, 2020
Study Completion
August 25, 2020
Last Updated
October 14, 2021
Record last verified: 2021-10