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

AbbVie224 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

224

Conditions

Ankylosing Spondylitis (AS)Psoriasis Rheumatoid Arthritis (RA)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (10)

Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340

Shenzhen, Guangdong, China

AbbVie China /ID# 164373

Shanghai, Shanghai Municipality, China

The First affiliated hospital of chengdu medical university /ID# 210745

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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.

Time frame: From Week 0 to Week 24

Secondary Outcomes

Assessing drug persistence

This is measured using drug survival rate.

Time frame: Up to Week 52

Change from baseline in Healthcare Resource Utilization (HCRU)

This is assessed using the HCRU questionnaire.

Time frame: From Week 0 to Week 52

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.

Time frame: Up to Week 52

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.

Time frame: Up to Week 52

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.

Time frame: Up to Week 52

Data from ClinicalTrials.gov

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