Clinical trial NCT03339089: Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases
Official title: Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis (AS)
Psoriasis
Rheumatoid Arthritis (RA)
Keywords: rheumatoid arthritis
plaque psoriasis
ankylosing spondylitis
Immune-Mediated Inflammatory Diseases
Chinese Patients
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 224
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: Chinese participants diagnosed with rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis, for whom adalimumab (Humira®) treatment has already been decided as per local label, will be recruited from within the clinical setting of each rheumatologist or dermatologist participating in the study.

Brief summary: The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Participants with a diagnosis of rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis
* Decision to initiate Humira® treatment in accordance with routine medical practice and in compliance with eligibility for adalimumab based on the local label
* Prior to any study-specific procedures, participant has voluntarily signed the authorization (or informed consent where applicable) to disclose and use anonymized personal health information after participate in this research.

Exclusion Criteria:

* Inadequate response to previous standard treatment with anti-tumor necrosis factor (TNF) biological agent according to the physician's clinical judgment.
* Participant has been treated with adalimumab within 70 days (five half-lives) prior to the Baseline Visit.
* Participants discontinued due to adverse drug reaction of previous adalimumab treatment.
* Participants who fulfill any of the contraindications as per adalimumab label in China.
* Participants, who in the clinician's view, may not be able to comply with the study requirements.

Primary outcomes:
measure: Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24
timeFrame: From Week 0 to Week 24
Secondary outcomes:
measure: Assessing drug persistence
timeFrame: Up to Week 52
measure: Change from baseline in Healthcare Resource Utilization (HCRU)
timeFrame: From Week 0 to Week 52
measure: Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Ankylosing spondylitis (AS)
timeFrame: Up to Week 52
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) in participants with Psoriasis (Ps)
timeFrame: Up to Week 52
measure: Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Rheumatoid Arthritis (RA)
timeFrame: Up to Week 52
measure: Change from baseline in Clinical Disease Activity Index (CDAI) in participants with Rheumatoid Arthritis (RA)
timeFrame: Up to Week 52
measure: Percentage of participants achieving low disease activity (CDAI 2.8-10) in participants with Rheumatoid Arthritis (RA)
timeFrame: Up to Week 52
measure: Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with Ankylosing spondylitis (AS)
timeFrame: Up to Week 52
measure: Percentage of participants achieving remission (CDAI<=2.8) in participants with Rheumatoid Arthritis (RA)
timeFrame: Up to Week 52
measure: Change from baseline in EQ-5D Visual analog scale (VAS)
timeFrame: From Week 0 to Week 52
measure: Change from baseline in EQ-5D index score up to Week 52
timeFrame: From Week 0 to Week 52
measure: Proportion of participants achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in participants with Ankylosing spondylitis (AS)
timeFrame: Up to Week 52
measure: Change from baseline in Psoriasis Area and Severity Index (PASI) in participants with Psoriasis (Ps)
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340
state: Guangdong
city: Shanghai
country: China
facility: AbbVie China /ID# 164373
state: Shanghai
city: Chengdu
country: China
facility: The First affiliated hospital of chengdu medical university /ID# 210745
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Province People's Hospital /ID# 209342
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital /ID# 210820
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing /ID# 213686
state: Zhejiang
city: Jiaxing
country: China
facility: The Second Hospital of Jiaxing /ID# 210744
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital /ID# 209339
state: Zhejiang
city: Chengdu
country: China
facility: Sichuan Provincial orthopedic hospital /ID# 209341
city: Chengdu
country: China
facility: West China Hospital, SCU West China School of Medicine, SCU /ID# 209333
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: