NCT02921555: CECUM

Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis

Terminated Phase 4 Results posted Last updated 21 February 2025

What this trial tests

Phase 4 trial testing Methylprednisolone in Ulcerative Colitis in 75 participants. Terminated before completion.

Timeline

11 October 2018

Primary endpoint
7 November 2022

7 November 2022

Quick facts

Lead sponsor	Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	75
Start date	11 October 2018
Primary completion	7 November 2022
Estimated completion	7 November 2022
Sites	29 locations across Spain

Drugs / interventions tested

• Methylprednisolone (methylprednisolone) — full drug profile →
• Prednisone (prednisone) — full drug profile →

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa — full company profile →

Who can join

18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Endoscopic and Clincal Remission Primary · 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)

Group	Value	95% CI
Methylprednisolone & Prednisone	11
Prednisone	10

Percentage of Participants With Endoscopic and Clinical Remission Primary · 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)

Group	Value	95% CI
Methylprednisolone & Prednisone	31
Prednisone	36

Percentage of Patients With Clinical Remission Secondary · Change from baseline at week 8.

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.

Group	Value	95% CI
Methylprednisolone & Prednisone	36	28 – 44
Prednisone	39	31 – 47

Number of Participants With Adverse Events Secondary · 12 months

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

Group	Value	95% CI
Methylprednisolone & Prednisone	25
Prednisone	21

Number of Participants With Serious Adverse Events Secondary · 12 months

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.

Group	Value	95% CI
Methylprednisolone & Prednisone	1
Prednisone	6

Levels of C-reactive Protein Secondary · Baseline

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

Group	Value	95% CI
Methylprednisolone & Prednisone	8	4 – 16
Prednisone	11	4 – 27

Levels of Serum Albumin Secondary · Baseline

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

Group	Value	95% CI
Methylprednisolone & Prednisone	41	38 – 43
Prednisone	40	36 – 45

Levels of Faecal Calprotectin Secondary · Baseline

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

Group	Value	95% CI
Methylprednisolone & Prednisone	1,230	0,281 – 1,740
Prednisone	1,710	0,561 – 3,330

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Methylprednisolone & Prednisone

Serious: 1/36 (3%)

Deaths: 0/36

Prednisone

Serious: 6/39 (15%)

Deaths: 0/39

Serious adverse events (5 terms)

Reaction	System	Methylprednisolone & Predn…	Prednisone
Ulcerative colitis	Gastrointestinal disorders	—	—
pyrexia	Injury, poisoning and procedural complications	—	—
Malignant neoplasm of the ampulla of Vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
neurogenic tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Epstein Barr virus infection	Infections and infestations	—	—

Other adverse events (19 terms — click to expand)

Reaction	System	Methylprednisolone & Predn…	Prednisone
hyperlipidaemia	Metabolism and nutrition disorders	—	—
Sleeplessness	Nervous system disorders	—	—
Excitability	Nervous system disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Hyperglucemia	Endocrine disorders	—	—
Arterial hypertension	Blood and lymphatic system disorders	—	—
infections	Infections and infestations	—	—
dizziness	Vascular disorders	—	—
Headache	Nervous system disorders	—	—
Heartburn	Gastrointestinal disorders	—	—
Hypertransaminaemia	Metabolism and nutrition disorders	—	—
Arthromyalgia	Musculoskeletal and connective tissue disorders	—	—
Tumours	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Transient diplopia	Eye disorders	—	—
Limb oedema	Vascular disorders	—	—
Hyponatraemia	Blood and lymphatic system disorders	—	—
Acne	Endocrine disorders	—	—
Acute renal dysfunction	Renal and urinary disorders	—	—

Most-reported serious reactions: Ulcerative colitis, pyrexia, Malignant neoplasm of the ampulla of Vater, neurogenic tumor, Epstein Barr virus infection.

Data from ClinicalTrials.gov NCT02921555 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Addition of pulse corticosteroids to oral prednisone in moderately active ulcerative colitis: a randomized, multicentre, open-label study by GETECCU.
   Llaó J, Mañosa M, Martín-Arranz E, Zabana Y, et al · · 2025 · cited 1× · PMID 41258993 · DOI 10.1093/ecco-jcc/jjaf182