Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.
1 other identifier
interventional
149
7 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2013
Longer than P75 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedMay 9, 2022
May 1, 2022
7.6 years
August 30, 2013
May 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
percentage of patients who respond to the treatment
day 7
Secondary Outcomes (2)
the percentage of patients in need of a rescue medication
day 5, 7
colectomy rate
1 month, 3 months post randomization
Other Outcomes (1)
duration of hospitalization
3-90
Study Arms (4)
present 5-ASA arm 1
ACTIVE COMPARATORoral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
5-ASA naive arm 1
ACTIVE COMPARATORoral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
present 5-ASA arm 2
ACTIVE COMPARATORIV corticosteroids only / PO Methylprednisolone
5-ASA naive arm 2
ACTIVE COMPARATORIV corticosteroids only / PO Methylprednisolone
Interventions
maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids
IV corticosteroids only
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
6th affiliated hospital of Sun yat-sen university
Guangzhou, China
Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University
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
Related Publications (1)
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.
PMID: 35272029DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ofir Har-Noy, MD
Sheba Medical Center, Tel-Hashomer, ISRAEL 52621
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 30, 2013
First Posted
September 13, 2013
Study Start
September 1, 2013
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
May 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share