Ankylosing Spondylitis (AS), Psoriasis, Rheumatoid Arthritis (RA)
Conditions
Keywords
rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, Immune-Mediated Inflammatory Diseases, Chinese Patients
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 Clinical Disease Activity Index (CDAI) 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. |
| Assessing drug persistence | Up to Week 52 | This is measured using drug survival rate. |
| 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. |
| 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 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. |
| 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 Psoriasis Area and Severity Index (PASI) in participants with Psoriasis (Ps) | Up to Week 52 | PASI provides a quantitative assessment of psoriasis disease state. |
| 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. |
Countries
China
Outcome results
None listed