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

Study Overview
=================
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.

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

Conditions
-----------------
Ankylosing Spondylitis (AS), Psoriasis, Rheumatoid Arthritis (RA)

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Rheumatoid Arthritis (RA)<br>This group/ cohort includes participants with RA. | |
| Participants with Plaque Psoriasis (Ps)<br>This group/ cohort includes participants with Ps. | |
| Participants with Ankylosing spondylitis (AS)<br>This group/ cohort includes participants with AS. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing drug persistence | This is measured using drug survival rate. | Up to Week 52 | 
| Change from baseline in Healthcare Resource Utilization (HCRU) | This is assessed using the HCRU questionnaire. | 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. | 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. | 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. | Up to Week 52 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, Immune-Mediated Inflammatory Diseases, Chinese Patients