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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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This is an observational study of a prospective cohort of guselkumab-initiating Crohn's Disease (CD) and Ulcerative Colitis (UC) patients to identify new or incident spondyloarthritis. This study will include adult patients aged 18-75 with IBD who are undergoing guselkumab intravenous or subcutaneous induction over a 1-year timeframe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD Patients Initiating Guselkumab | Individuals with confirmed clinical SpA diagnosis who are initiating guselkumab as standard care for CD or UC will take surveys every 3 months over a 1-year timeframe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab intravenous or subcutaneous induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | BASDAI is a self-reported tool consisting of 6 questions evaluating fatigue, spinal pain, joint pain/swelling, areas of localized tenderness, and morning stiffness (duration and severity). Responses are on a 0-10 numeric rating scale; the final score is the average of responses and ranges from 0-10; higher scores indicate greater overall disease activity. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP) | ASDAS-CRP is a composite score that includes four patient's self-reported pain and stiffness questions, combined with C-reactive protein (CRP) levels, a marker of inflammation in the blood. The score helps assess how active the disease is and how well a treatment is working. The composite score categorizes patients as follows:
|
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Inclusion Criteria:
Exclusion Criteria:
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CD or UC patients initiating guselkumab.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathasha Melukkaran | Contact | 646-754-3417 | Nathasha.melukkaran@nyulangone.org | |
| Peik Sean Chong | Contact | 646-754-3417 | Peiksean.chong@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| David Hudesman, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Data will be shared only with funder (Janssen).
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| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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| Baseline, Month 6 |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |