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



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


Colitis, Ulcerative, Colitis, Ulcerative Colitis, Ulcer, Infliximab, Golimumab


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 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. Participants who receive parenteral nutrition are not permitted to enroll in the trial
  • No history of latent or active tuberculosis prior to screening
  • Must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before Week 0

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 or hemophagocytic lymphohistiocytosis
  • 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


  • UCSF
    San Francisco California 94158 United States
  • Rocky Mountain Pediatric Gastroenterology
    Lone Tree Colorado 80124 United States


in progress, not accepting new patients
Start Date
Completion Date
Janssen Research & Development, LLC
Phase 3 research study
Study Type
About 84 people participating
Last Updated