Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
* Drug: corticosteroids only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: UC known and diagnosed by established clinical-endoscopic and histological criteria or newly-diagnosed UC, based on clinical and endoscopic findings, and about to start treatment with corticosteroids. current hospitalization with severe Ulcerative Colitis exacerbation as defined by a Lichtiger score of >10 age >18 if taking thiopurines, the dose must be stable for 2 months prior to admission Exclusion Criteria: pregnant women allergy/unable to take study medications active infection severe renal/liver/cardiorespiratory condition toxic megacolon or signs of imminent colectomy treatment with an anti-tumor necrosis factor in 3 months prior to admission prior treatment with cyclosporin or tacrolimus alcohol dependancy unwilling/ unable to give an informed consent participation in clinical trials in the last 2 months prior to admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: present 5-ASA arm 1<br>oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone<br>* maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids<br>* Other names: methylprednisolone;|
| Active Comparator: 5-ASA naive arm 1<br>oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone<br>* maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids<br>* Other names: methylprednisolone;|
| Active Comparator: present 5-ASA arm 2<br>IV corticosteroids only / PO Methylprednisolone | Drug: corticosteroids only<br>* IV corticosteroids only<br>* Other names: methylprednisolone;|
| Active Comparator: 5-ASA naive arm 2<br>IV corticosteroids only / PO Methylprednisolone | Drug: corticosteroids only<br>* IV corticosteroids only<br>* Other names: methylprednisolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients who respond to the treatment |  | day 7 | 

Secondary Outcome Measures

| Outcome Measure | 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 |