Clinical trial NCT02170714: Efficacy of Infliximab as a Rescue Therapy in Pediatric Acute Severe Colitis
Official title: Managing Pediatric Acute Severe Colitis According to the 2011 ECCO-ESPGHAN Guidelines: Efficacy of Infliximab as a Rescue Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Acute Severe Colitis
Keywords: Acute severe colitis
Children
Infliximab
colectomy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive children hospitalized for an episode of ASC, defined as a PUCAI\>65

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of patients with ASC treated with IFX requiring colectomy
timeFrame: 24 months
Secondary outcomes:
measure: The number of patients with ASC requiring colectomy
timeFrame: 1,6,12,18,24 months
measure: To identify clinical predictive factors at the diagnosis of ASC of surgical need at follow-up
timeFrame: First day of the hospitalization
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Pediatrics, Sapienza University of Rome
Study officials:
References:
citation: Turner D, Travis SP, Griffiths AM, Ruemmele FM, Levine A, Benchimol EI, Dubinsky M, Alex G, Baldassano RN, Langer JC, Shamberger R, Hyams JS, Cucchiara S, Bousvaros A, Escher JC, Markowitz J, Wilson DC, van Assche G, Russell RK; European Crohn's and Colitis Organization; Porto IBD Working Group, European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Consensus for managing acute severe ulcerative colitis in children: a systematic review and joint statement from ECCO, ESPGHAN, and the Porto IBD Working Group of ESPGHAN. Am J Gastroenterol. 2011 Apr;106(4):574-88. doi: 10.1038/ajg.2010.481. Epub 2011 Jan 11.
citation: Turner D, Griffiths AM. Acute severe ulcerative colitis in children: a systematic review. Inflamm Bowel Dis. 2011 Jan;17(1):440-9. doi: 10.1002/ibd.21383.
citation: Turner D, Mack D, Leleiko N, Walters TD, Uusoue K, Leach ST, Day AS, Crandall W, Silverberg MS, Markowitz J, Otley AR, Keljo D, Mamula P, Kugathasan S, Hyams J, Griffiths AM. Severe pediatric ulcerative colitis: a prospective multicenter study of outcomes and predictors of response. Gastroenterology. 2010 Jun;138(7):2282-91. doi: 10.1053/j.gastro.2010.02.047. Epub 2010 Feb 26.