Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).

NCT02665845 | Completed Phase 3

• 2 other identifiers: 15080902015-002671-21
• Study Type: interventional
• Target: 160
• Locations: 6 countries
• Sites: 6

Brief Summary

The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation. The aim of this study is to compare the efficacy of steroids alone vs. combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who respond to the treatment by day 7.

  The primary endpoint will be the percentage of patients who respond to the treatment by day 7. Response will be defined by a drop of \>3 points in the lichtiger score and an absolute score \<10 on the two prior consecutive days without the need for rescue medications or surgery. In patients who improve and are discharged prior to day 7, the lichtiger score will be calculated based on the two last days of hospitalization, provided that at least 3 days of study medications were dispensed. Patients discharged before 3 days of study medications have been administered will be considered in-eligible and will be dropped out of the analyses.

  Day 7

Study Arms (2)

5-ASA group

EXPERIMENTAL

Patients will receive corticosteroids with optimized 5-ASA.

Drug: 5-ASA; Drug: Corticosteroids

Control group

ACTIVE COMPARATOR

Patients will receive corticosteroids alone.

Drug: Corticosteroids

Interventions

5-ASA DRUG

5ASA treatment (oral 5ASA will be given to all patients in this arm, in addition to topical 5ASA in patients who tolerate it).

Also known as: 5-aminosalicylates

5-ASA group

Corticosteroids DRUG

Corticosteroids will be given to all patients.

Also known as: Usual care

5-ASA group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 UC exacerbation as defined by a Lichtiger score of \>10
• Age \>18
• Has not been on oral systemic corticosteroids more than 14 days prior to hospitalization
• If taking a thiopurine, the dose need to be stable for the last 2 months before admission

You may not qualify if:

• Pregnant women
• Allergy / unable to take prednisone / hydrocortisone/ 5-ASA.
• Active infection - either enteric or elsewhere
• Severe renal, liver or cardio respiratory comorbidity
• Toxic megacolon, or clinical features suggestive of a need for imminent colectomy
• Treatment with an anti-TNF within the prior 3 months
• Prior treatment with cyclosporine or tacrolimus within the prior 3 months
• Alcohol dependency
• Unable or unwilling to provide informed consent
• Participating in other clinical trial within the 2 months prior to admission

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (6)

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

Heraklion, Greece

Location

Sheba Medical Center

Tel Litwinsky, Ramat-Gan, Israel

Location

Università di Roma Sapienza

Rome, Italy

Location

Zvezdara University Clinical Center, Gastroenterology Department

Belgrade, Serbia

Location

Institute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• ROBLIN Xavier, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: June 13, 2016
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); FR (1); IL (1); GR (1); KR (1); IT (1)