Summary

for people ages 2-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

Official Title

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Details

This is a multicenter study in pediatric participants aged 2 to 17 years with moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with an endoscopy subscore of greater than or equal to (>=)2. This 54-week study will consist of a 6-week short-term phase and a 48-week long-term phase followed by a study extension (Week 54 to end of study). At Week 58, participants who are eligible will continue receiving golimumab in the study extension. The primary hypothesis is that golimumab is an effective therapy in pediatric UC relative to historical placebo control as assessed by clinical remission based on Mayo score. Safety will be monitored throughout the study.

Keywords

Colitis, Ulcerative Colitis Ulcer Infliximab Antibodies, Monoclonal Golimumab

Eligibility

You can join if…

Open to people ages 2-17

  • Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency(that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis [UC]) OR required more than 3 courses of corticosteroids in the past year
  • Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12[endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist],inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (>=2)
  • If receiving parenteral or enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0
  • No history of latent or active tuberculosis prior to screening
  • Acceptable evidence of immunity to measles, mumps, rubella, and varicella

You CAN'T join if...

  • History of liver or renal insufficiency; significant cardiac, vascular, pulmonary,gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric(including suicidality), or metabolic disturbances
  • History of malignancy or macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
  • Have UC limited to the rectum only or to <20 percent (%) of the colon
  • Presence of a stoma
  • Presence or history of a fistula
  • Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor(TNF-alpha) therapy per local prescribing information

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • Rocky Mountain Pediatric Gastroenterology not yet accepting patients
    Lone Tree Colorado 80124 United States
  • Children's Hospital Colorado and University of Colorado not yet accepting patients
    Aurora Colorado 80045 United States
  • DHAT Research Institute not yet accepting patients
    Plano Texas 75093 United States
  • Children's Medical Center of Dallas not yet accepting patients
    Dallas Texas 75207 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT03596645
Phase
Phase 3
Study Type
Interventional
Last Updated
July 13, 2018