Clinical trial NCT01941589: Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
Official title: Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-13
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of patients who respond to the treatment
timeFrame: day 7
Secondary outcomes:
measure: the percentage of patients in need of a rescue medication
timeFrame: day 5, 7
measure: colectomy rate
timeFrame: 1 month, 3 months post randomization
Other outcomes:
measure: duration of hospitalization
timeFrame: 3-90
Locations:
city: Guangzhou
country: China
facility: 6th affiliated hospital of Sun yat-sen university
city: Guangzhou
country: China
facility: Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University
city: Saint-Etienne
country: France
facility: Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne
city: Heraklion
country: Greece
facility: Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou
city: Ioánnina
country: Greece
facility: Department of Gastroenterology, University Hospital & Medical School of Ionnina
city: Be'er Sheva'
country: Israel
facility: Gastroenterology department, Soroka medical center
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
city: Rome
country: Italy
facility: Università di Roma Sapienza
city: Seoul
country: Korea, Republic of
facility: nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine
city: Belgrade
country: Serbia
facility: Zvezdara University Clinical Center, Gastroenterology Department
Study officials:
affiliation: Sheba Medical Center, Tel-Hashomer, ISRAEL 52621
name: Ofir Har-Noy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.