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

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ClinicalTrials.gov Identifier: NCT02170714
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Marina Aloi, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment
Pediatric Acute Severe Colitis Other: Clinical and laboratory assessment

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Managing Pediatric Acute Severe Colitis According to the 2011 ECCO-ESPGHAN Guidelines: Efficacy of Infliximab as a Rescue Therapy
Study Start Date : May 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
ASC
Consecutive children hospitalized for an episode of acute ASC, defined as a PUCAI > 65. 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. A follow-up of 2 years for the colectomy risk was evaluated for all patients.
Other: Clinical and laboratory assessment
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 Outcome Measures :
  1. 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 Outcome Measures :
  1. The number of patients with ASC requiring colectomy [ Time Frame: 1,6,12,18,24 months ]
  2. 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.



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive children hospitalized for an episode of ASC, defined as a PUCAI>65
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170714


Locations
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Italy
Department of Pediatrics, Sapienza University of Rome
Rome, Italy
Sponsors and Collaborators
University of Roma La Sapienza

Publications:
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Responsible Party: Marina Aloi, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02170714     History of Changes
Other Study ID Numbers: 16062014
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Marina Aloi, University of Roma La Sapienza:
Acute severe colitis
Children
Infliximab
colectomy
Additional relevant MeSH terms:
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Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents