A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in San Francisco, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03596645
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    Participants receive subcutaneous (SC) golimumab through Week 50, where doses will be based on body surface area. After the Week 54 evaluations, at the discretion of investigator, participants benefiting from continued SC golimumab will continue to receive SC golimumab in the extension until end of study.
  • Infliximab — DRUG
    Participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician.

Study Details

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.

Key Dates

Start date
Oct 29, 2018
Status verified
Jun 2026
Primary completion
Nov 21, 2023
Completion
Feb 1, 2027

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Golimumab
    Participants will receive subcutaneous (SC) golimumab through Week 50. Doses will be based on body surface area. Following the Week 54 evaluations (end of main pivotal study) participants who are benefiting from golimumab at the discretion of the investigator may continue to receive SC golimumab in an extension period until end of study.
  • Experimental: Group 2: Infliximab
    Participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician.

Primary Outcome Measure

Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score [ Time Frame: Week 6 ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158-
Children's Hospital Colorado and University of ColoradoAuroraColorado80045-
Rocky Mountain Pediatric GastroenterologyLone TreeColorado80124-
Connecticut Children's Medical CenterHartfordConnecticut06106-
Nemours DuPont Hospital for ChildrenWilmingtonDelaware19803-
Children's Center for Digestive Health CareAtlantaGeorgia30342-
Mayo ClinicRochesterMinnesota55905-
Columbia University Medical CenterNew YorkNew York10032-
GI For KidsKnoxvilleTennessee37922-
Children's Medical Center of DallasDallasTexas75207-
Cook Childrens Medical CenterFort WorthTexas76104-
DHAT Research InstituteGarlandTexas75044-

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CAChildren's Hospital Colorado and University of Colorado· Aurora, CORocky Mountain Pediatric Gastroenterology· Lone Tree, COConnecticut Children's Medical Center· Hartford, CTNemours DuPont Hospital for Children· Wilmington, DEChildren's Center for Digestive Health Care· Atlanta, GA

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