Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
Launched by SHEBA MEDICAL CENTER · Sep 9, 2013
Trial Information
Current as of June 30, 2025
Completed
Keywords
ClinConnect Summary
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 combin...
Gender
ALL
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
About Sheba Medical Center
Sheba Medical Center, located in Israel, is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, Sheba Medical Center leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes and developing novel therapeutic interventions. The center's collaborative environment fosters partnerships with global research organizations, enhancing its ability to contribute to the scientific community and drive medical advancements across various fields. With a strong focus on patient safety and ethical standards, Sheba Medical Center is dedicated to translating research findings into practical applications that benefit patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tel Hashomer, , Israel
Guangzhou, , China
Guangzhou, , China
Saint Etienne, , France
Heraklion, , Greece
Ioánnina, , Greece
Be'er Sheva', , Israel
Rome, , Italy
Seoul, , Korea, Republic Of
Belgrade, , Serbia
Patients applied
Trial Officials
Ofir Har-Noy, MD
Principal Investigator
Sheba Medical Center, Tel-Hashomer, ISRAEL 52621
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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