Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis (CECUM)

May 7, 2026 updated by: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Oral corticosteroids (CS) are the treatment of choice for moderate flares of ulcerative colitis (UC) in patients who are on 5-aminosalicylic acid (5ASA) maintenance therapy. However, the efficacy of oral CS is limited, with up to 50% of remission rate in the available randomized controlled trials (RCTs). By the other hand, uncompleted disease remission after CS use, that is, clinical but not endoscopic remission, has been associated with a higher risk of hospitalizations and need for immunomodulator or colectomy in UC. Uncontrolled data suggests that intravenous CS (IV CS) may increase the remission rate and also reduce the proportion of patients developing steroid-dependency after the index course of CS.

The hypothesis of this study is that the addition of a 3-day high-dose IV CS pulses schedule administered in the outpatient infusion unit, added to a conventional oral CS course increases the endoscopic remission rate and reduces the 1-year proportion of patients developing steroid-dependency.

This is a randomized, phase IV, open-label, multicenter, controlled study.

The planned number of patients to be included is 148, distributed in two treatment arms (with or without initial high-dose CS pulse), and stratified regarding disease onset and mesalazine use.

The main end-point will be the proportion of patients with steroid-free, clinical and endoscopic remission at 8 and 54 weeks, with no rescue therapies.

The demonstration of a higher efficacy of the proposed treatment schedule would impact on a lower requirement for conventional immunosuppressive therapy (thiopurines) and biological agents, reduced hospitalizations and surgery. Moreover, this treatment regimen allows an outpatient management of moderate flares.

Baseline characteristics will be analyzed by descriptive statistical analysis by conventional methods. Categorical variables will be compared using Mann-Whitney test and continuous variables by Student T test.

In order to evaluate the primary endpoint a Chi square test will be performed to compare the proportions of patients in both study groups that achieved clinical and endoscopic steroid-free remission at 8 weeks and is maintained without steroids or salvage therapy and with no rescue therapy up to 54 weeks.

Per protocol (PP) and intention-to-treat (IT) analysis will be made The Per Protocol analysis will include all participants who did adequately adhere to the protocol, in particular those who did received the total amount of the intervention.

Missing outcomes data will be treated as non-response imputation (NRI). The intention-to treat-analysis will only include all randomized patients in the analysis, all retained in the group to which they were allocated, except those patients with missing outcomes that did not completed treatment regimen due to SAE criteria or treatment failure.

In order to evaluate the secondary endpoints a Chi square test and a Student T test will be performed for both study groups.

Cumulative probabilities of relapse, steroid dependency and surgery will be evaluated in both groups by Kaplan-Meiery, and compared by using log-rank test.

Finally, association analysis of early clinical response, clinical and endoscopic remission at week 8 and week 8 and 54 will be performed by chi-square test and Student T test; those variables that reach a Pvalue ≤ 0.1 will be included in the logistic regression analysis.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofía
      • Girona, Spain, 17007
        • Hospital Universitari Dr. Josep Trueta
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital Gregorio Maranon
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal
      • Terrassa, Spain, 08227
        • Mútua de Terrassa
      • Valencia, Spain, 46010
        • Hospital Clínico de Valencia
      • Valencia, Spain
        • Hospital Universitari La Fe
      • Valencia, Spain
        • Hospital de Manises
      • Valencia, Spain, 46010
        • Hospital Universitario General de Valencia
      • Valladolid, Spain, 47012
        • Hospital Universitario Rio Hortega
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain
        • Complejo Hospitalario Universitario Santiago de Compostela
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Manresa, Barcelona, Spain, 08243
        • Althaia, Xarxa Assistencial Universitària de Manresa
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporació Sanitària Parc Taulí
      • Sant Joan Despí, Barcelona, Spain, 08970
        • Hospital Moisès Broggi
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Hospitalari de Terrassa
    • Bilbao
      • Galdakao, Bilbao, Spain
        • Hospital de Galdakao
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • hospital Puerta de Hierro-Majadahonda
    • Ourense
      • Ourense, Ourense, Spain, 32005
        • Hospital Universitario de Ourense
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Hospital Alvaro Cunqueiro
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital Universitario Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: methylprednisolone & prednisone
Intravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone
Drug: Methylprednisolone
Intravenous bolus of methylprednisolone 0.5g/day for 3 consecutive days followed by a decreasing conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d)
Other Names:
  • Urbason
Drug: Prednisone
Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d)
Other Names:
  • URbason
Active Comparator: prednisone
A decreasing conventional course of oral prednisone
Drug: Prednisone
Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d)
Other Names:
  • URbason

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Endoscopic and Clincal Remission
Time Frame: Change from baseline at week 8

The percentage of patients with steroid-free, endoscopic remission, with no rescue therapies.

It has been measured by Mayo endoscopic subscore (MES). MES= 0 (no friability and granularity and intact vascular pattern). MES= 1 (mild erythema or decreased vascular pattern). MES= 2 (marked erythema, absent vascular pattern, friability, and erosions). MES= 3 (spontaneous bleeding and ulceration)
Change from baseline at week 8
Percentage of Participants With Endoscopic and Clinical Remission
Time Frame: Change from baseline at week 54

The proportions of patients with steroid-free, endoscopic remission, with no rescue therapies.

It has been measured by Mayo endoscopic subscore (MES). MES= 0 (no friability and granularity and intact vascular pattern). MES= 1 (mild erythema or decreased vascular pattern). MES= 2 (marked erythema, absent vascular pattern, friability, and erosions). MES= 3 (spontaneous bleeding and ulceration)
Change from baseline at week 54

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Clinical Remission
Time Frame: Change from baseline at week 8.

It was measured as a decrease in the Mayo index score from baseline of at least 3 points; and a decrease of at least 30% in the rectal bleeding variable of at least 1 point or with an absolute value of 0 or 1.

The Mayo index score is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance. Each part is rated from 0 to 3, giving a total score of 0 to 12. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.
Change from baseline at week 8.
Number of Participants With Adverse Events
Time Frame: 12 months
Adverse events (AEs) were collected during the study, from informed consent until the last visit.
12 months
Number of Participants With Serious Adverse Events
Time Frame: 12 months
Serious Adverse Events (SAEs) were defined as any adverse event or adverse drug reaction that resulted in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, or caused a congenital anomaly/birth defect.
12 months
Levels of C-reactive Protein
Time Frame: Baseline
Clinical assessments included the analytical laboratory test. Blood samples were taken for haematology, and C-reactive protein (mg/L) levels were measured.
Baseline
Levels of Serum Albumin
Time Frame: Baseline
Clinical assessments included the analytical laboratory test. Blood samples were taken for haematology, and Serum albumin determination.
Baseline
Levels of Faecal Calprotectin
Time Frame: Baseline
Faecal samples were collected at baseline, frozen and stored at -20 Celsius degrees (ºC) for central measurement of faecal calprotectin (FC).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Investigators

  • Principal Investigator: Eugeni Domènech, MD, PhD, Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Actual)

November 7, 2022

Study Completion (Actual)

November 7, 2022

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimated)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECUM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe