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Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis (CECUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02921555
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : July 8, 2019
Information provided by (Responsible Party):
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Methylprednisolone Drug: Prednisone Phase 4

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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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis.
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 15, 2020

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 Name: 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 Name: 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 Name: URbason

Primary Outcome Measures :
  1. Clinical Remission [ Time Frame: Change from baseline, at 8 and 54 weeks ]

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

    It will be measured as Mayo index score ≤ 2 points with any single variable >1.

Secondary Outcome Measures :
  1. Clinical response [ Time Frame: at week 8 and 54 from baseline ]
    It will be measured as a decrease in Mayo index score of at least 3 points and at least 30% decrease of the rectal bleeding variable of at least 1 point or with an absolute value of 0 or 1.

  2. Biological response [ Time Frame: at week 8 and 54 from baseline ]
  3. Rate of adverse events [ Time Frame: 2 years ]
  4. Rate of serious adverse events [ Time Frame: 2 years ]
  5. Proportion of patients with clinical recurrence [ Time Frame: 2 years ]
  6. Time to clinical relapse [ Time Frame: 2 years ]
  7. Risk of hospitalization [ Time Frame: 2 years ]

    The risk of hospitalization will be measured by SAE criteria:

    • Death
    • Life-threatening
    • Hospitalization (initial or prolonged)
    • Disability or Permanent Damage
    • Congenital Anomaly/Birth Defect
    • Required Intervention to Prevent Permanent Impairment or Damage (Devices)
    • Other Serious (Important Medical Events)

  8. Time to corticodependency [ Time Frame: 2 years ]
  9. Number of participants with surgery events [ Time Frame: 2 years ]
    assessed by disease activity index (DAI) and simple activity index

  10. Proportion of patients with corticodependency criteria [ Time Frame: 2 years ]
    Relapse during dose reduction of prednisolone or within 3 months after the discontinuation of steroid treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02921555

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Contact: Anna Casas 635 899 553
Contact: Eugeni Domènech

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Complejo Hospitalario Universitario Santiago de Compostela Recruiting
Santiago de Compostela, A Coruña, Spain
Contact    981540500      
Principal Investigator: Manuel Barreiro, MD         
Hospital Universitario Central de Asturias Active, not recruiting
Oviedo, Astúrias, Spain, 33011
Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Eugeni Domenech, MD, PhD    934651200   
Sub-Investigator: Eugeni Domenech, MD PhD         
Principal Investigator: Miriam Mañosa, Dr         
Sub-Investigator: Fiorella Cañete, Dr         
Althaia, xarxa assistencial universitaria de Manresa Recruiting
Manresa, Barcelona, Spain, 08243
Principal Investigator: Jordina Llaó, MD         
Consorci Corporació Sanitària Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Principal Investigator: Albert Villoria, MD         
Hospital Moisès Broggi Active, not recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Consorci Hospitalari de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08227
Principal Investigator: David Montfort i Miquel, MD         
Hospital de Galdakao Active, not recruiting
Galdakao, Bilbao, Spain
Hospital Universitario Marqués de Valdecilla Active, not recruiting
Santander, Cantabria, Spain, 39008
hospital Puerta de Hierro-Majadahonda Active, not recruiting
Majadahonda, Madrid, Spain, 28222
Hospital Universitario de Ourense Active, not recruiting
Orense, Ourense, Spain, 32005
Hospital Álvaro Cunqueiro Recruiting
Vigo, Pontevedra, Spain, 36312
Principal Investigator: JUAN RAMON PINEDA MARIÑO, MD         
Hospital San Juan de Dios Aljarafe Not yet recruiting
Bormujos, Sevilla, Spain, 41930
Principal Investigator: YOLANDA TORRES DOMÍNGUEZ, MD         
Hospital Universitario Cruces Active, not recruiting
Baracaldo, Vizcaya, Spain, 48903
Hospital General Universitario de Alicante Active, not recruiting
Alicante, Spain
Hospital de la Santa Creu i Sant Pau Active, not recruiting
Barcelona, Spain
Hospital del Mar Active, not recruiting
Barcelona, Spain
Hospital universitario de ceuta Not yet recruiting
Ceuta, Spain, 51003
Principal Investigator: Francisco Javier Guerrero Gallego, MD         
Hospital Universitario Reina Sofia Active, not recruiting
Córdoba, Spain, 14004
Hospital Universitari Dr. Josep Trueta Active, not recruiting
Girona, Spain, 17007
Hospital De La Princesa Active, not recruiting
Madrid, Spain, 28006
Hospital Gregorio Marañon Recruiting
Madrid, Spain, 28007
Principal Investigator: LUIS MENCHÉN VISO, MD         
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain, 28040
Principal Investigator: Carlos Taxonera, MD         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Principal Investigator: EDUARDO MARTÍN ARRANZ, DM         
Hospital 12 de Octubre Recruiting
Madrid, Spain
Principal Investigator: Pilar Martínez -Montiel, MD PhD         
Hospital Universitario Ramon y Cajal Active, not recruiting
Madrid, Spain
Mútua de Terrassa Active, not recruiting
Terrassa, Spain, 08227
Hospital Clínico de Valencia Active, not recruiting
Valencia, Spain, 46010
Hospital Universitario General de Valencia Active, not recruiting
Valencia, Spain, 46010
Hospital de Manises Active, not recruiting
Valencia, Spain
Hospital Universitari La Fe Active, not recruiting
Valencia, Spain
Hospital Universitario Clinico de Valladolid Active, not recruiting
Valladolid, Spain, 47003
Hospital Universitario Río Hortega Active, not recruiting
Valladolid, Spain, 47012
Hospital clínico Universitario Lozano Blesa Active, not recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
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Principal Investigator: Eugeni Domènech, MD, PhD Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa


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Responsible Party: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Identifier: NCT02921555     History of Changes
Other Study ID Numbers: CECUM
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa:
RCT (randomized controlled trial)

Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents