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

Completed

• Conditions: Psoriasis; Ankylosing Spondylitis (AS); Rheumatoid Arthritis (RA)

• Registration Number: NCT03339089
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2018-05-18
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24	From Week 0 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.

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Sir Run Run Shaw Hospital /ID# 210820; 🇨🇳 Hangzhou, Zhejiang, China

The Second Hospital of Jiaxing /ID# 210744; 🇨🇳 Jiaxing, Zhejiang, China

Sichuan Provincial orthopedic hospital /ID# 209341; 🇨🇳 Chengdu, China

West China Hospital, SCU West China School of Medicine, SCU /ID# 209333; 🇨🇳 Chengdu, China

AbbVie China /ID# 164373; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Province People's Hospital /ID# 209342; 🇨🇳 Hangzhou, Zhejiang, China

The First Hospital of Jiaxing /ID# 213686; 🇨🇳 Jiaxing, Zhejiang, China

Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340; 🇨🇳 Shenzhen, Guangdong, China

The First affiliated hospital of chengdu medical university /ID# 210745; 🇨🇳 Chengdu, Sichuan, China

Jinhua Municipal Central Hospital /ID# 209339; 🇨🇳 Jinhua, Zhejiang, China