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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO148ART4002 | Other Identifier | Janssen Research & Development, LLC |
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The participants included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.
The participants included in this study will be drawn from the Ingenix Normative Health Informatics Database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse US health plan. This study will include cohorts of participants who have claims consistent with a diagnosis of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and who initiate golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments. Participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of golimumab for up to 8 years. A sample of enrolled health plan members without claims evidence of diagnosis or treatment of Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis will also be selected. The claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected outcomes. No study agents will be administered in this study. All participants will receive standard-of-care treatment as prescribed by their physician
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | golimumab as prescribed |
| |
| 002 | anti-TNF biologics as prescribed |
| |
| 003 | non-anti-TNF biologics as prescribed |
| |
| 004 | systemic non-biological treatments as prescribed |
| |
| 005 | general population non-treated cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| systemic non-biological treatments | Drug | as prescribed |
| |
| anti-TNF biologics |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate incidence of serious infections, malignancies, and other selected outcomes in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis initiating golimumab and other biological and systemic non-biological treatment | The study will be approximately 8 years in duration |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include cohorts of patients who have claims consistent with a diagnosis of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who initiate golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments, within the Ingenix Normative Health Informatics Database.
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| Name | Affiliation | Role |
|---|---|---|
| Anja Geldhof, Eng, Ph.D. | Janssen Biotech, Inc. | Study Director |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C529000 | golimumab |
| D012961 | Sociology |
| ID | Term |
|---|---|
| D012942 | Social Sciences |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
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| Biological |
as prescribed |
|
| golimumab | Biological | as prescribed |
|
| non-anti-TNF biologics | Biological | as prescribed |
|
| general population | Other | non-treated cohort |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |