Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis

NCT ID: NCT01941589

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2021-04-30

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

present 5-ASA arm 1

oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

Group Type: ACTIVE_COMPARATOR

oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

Intervention Type: DRUG

maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids

5-ASA naive arm 1

oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

Group Type: ACTIVE_COMPARATOR

oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

Intervention Type: DRUG

maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids

present 5-ASA arm 2

IV corticosteroids only / PO Methylprednisolone

Group Type: ACTIVE_COMPARATOR

corticosteroids only

Intervention Type: DRUG

IV corticosteroids only

5-ASA naive arm 2

IV corticosteroids only / PO Methylprednisolone

Group Type: ACTIVE_COMPARATOR

corticosteroids only

Intervention Type: DRUG

IV corticosteroids only

Interventions

oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids

Intervention Type: DRUG

corticosteroids only

IV corticosteroids only

Intervention Type: DRUG

Other Intervention Names

rafassal; pentasa; asacol; hydrocortisone; solu-cortef; methylprednisolone; hydrocortisone; solu-cortef; methylprednisolone

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Ofir Harnoy MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ofir Har-Noy, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center, Tel-Hashomer, ISRAEL 52621

Locations

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, , 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

Countries

China; France; Greece; Israel; Italy; Serbia; South Korea

References

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.

Reference Type: DERIVED

PMID: 35272029 (View on PubMed)

Other Identifiers

SHEBA-13-0401-OH-CTIL

Identifier Type: -

Identifier Source: org_study_id