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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Rheumatoid Arthritis (RA) | This group/ cohort includes participants with RA. | ||
| Participants with Plaque Psoriasis (Ps) | This group/ cohort includes participants with Ps. | ||
| Participants with Ankylosing spondylitis (AS) | This group/ cohort includes participants with AS. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese participants diagnosed with rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis, for whom adalimumab (Humira®) treatment has already been decided as per local label, will be recruited from within the clinical setting of each rheumatologist or dermatologist participating in the study.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340 | Shenzhen | Guangdong | 518040 | China | ||
| AbbVie China /ID# 164373 |
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| 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 |
| Shanghai |
| Shanghai Municipality |
| 200041 |
| China |
| The First affiliated hospital of chengdu medical university /ID# 210745 | Chengdu | Sichuan | 610500 | China |
| Zhejiang Province People's Hospital /ID# 209342 | Hangzhou | Zhejiang | 310014 | China |
| Sir Run Run Shaw Hospital /ID# 210820 | Hangzhou | Zhejiang | 310018 | China |
| The First Hospital of Jiaxing /ID# 213686 | Jiaxing | Zhejiang | 314000 | China |
| The Second Hospital of Jiaxing /ID# 210744 | Jiaxing | Zhejiang | 314033 | China |
| Jinhua Municipal Central Hospital /ID# 209339 | Jinhua | Zhejiang | 321000 | China |
| Sichuan Provincial orthopedic hospital /ID# 209341 | Chengdu | 610041 | China |
| West China Hospital, SCU West China School of Medicine, SCU /ID# 209333 | Chengdu | 610041 | China |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D011565 | Psoriasis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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