Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis

NCT02921555 | Terminated Phase 4 Results DMC

• 1 other identifier: CECUM
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 29

Brief 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.

Conditions

Ulcerative Colitis

Keywords

RCT (randomized controlled trial)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Endoscopic and Clincal Remission

  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

  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 Outcomes (6)

• Percentage of Patients With Clinical Remission

  Change from baseline at week 8.

• Number of Participants With Adverse Events

  12 months

• Number of Participants With Serious Adverse Events

  12 months

• Levels of C-reactive Protein

  Baseline

• Levels of Serum Albumin

  Baseline

Study Arms (2)

methylprednisolone & prednisone

EXPERIMENTAL

Intravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone

Drug: Methylprednisolone; Drug: Prednisone

prednisone

ACTIVE COMPARATOR

A decreasing conventional course of oral prednisone

Drug: Prednisone

Interventions

Methylprednisolone DRUG

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)

Also known as: Urbason

methylprednisolone & prednisone

Prednisone DRUG

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)

Also known as: URbason

methylprednisolone & prednisone; prednisone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead

Study Sites (29)

Complejo Hospitalario Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Althaia, xarxa assistencial universitaria de Manresa

Manresa, Barcelona, 08243, Spain

Location

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

Consorci Hospitalari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Hospital de Galdakao

Galdakao, Bilbao, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

hospital Puerta de Hierro-Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario de Ourense

Ourense, Ourense, 32005, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital General Universitario de Alicante

Alicante, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitari Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital De La Princesa

Madrid, 28006, Spain

Location

Hospital Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

Mútua de Terrassa

Terrassa, 08227, Spain

Location

Hospital Clínico de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario General de Valencia

Valencia, 46010, Spain

Location

Hospital de Manises

Valencia, Spain

Location

Hospital Universitari La Fe

Valencia, Spain

Location

Hospital Universitario Río Hortega

Valladolid, 47012, Spain

Location

Related Publications (16)

• Dignass A, Lindsay JO, Sturm A, Windsor A, Colombel JF, Allez M, D'Haens G, D'Hoore A, Mantzaris G, Novacek G, Oresland T, Reinisch W, Sans M, Stange E, Vermeire S, Travis S, Van Assche G. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012 Dec;6(10):991-1030. doi: 10.1016/j.crohns.2012.09.002. Epub 2012 Oct 3. No abstract available.

  PMID: 23040451 BACKGROUND

• BARON JH, CONNELL AM, KANAGHINIS TG, LENNARD-JONES JE, JONES AF. Out-patient treatment of ulcerative colitis. Comparison between three doses of oral prednisone. Br Med J. 1962 Aug 18;2(5302):441-3. doi: 10.1136/bmj.2.5302.441. No abstract available.

  PMID: 13865152 BACKGROUND

• Hawthorne AB, Record CO, Holdsworth CD, Giaffer MH, Burke DA, Keech ML, Hawkey CJ. Double blind trial of oral fluticasone propionate v prednisolone in the treatment of active ulcerative colitis. Gut. 1993 Jan;34(1):125-8. doi: 10.1136/gut.34.1.125.

  PMID: 8432442 BACKGROUND

• Sood A, Midha V, Sood N, Kaushal V, Awasthi G. Methylprednisolone acetate versus oral prednisolone in moderately active ulcerative colitis. Indian J Gastroenterol. 2002 Jan-Feb;21(1):11-3.

  PMID: 11871829 BACKGROUND

• Ardizzone S, Cassinotti A, Duca P, Mazzali C, Penati C, Manes G, Marmo R, Massari A, Molteni P, Maconi G, Porro GB. Mucosal healing predicts late outcomes after the first course of corticosteroids for newly diagnosed ulcerative colitis. Clin Gastroenterol Hepatol. 2011 Jun;9(6):483-489.e3. doi: 10.1016/j.cgh.2010.12.028. Epub 2010 Dec 31.

  PMID: 21195796 BACKGROUND

• Elliott PR, Powell-Tuck J, Gillespie PE, Laidlow JM, Lennard-Jones JE, English J, Chakraborty J, Marks V. Prednisolone absorption in acute colitis. Gut. 1980 Jan;21(1):49-51. doi: 10.1136/gut.21.1.49.

  PMID: 7364320 BACKGROUND

• Garcia-Planella E, Manosa M, Van Domselaar M, Gordillo J, Zabana Y, Cabre E, Lopez San Roman A, Domenech E. Long-term outcome of ulcerative colitis in patients who achieve clinical remission with a first course of corticosteroids. Dig Liver Dis. 2012 Mar;44(3):206-10. doi: 10.1016/j.dld.2011.10.004. Epub 2011 Nov 11.

  PMID: 22079262 BACKGROUND

• Rhodes JM, Robinson R, Beales I, Pugh S, Dickinson R, Dronfield M, Speirs CJ, Wilkinson P, Wilkinson SP. Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis. Aliment Pharmacol Ther. 2008 Feb 1;27(3):228-40. doi: 10.1111/j.1365-2036.2007.03569.x. Epub 2007 Nov 6.

  PMID: 17988236 BACKGROUND

• Berghouse LM, Elliott PR, Lennard-Jones JE, English J, Marks V. Plasma prednisolone levels during intravenous therapy in acute colitis. Gut. 1982 Nov;23(11):980-83. doi: 10.1136/gut.23.11.980.

  PMID: 7129207 BACKGROUND

• Llao J, Naves JE, Ruiz-Cerulla A, Marin L, Manosa M, Rodriguez-Alonso L, Cabre E, Garcia-Planella E, Guardiola J, Domenech E. Intravenous corticosteroids in moderately active ulcerative colitis refractory to oral corticosteroids. J Crohns Colitis. 2014 Nov;8(11):1523-8. doi: 10.1016/j.crohns.2014.06.010. Epub 2014 Jul 22.

  PMID: 25066954 BACKGROUND

• Ponticelli C, Glassock RJ, Moroni G. Induction and maintenance therapy in proliferative lupus nephritis. J Nephrol. 2010 Jan-Feb;23(1):9-16.

  PMID: 20091481 BACKGROUND

• Oshitani N, Kamata N, Ooiso R, Kawashima D, Inagawa M, Sogawa M, Iimuro M, Jinno Y, Watanabe K, Higuchi K, Matsumoto T, Arakawa T. Outpatient treatment of moderately severe active ulcerative colitis with pulsed steroid therapy and conventional steroid therapy. Dig Dis Sci. 2003 May;48(5):1002-5. doi: 10.1023/a:1023076318751.

  PMID: 12772803 BACKGROUND

• Sood A, Midha V, Sood N, Awasthi G. A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis. J Clin Gastroenterol. 2002 Oct;35(4):328-31. doi: 10.1097/00004836-200210000-00009.

  PMID: 12352296 BACKGROUND

• Nagata S, Shimizu T, Kudo T, Tomomasa T, Tajiri H, Yoden A, Kagimoto S, Tahara T, Ushijima K, Uchida K, Kobayashi A. Efficacy and safety of pulse steroid therapy in Japanese pediatric patients with ulcerative colitis: a survey of the Japanese Society for Pediatric Inflammatory Bowel Disease. Digestion. 2010;81(3):188-92. doi: 10.1159/000255379. Epub 2010 Jan 19.

  PMID: 20090334 BACKGROUND

• Kudo T, Nagata S, Ohtani K, Fujii T, Wada M, Haruna H, Shoji H, Ohtsuka Y, Shimizu T, Yamashiro Y. Pulse steroids as induction therapy for children with ulcerative colitis. Pediatr Int. 2011 Dec;53(6):974-9. doi: 10.1111/j.1442-200X.2011.03405.x.

  PMID: 21624004 BACKGROUND

• Llao J, Manosa M, Martin-Arranz E, Zabana Y, Navarro-Llavat M, Teller M, Garcia-Planella E, Busquets D, Monfort D, Pineda JR, Gutierrez A, Villoria A, Menchen L, Bastida G, Garcia-Alonso FJ, Rivero M, Chaparro M, de Francisco R, Merino O, Rodriguez-Lago I, Barreiro-de Acosta M, Rodriguez-Fortunez P, Rodriguez-Jimenez C, Calafat M, Domenech E; CECUM study group of the GETECCU. Addition of pulse corticosteroids to oral prednisone in moderately active ulcerative colitis: a randomized, multicentre, open-label study by GETECCU. J Crohns Colitis. 2025 Dec 5;19(11):jjaf182. doi: 10.1093/ecco-jcc/jjaf182.

  PMID: 41258993 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Methylprednisolone; Prednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Limitations and Caveats

Early termination due to low patient recruitment rate, leading to the analysis of half of the proposed sample number.

Results Point of Contact

• Title: Dr. Eugeni Domènech
• Organization: Grupo Español de Trabajo en Enfermedad de Crohn y colitis Ulcerosa

soporte@geteccu.org

635899553

Study Officials

• Eugeni Domènech, MD, PhD

  Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: October 3, 2016
• Study Start: October 11, 2018
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: June 2, 2026
• Results First Posted: February 21, 2025

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (29)