Completed

NCT Number: NCT02170714

Efficacy of Infliximab as a Rescue Therapy in Pediatric Acute Severe Colitis

Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a second line therapy. This study was performed in consecutively observed pediatric patients with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)- European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN) guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical predictors of poor outcome.

Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All patients were treated according to the above mentioned guidelines for ASC and received intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy rate and the efficacy of IFX in avoiding colectomy were evaluated.

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Key information

Conditions

Pediatric Acute Severe Colitis

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics, Sapienza University of Rome

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of ASC
Confirmed diagnosis of ulcerative colitis (UC)
Age 1-18 years

Exclusion criteria

Not confirmed diagnosis of UC
Contraindications for infliximab therapy

Treatment and study plan

Clinical and laboratory assessment

Other

Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) were recorded at admission and at day 3 and 5. All patients were treated according to the 2011 ECCO-ESPGHAN guidelines for ASC: all patients received intravenous (iv) corticosteroids (methylprednisolone 1.5-2 mg/Kg/day) for 5 days. Patients not responding to corticosteroids (i.e. PUCAI>65 at day 5) started Infliximab (IFX, 5 mg/Kg 0,2,6 then every 8 weeks) as second-line therapy. All therapies were decided at the discretion of the referral gastroenterologist and recorded on standardized case report forms

Primary outcomes

The number of patients with ASC treated with IFX requiring colectomy

Time frame: 24 months

The surgical need will be evaluated in the group of patients treated with IFX during a 24-month follow-up

Secondary outcomes

The number of patients with ASC requiring colectomy

Time frame: 1,6,12,18,24 months
To identify clinical predictive factors at the diagnosis of ASC of surgical need at follow-up

Time frame: First day of the hospitalization

Clinical variables at the diagnosis of ASC (i.e. duration of the disease before the episode of SC, past and ongoing therapies, age, family history, Perinuclear Anti-Neutrophil Cytoplasmic Antibodies - pANCA, PUCAI) were evaluated in the group of children needed colectomy at follow-up versus those not requiring surgery.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Managing Pediatric Acute Severe Colitis According to the 2011 ECCO-ESPGHAN Guidelines: Efficacy of Infliximab as a Rescue Therapy

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2014
First posted: Jun 23, 2014
Registry last updated: Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.