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The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.
he role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| present 5-ASA arm 1 | Active Comparator | oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone |
|
| 5-ASA naive arm 1 | Active Comparator | oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone |
|
| present 5-ASA arm 2 | Active Comparator | IV corticosteroids only / PO Methylprednisolone |
|
| 5-ASA naive arm 2 | Active Comparator | IV corticosteroids only / PO Methylprednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone | Drug | maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients who respond to the treatment | day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| the percentage of patients in need of a rescue medication | day 5, 7 | |
| colectomy rate | 1 month, 3 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| duration of hospitalization | 3-90 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ofir Har-Noy, MD | Sheba Medical Center, Tel-Hashomer, ISRAEL 52621 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 6th affiliated hospital of Sun yat-sen university | Guangzhou | China | ||||
| Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35272029 | Derived | Ben-Horin S, Har-Noy O, Katsanos KH, Roblin X, Chen M, Gao X, Schwartz D, Cheon JH, Cesarini M, Bojic D, Protic M, Theodoropoulou A, Abu-Kaf H, Engel T, Tang J, Veyrard P, Lin X, Mao R, Christodoulou D, Karmiris K, Knezevic-Ivanovski T; ComboMesa investigators. Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2868-2875.e1. doi: 10.1016/j.cgh.2022.02.055. Epub 2022 Mar 8. |
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|
| corticosteroids only | Drug | IV corticosteroids only |
|
|
| Guangzhou |
| China |
| Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne | Saint-Etienne | France |
| Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou | Heraklion | Greece |
| Department of Gastroenterology, University Hospital & Medical School of Ionnina | Ioannina | Greece |
| Gastroenterology department, Soroka medical center | Beersheba | Israel |
| Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Università di Roma Sapienza | Rome | Italy |
| Zvezdara University Clinical Center, Gastroenterology Department | Belgrade | Serbia |
| nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine | Seoul | South Korea |
| 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 |
|---|---|
| D019804 | Mesalamine |
| D006854 | Hydrocortisone |
| C007133 | hydrocortisone hemisuccinate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| 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 |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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