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Ulcerative ColitisPhase 4CECUMNCT02921555

Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis

A Phase 4 study testing Methylprednisolone and Prednisone in people with Ulcerative Colitis, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 29 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Methylprednisolone and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
29 sitesSpain
Study dates
11 Oct 2018to 7 Nov 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Spain29 sites

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital de Galdakao

    Galdakao, Bilbao

  • Hospital Universitari Dr. Josep Trueta

    Girona, 17007

  • Hospital De La Princesa

    Madrid, 28006

  • Hospital Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital 12 de Octubre

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • hospital Puerta de Hierro-Majadahonda

    Majadahonda, Madrid, 28222

  • Althaia, xarxa assistencial universitaria de Manresa

    Manresa, Barcelona, 08243

  • Hospital Universitario de Ourense

    Ourense, Ourense, 32005

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Consorci Corporació Sanitària Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Moisès Broggi

    Sant Joan Despí, Barcelona, 08970

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Complejo Hospitalario Universitario Santiago de Compostela

    Santiago de Compostela, A Coruña

  • Consorci Hospitalari de Terrassa

    Terrassa, Barcelona, 08227

  • Mútua de Terrassa

    Terrassa, 08227

  • Hospital Clínico de Valencia

    Valencia, 46010

  • Hospital Universitario General de Valencia

    Valencia, 46010

  • Hospital de Manises

    Valencia

  • Hospital Universitari La Fe

    Valencia

  • Hospital Universitario Río Hortega

    Valladolid, 47012

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Keywords
RCT (randomized controlled trial)
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylprednisoloneDrug

    Also called Urbason

    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)

  • PrednisoneDrug

    Also called URbason

    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)

Study groups in NCT02921555
Study groupRoleWhat they receive
methylprednisolone & prednisoneExperimentalIntravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone
Receives: Drug: Methylprednisolone; Drug: Prednisone
prednisoneActive comparatorA decreasing conventional course of oral prednisone
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Change from baseline at week 8

  2. 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)

    Measured: Change from baseline at week 54

Secondary outcomes (6)

  1. Percentage of Patients With Clinical Remission

    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.

    Measured: Change from baseline at week 8.

  2. Number of Participants With Adverse Events

    Adverse events (AEs) were collected during the study, from informed consent until the last visit.

    Measured: 12 months

  3. Number of Participants With Serious Adverse Events

    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.

    Measured: 12 months

  4. Levels of C-reactive Protein

    Clinical assessments included the analytical laboratory test. Blood samples were taken for haematology, and C-reactive protein (mg/L) levels were measured.

    Measured: Baseline

  5. Levels of Serum Albumin

    Clinical assessments included the analytical laboratory test. Blood samples were taken for haematology, and Serum albumin determination.

    Measured: Baseline

  6. Levels of Faecal Calprotectin

    Faecal samples were collected at baseline, frozen and stored at -20 Celsius degrees (ºC) for central measurement of faecal calprotectin (FC).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2016 (estimated)
  2. Study start11 Oct 2018
  3. Primary completion7 Nov 2022
  4. Study completion7 Nov 2022

Why it stopped: slow recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02921555
Sponsor's protocol ID
CECUM
Acronym
CECUM
Status last verified
May 2026
First submitted
22 Sep 2016
Last updated
2 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23040451

  • 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.

    PubMed 13865152

  • 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.

    PubMed 8432442

  • 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.

    PubMed 11871829

  • 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.

    PubMed 21195796

  • 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.

    PubMed 7364320

  • 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.

    PubMed 22079262

  • 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.

    PubMed 17988236

  • 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.

    PubMed 7129207

  • 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.

    PubMed 25066954

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

    PubMed 20091481

  • 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.

    PubMed 12772803

  • 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.

    PubMed 12352296

  • 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.

    PubMed 20090334

  • 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.

    PubMed 21624004

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methylprednisolone and Prednisone in people with Ulcerative Colitis, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 29 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Endoscopic and Clincal Remission (time frame: Change from baseline at week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02921555, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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