Ulcerative Colitis
Conditions
Brief summary
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
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.
Interventions
DRUGoral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids
DRUGcorticosteroids only
IV corticosteroids only
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients who respond to the treatment | day 7 |
Secondary
| Measure | Time frame |
|---|---|
| the percentage of patients in need of a rescue medication | day 5, 7 |
| colectomy rate | 1 month, 3 months post randomization |
Other
| Measure | Time frame |
|---|---|
| duration of hospitalization | 3-90 |
Countries
China, France, Greece, Israel, Italy, Serbia, South Korea
Outcome results
None listed