Clinical trial NCT03236870: A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: psoriasis
effectiveness
safety
adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-08-02
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with moderate to severe plaque psoriasis in China

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score
timeFrame: At Week 12
Secondary outcomes:
measure: Change from Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: From Week 0 to Week 12
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital /ID# 171398
state: Anhui
city: Guangzhou
country: China
facility: Guangzhou 1st Muni People Hosp /ID# 208858
state: Guangdong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong /ID# 169833
state: Shanghai
city: Wulumuqi
country: China
facility: Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183
state: Xinjiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital /ID# 169842
state: Zhejiang
city: Jianggan Hangzhou
country: China
facility: Sir Run Run Shaw Hospital /ID# 169834
state: Zhejiang
city: Beijing
country: China
facility: Peking University 3rd Hospital /ID# 213443
city: Guangzhou
country: China
facility: Dermatology Hospital of southe /ID# 169830
city: Haerbin
country: China
facility: 2nd Aff. Hosp Harbin Med Univ /ID# 169827
city: Jinan
country: China
facility: Shandong Provincial Hospital /ID# 169841
city: Shanghai
country: China
facility: The Tenth People's Hospital of /ID# 169831
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College /ID# 209260
city: Shenyang
country: China
facility: The 7th People's Hospital of Shenyang /ID# 169829
city: Shenzhen
country: China
facility: Shenzhen Hospital of Southern /ID# 169828
city: Tianjin
country: China
facility: Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: