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Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biologics group | Placebo Comparator | Biologics including infliximab and vedolizumab. infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks. vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks. |
|
| 5-ASA group | Experimental | 5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks. vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks. mesalazine: at a dose of 4-6g/d systemic or topical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| endoscopic remission rate at 12 months | endoscopic remission rate at 12 months | 12 months after first intervention administration |
| Measure | Description | Time Frame |
|---|---|---|
| normalization rate of serum biomarker at 12 months | normalization rate of serum biomarker at 12 months | 12 months after first intervention administration |
| normalization rate of serum biomarker at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Chongqing | Chongqing | Chongqing Municipality | China | |||
| the Sixth Affiliated Hospital of Sun Yat-Sen University |
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| Vedolizumab | Drug | Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks |
|
| Mesalazine | Drug | Mesalazine, 4-6g/d, systemic and/or topical administration |
|
normalization rate of serum biomarker at 6 months
| 6 months after first intervention administration |
| clinical remission rate at 12 months | clinical remission rate at 12 months | 12 months after first intervention administration |
| clinical remission rate at 6 months | clinical remission rate at 6 months | 6 months after first intervention administration |
| clinical response rate at 12 months | clinical response rate at 12 months | 12 months after first intervention administration |
| clinical response rate at 6 months | clinical response rate at 6 months | 6 months after first intervention administration |
| endoscopic remission rate at 6 months | endoscopic remission rate at 6 months | 6 months after first intervention administration |
| endoscopic response rate at 12 months | endoscopic response rate at 12 months | 12 months after first intervention administration |
| endoscopic response rate at 6 months | endoscopic response rate at 6 months | 6 months after first intervention administration |
| life quality changes at 12 months | life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months | 12 months after first intervention administration |
| life quality changes at 6 months | life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months | 6 months after first intervention administration |
| Guangzhou |
| Guangdong |
| 501655 |
| China |
| First People's Hospital of Foshan | Guangzhou | Guangdong | China |
| Guangzhou Panyu Central Hospital | Guangzhou | Guangdong | China |
| Nanhai Hospital, Southern Medical University | Guangzhou | Guangdong | China |
| Shunde Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| First Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | China |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
| Shengjing Hospital | Shenyang | Liaoning | China |
| General Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | China |
| Zhejiang University | Hanzhou | Zhejiang | 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 |
|---|---|
| D000069285 | Infliximab |
| C543529 | vedolizumab |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
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