Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases

Psoriasis Clinical Trial

— ADMIT  

Official title:

Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339089
• Other study ID #: P16-828
• Status: Completed
• Start date: May 18, 2018
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis (AS)
• Arthritis
• Arthritis, Rheumatoid
• Psoriasis
• Rheumatoid Arthritis (RA)
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
China	Sichuan Provincial orthopedic hospital /ID# 209341	Chengdu
China	The First affiliated hospital of chengdu medical university /ID# 210745	Chengdu	Sichuan
China	West China Hospital, SCU West China School of Medicine, SCU /ID# 209333	Chengdu
China	Sir Run Run Shaw Hospital /ID# 210820	Hangzhou	Zhejiang
China	Zhejiang Province People's Hospital /ID# 209342	Hangzhou	Zhejiang
China	The First Hospital of Jiaxing /ID# 213686	Jiaxing	Zhejiang
China	The Second Hospital of Jiaxing /ID# 210744	Jiaxing	Zhejiang
China	Jinhua Municipal Central Hospital /ID# 209339	Jinhua	Zhejiang
China	AbbVie China /ID# 164373	Shanghai	Shanghai
China	Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24	The European quality of life-5 dimensions (EQ-5D) is a simple, easy to administer, standardized and self-report instrument for health status, which is applicable to a wide range of health conditions and treatment.	From Week 0 to Week 24
Secondary	Assessing drug persistence	This is measured using drug survival rate.	Up to Week 52
Secondary	Change from baseline in Healthcare Resource Utilization (HCRU)	This is assessed using the HCRU questionnaire.	From Week 0 to Week 52
Secondary	Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Ankylosing spondylitis (AS)	WPAI questionnaire will be used to measure work absenteeism, work presenteeism, and daily activity impairment.	Up to Week 52
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI) in participants with Psoriasis (Ps)	The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool in psoriasis clinical research.	Up to Week 52
Secondary	Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Rheumatoid Arthritis (RA)	WPAI questionnaire will be used to measure work absenteeism, work presenteeism, and daily activity impairment.	Up to Week 52
Secondary	Change from baseline in Clinical Disease Activity Index (CDAI) in participants with Rheumatoid Arthritis (RA)	The CDAI is used to evaluate disease activity.	Up to Week 52
Secondary	Percentage of participants achieving low disease activity (CDAI 2.8-10) in participants with Rheumatoid Arthritis (RA)	The CDAI is used to evaluate disease activity.	Up to Week 52
Secondary	Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with Ankylosing spondylitis (AS)	BASDAI score is determined using a simple, self-reported questionnaire.	Up to Week 52
Secondary	Percentage of participants achieving remission (CDAI<=2.8) in participants with Rheumatoid Arthritis (RA)	The CDAI is used to evaluate disease activity.	Up to Week 52
Secondary	Change from baseline in EQ-5D Visual analog scale (VAS)	It is a patient-reported outcome (PRO) questionnaires used to assess quality of life (QoL).	From Week 0 to Week 52
Secondary	Change from baseline in EQ-5D index score up to Week 52	The European quality of life-5 dimensions (EQ-5D) is a simple, easy to administer, standardized and self-report instrument for health status, which is applicable to a wide range of health conditions and treatment.	From Week 0 to Week 52
Secondary	Proportion of participants achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in participants with Ankylosing spondylitis (AS)	BASDAI score is determined using a simple, self-reported questionnaire.	Up to Week 52
Secondary	Change from baseline in Psoriasis Area and Severity Index (PASI) in participants with Psoriasis (Ps)	PASI provides a quantitative assessment of psoriasis disease state.	Up to Week 52

External Links

•   clinical study report synopsis