Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis.
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 75
- Locations
- 49
- Primary Endpoint
- Percentage of Participants With Endoscopic and Clincal Remission
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
methylprednisolone & prednisone
Intravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone
Intervention: Methylprednisolone (Drug)
methylprednisolone & prednisone
Intravenous bolus of methylprednisolone followed by a decreasing conventional course of oral prednisone
Intervention: Prednisone (Drug)
prednisone
A decreasing conventional course of oral prednisone
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Endoscopic and Clincal Remission
Time Frame: Change from baseline at week 8
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)
Percentage of Participants With Endoscopic and Clinical Remission
Time Frame: Change from baseline at week 54
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)
Secondary Outcomes
- 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)
- Levels of Faecal Calprotectin(Baseline)