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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO148UCO4001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simponi-exposed cohort | Participants receiving Simponi at enrollment and are still receiving Simponi after participation in a therapeutic trial or participants scheduled to receive Simponi within 30 days after enrollment. Participants in this cohort may be receiving Simponi alone or in combination with thiopurines but must not be receiving other approved biologics or investigational agents at enrollment. Participants may have received other approved biologics or investigational agents prior to enrollment. | ||
| Thiopurine cohort | Participants currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry. Participants must not be receiving approved biologic agents, including Simponi, or investigational agents at enrollment. These patients may have received biologics other than Simponi or investigational agents prior to enrollment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies | Descriptive analysis of serious adverse events, adverse events of interest (including lymphoma & other malignancies), pregnancies, and non-serious malignancies in participants less than (<) 30 years of age will be reported. | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Disease Status as Assessed by Partial Mayo Score | The partial Mayo score, a validated tool used to assess disease status in participants with ulcerative colitis, will be utilized to assess clinical status in this registry. Information will be obtained using 3 of the individual components of the full Mayo score, including stool frequency, rectal bleeding, and PGA (Physician's Global Assessment). Each component score ranges from 0 (normal) to 3 (severe disease) and the score is the sum of those three categories. The total Partial Mayo Score will be calculated as the sum of the scores of all 3 components for each participant that ranges from 0-9. |
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Inclusion Criteria:
Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past
For enrollment into the Simponi-exposed cohort meets one of the following:
For Thiopurine cohort:
Exclusion Criteria:
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Participants with moderate-to-severe ulcerative colitis for at least 3 months prior to enrollment will be observed
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Biotech, Inc. Clinical Trial | Janssen Biotech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Murrieta | California | United States | ||||
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| 6 years |
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The total score ranges from 10 (worst health) to 70 (best health). | 6 years |
| EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score | The EQ-5D-5L is a standardized non-disease specific instrument for describing and assessing health-related quality of life.This instrument evaluates 5 areas including mobility, ability for self-care, ability in usual activities, pain/discomfort and anxiety/depression.There also is a self-evaluated 100-point health assessment. | 6 years |
| Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC) | The WPAI-UC is a validated instrument that measures the effect of ulcerative colitis (UC) symptoms on a patient's life (eg, diarrhea, loss of appetite, weight loss, abdominal pain, fever, joint pain, skin sores, rectal bleeding) and on his or her ability to work and perform regular activities. | 6 years |
| Treatment Satisfaction Questionnaire for Medication (TSQM) Score | The TSQM is a 14-question instrument that gauges a patient's experience with his or her medication.The questionnaire was designed to evaluate the effectiveness, side effects, and convenience of the medication over a period of 2- to 3-weeks or since the last time it was taken. | 6 years |
| Health Care Utilization: Evaluate the Number of Each Hospitalizations in Participants in Each Cohort | Number of hospitalizations in participants in each cohort will be reported. | 6 years |
| Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort | Reasons for hospitalization in participants in each cohort will be reported. | 6 years |
| Rialto |
| California |
| United States |
| Ventura | California | United States |
| Coral Gables | Florida | United States |
| Fort Myers | Florida | United States |
| Lake Worth | Florida | United States |
| Lauderdale Lakes | Florida | United States |
| Miami | Florida | United States |
| Tampa | Florida | United States |
| Suwanee | Georgia | United States |
| Chicago | Illinois | United States |
| Sylvania | Ohio | United States |
| Pittsburgh | Pennsylvania | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Lansdowne Town Center | Virginia | United States |
| Salzburg | Austria |
| Sankt Poelten Noe | Austria |
| Vienna | Austria |
| New Westminster | British Columbia | Canada |
| Vancouver | British Columbia | Canada |
| Oshawa | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Pilsen | Czechia |
| Clermont-Ferrand | France |
| Clichy | France |
| Créteil | France |
| Grenoble | France |
| Montpellier | France |
| Nice | France |
| Pierre-Bénite | France |
| Saint-Priest-en-Jarez | France |
| Strasbourg | France |
| Berlin | Germany |
| Dessau Roblau | Germany |
| Halle | Germany |
| Hamburg | Germany |
| Heidelberg | Germany |
| Kiel | Germany |
| Leipzig | Germany |
| Ludwigshafen | Germany |
| Lyneburg | Germany |
| München | Germany |
| Saarbrücken | Germany |
| Athens | Greece |
| Heraklion | Greece |
| Ioannina | Greece |
| Thessaloniki | Greece |
| Busan | South Korea |
| Gyeonggi-do | South Korea |
| Seongnam-si | South Korea |
| Seoul | South Korea |
| A Coruña | Spain |
| Barcelona | Spain |
| Córdoba | Spain |
| Fuenlabrada | Spain |
| Huelva | Spain |
| Madrid | Spain |
| Majadahonda | Spain |
| San Sebastián de los Reyes | Spain |
| Valencia | Spain |
| Vigo | Spain |
| Zaragoza | Spain |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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