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.

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone; Drug: corticosteroids only

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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • 6th affiliated hospital of Sun yat-sen university
  • Guangzhou, China
    • Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University
• France
  • Saint-Etienne, France
    • Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne
• Greece
  • Heraklion, Greece
    • Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou
  • Ioánnina, Greece
    • Department of Gastroenterology, University Hospital & Medical School of Ionnina
• Israel
  • Be'er Sheva', Israel
    • Gastroenterology department, Soroka medical center
  • Tel HaShomer, Israel, 52621
    • Sheba Medical Center
• Italy
  • Rome, Italy
    • Università di Roma Sapienza
• Korea, Republic of
  • Seoul, Korea, Republic of
    • nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine
• Serbia
  • Belgrade, Serbia
    • Zvezdara University Clinical Center, Gastroenterology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: present 5-ASA arm 1; oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone	Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone; maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids; Other Names: methylprednisolone; hydrocortisone; solu-cortef; rafassal; pentasa; asacol
Active Comparator: 5-ASA naive arm 1; oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone	Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone; maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids; Other Names: methylprednisolone; hydrocortisone; solu-cortef; rafassal; pentasa; asacol
Active Comparator: present 5-ASA arm 2; IV corticosteroids only / PO Methylprednisolone	Drug: corticosteroids only; IV corticosteroids only; Other Names: methylprednisolone; hydrocortisone; solu-cortef
Active Comparator: 5-ASA naive arm 2; IV corticosteroids only / PO Methylprednisolone	Drug: corticosteroids only; IV corticosteroids only; Other Names: methylprednisolone; hydrocortisone; solu-cortef

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
duration of hospitalization	3-90

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Ofir Har-Noy, MD, Sheba Medical Center, Tel-Hashomer, ISRAEL 52621

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
• Other Study ID Numbers: SHEBA-13-0401-OH-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO