Predicting Response to Standardized Pediatric Colitis Therapy

Summary

This is a multi-center, open-label study to determine the safety and effectiveness (how well it works) of two standardized treatments called "mesalamine" (Pentasa®) and "prednisone" in children with newly diagnosed Ulcerative Colitis (UC). Standardized treatments are types of treatments agreed upon and used by many qualified doctors. The medications being used in this study are considered "standard of care". Currently the ways in which these medicines are used (doses, frequency of dosing) may vary from site to site. This study will determine response to a standardized way of giving these medicines.

This study will also identify biomarkers for ulcerative colitis. Biomarkers are things that doctors can find in blood, stool, or bowel tissue that indicate how much inflammation there is in the bowel, how the inflammation is produced, and whether the inflammation is responding to treatment. Collecting response and remission (free of symptoms) information on these standardized treatments and the "biomarkers" can possibly help doctors create a model, or plan to know which children with UC may respond quickly, or which children may develop complications.

Conditions

• Ulcerative Colitis

Interventions

DRUG

Mesalazine

Mesalazine (Pentasa) comes in 500mg capsules, and doses will need to be rounded to the nearest 500mg increment, with a maximum dose of 76 mg/kg/day. The average dose for the pediatric population will be approximately 70 mg/kg/day. Patients will be allowed to escalate to the final dose over 4 days to minimize side-effects such as headache.

DRUG

IV Corticosteroid

Treatment with IV Corticosteroid

DRUG

Oral Corticosteroids

Treatment with oral corticosteroids

OTHER

Additional Therapies

Anti-TNFα, Calcineurin inhibitor, Immunomodulator

PROCEDURE

Colectomy

Colectomy

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Connecticut Children's Medical Center

  lead OTHER

Principal Investigators

• Jeffrey Hyams, MD · Connecticut Children's Medical Center

• Lee Denson, MD · Children's Hospital Medical Center, Cincinnati

• Sonia Davis, DrPH · Collaborative Studies Coordinating Center - UNC-CH

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-10

Primary Completion

2018-04-30

Completion

2018-04-30

Countries

• United States
• Canada

Study Locations