Intravenous corticosteroids in moderate ulcerative colitis

Phase 1

Conditions: Moderate flares of Ulcerative Colitis
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-001170-15-ES

Lead Sponsor: GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 148

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course for moderate flares of ulcerative colitis.;Secondary Objective: - Clinical response<br>- Biological response<br>- Rate of adverse events<br>- Rate of serious adverse events<br>- Proportion of patients with clinical recurrence<br>- Time to clinical relapse<br>- Risk of hospitalization<br>- Time to corticodependency<br>- Number of participants with surgery events<br>- Proportion of patients with corticodependency criteria<br>;Primary end point(s): Clinical Remission : <br>The proportions of patients with steroid-free, clinical and endoscopic remission, with no rescue therapies.<br>It will be measured as Mayo index score = 2 points with any single variable >1.;Timepoint(s) of evaluation of this end point: week 8 and week 54

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Clinical response<br>- Early clinical response <br>- Endoscopic remission<br>- Relapse,<br>- Corticodependence<br>- Rescue treatment:;Timepoint(s) of evaluation of this end point: week 8 and week 54<br>day 3, day 7, week 8 and week 54