Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 6 March 2023
• Main ID: NCT02921555
• Date of registration: 22/09/2016
• Prospective Registration: Yes
• Primary sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
• Public title: Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis CECUM
• Scientific title: Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis.
• Date of first enrolment: October 11, 2018
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02921555
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Spain

Contacts

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

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Methylprednisolone

Drug: Prednisone

Primary Outcome(s)

Clinical Remission [Time Frame: Change from baseline, at 8 and 54 weeks]

Secondary Outcome(s)

Rate of serious adverse events [Time Frame: 2 years]

Number of participants with surgery events [Time Frame: 2 years]

Proportion of patients with corticodependency criteria [Time Frame: 2 years]

Clinical response [Time Frame: at week 8 and 54 from baseline]

Rate of adverse events [Time Frame: 2 years]

Time to corticodependency [Time Frame: 2 years]

Time to clinical relapse [Time Frame: 2 years]

Risk of hospitalization [Time Frame: 2 years]

Biological response [Time Frame: at week 8 and 54 from baseline]

Proportion of patients with clinical recurrence [Time Frame: 2 years]

Secondary ID(s)

CECUM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors