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Steroid combo fails to show benefit for UC flares

NCT ID NCT02921555

Symptom relief Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding high-dose steroid pulses to the usual oral steroid course could help people with moderate ulcerative colitis flares achieve remission without needing other treatments. The trial was terminated early and enrolled 75 adults with left-sided or extensive colitis. The main goal was to see if the combination led to steroid-free endoscopic remission.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

75 people

The number who actually took part.

Started

Oct 2018

Finished

Nov 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • Althaia, xarxa assistencial universitaria de Manresa

    Manresa, Barcelona, 08243, Spain

  • Complejo Hospitalario Universitario Santiago de Compostela

    Santiago de Compostela, A Coruña, Spain

  • Consorci Corporació Sanitària Parc Taulí

    Sabadell, Barcelona, 08208, Spain

  • Consorci Hospitalari de Terrassa

    Terrassa, Barcelona, 08227, Spain

  • Hospital 12 de Octubre

    Madrid, Spain

  • Hospital Clínico de Valencia

    Valencia, 46010, Spain

  • Hospital De La Princesa

    Madrid, 28006, Spain

  • Hospital General Universitario de Alicante

    Alicante, Spain

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Moisès Broggi

    Sant Joan Despí, Barcelona, 08970, Spain

  • Hospital Universitari Dr. Josep Trueta

    Girona, 17007, Spain

  • Hospital Universitari La Fe

    Valencia, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903, Spain

  • Hospital Universitario General de Valencia

    Valencia, 46010, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario Río Hortega

    Valladolid, 47012, Spain

  • Hospital Universitario de Ourense

    Ourense, Ourense, 32005, Spain

  • Hospital de Galdakao

    Galdakao, Bilbao, Spain

  • Hospital de Manises

    Valencia, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra, 36312, Spain

  • Mútua de Terrassa

    Terrassa, 08227, Spain

  • hospital Puerta de Hierro-Majadahonda

    Majadahonda, Madrid, 28222, Spain

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