TerminatedPhase 4

Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis

Stopped: slow recruitment rate

Spain75 participantsStarted 2018-10-11

Plain-language summary

The purpose of this study is to determine the efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course for moderate flares of ulcerative colitis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ulcerative colitis diagnosis by Lennard-Jones criteria * ≥18 years * Left or extended extent of disease * Moderate flares of ulcerative colitis according to disease activity index (DAI) * No maintenance therapy or 5ASA treatment * The patient is available to understand study procedures and to sign the inform consent form * Inform Consent Form Exclusion Criteria: * Previous or current thiopurines, methotrexate or biological treatment * Administration of systemic corticoids the last 6 months * Acute or moderate systemic infection * Diabetes mellitus or arterial hypertension * Pregnancy or breastfeeding * Allergic reactions associated to corticosteroids therapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Endoscopic and Clincal Remission

Timeframe: Change from baseline at week 8

Percentage of Participants With Endoscopic and Clinical Remission

Timeframe: Change from baseline at week 54

Trial details

NCT IDNCT02921555

SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-07

Results submitted2024-09-04

View on ClinicalTrials.gov More Ulcerative Colitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.