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The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to relapse according to the patients with different maintenance Etiasa® daily dose | Until relapse or maximum 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rates at 5 years or at study termination according to different maintenance Etiasa® daily dose | 5 years or at study termination | |
| Calprotectin change from baseline to each hospital visit and relapse | From baseline up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Beijing Chao-yang Hospital of Capital Medical University | Beijing | 100021 | China | |||
| Peking University First Hospital |
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| Hemoglobin change from baseline to each hospital visit and relapse | From baseline up to 5 years |
| C-reactive protein (CRP) change from baseline to each hospital visit and relapse | From baseline up to 5 years |
| Erythrocyte sedimentation rate (ESR) change from baseline to each hospital visit and relapse | From baseline up to 5 years |
| Interleukin-6 (IL-6) change from baseline to each hospital visit and relapse | From baseline up to 5 years |
| Colorectal cancer (CRC) incidence rate | Until relapse or maximum 5 years |
| Quality of Life (QoL) changes during the treatment | Assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (score 10-70, poor to good HRQoL). | From baseline until relapse or 5 years or early termination |
| Beijing |
| 100034 |
| China |
| China-Japan Union Hospital of Jilin University | Changchun | 130033 | China |
| The Third Affiliated Hospital of The Third Military Medical University of Chinese PLA | Chongqing | 400042 | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | 116000 | China |
| The First Affiliated Hospital of Sun Yatsen University | Guangzhou | 510080 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | 510515 | China |
| The Sixth Affiliated Hospital of Sun Yatsen University | Guangzhou | 510655 | China |
| Hebi People Hospital | Hebi | 450018 | China |
| Anhui Provincial Hospital | Hefei | 230001 | China |
| Henan Province People Hospital | Henan | 450003 | China |
| The PLA 150 Central Hospital | Luoyang | 471031 | China |
| The First Affiliated hospital of Nan Chang University | Nanchang | 330006 | China |
| Nanjing General Hospital of Nanjing Military Command | Nanjing | 210002 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| Jiangsu Province Hospital of TCM | Nanjing | 210029 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | 266003 | China |
| Qingdao Municipal Hospital | Qingdao | 266034 | China |
| Suzhou Third People Hospital | Suzhou | 215000 | China |
| The second affiliated hospital of Suzhou University | Suzhou | 215004 | China |
| Tianjin People's Hospital | Tianjin | 300121 | China |
| The Second Hospital Affiliated to Wenzhou Medical College | Wenzhou | 325000 | China |
| Union Hospital Affiliated to Tongji Medical College | Wuhan | 430030 | China |
| The People's Hospital of Wuhan University | Wuhan | 430060 | China |
| The First Affiliated Hospital of the Fourth Military Medical University | Xi'an | 100142 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450001 | China |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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