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

NCT ID: NCT03596645

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2027-02-20

Brief 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.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: 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.

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 After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their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.

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: 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 After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their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.

Interventions

Golimumab

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

University of California San Francisco

San Francisco, California, United States

Children's Hospital Colorado and University of Colorado

Aurora, Colorado, United States

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Nemours DuPont Hospital for Children

Wilmington, Delaware, United States

Children's Center for Digestive Health Care

Atlanta, Georgia, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Medical Center

New York, New York, United States

GI For Kids

Knoxville, Tennessee, United States

Children's Medical Center of Dallas

Dallas, Texas, United States

Cook Childrens Medical Center

Fort Worth, Texas, United States

DHAT Research Institute

Garland, Texas, United States

Universitair Kinderziekenhuis Koningin Fabiola

Brussels, , Belgium

Cliniques Universitaires Saint Luc

Brussels, , Belgium

UZ Brussel

Jette, , Belgium

MK Blumenau Pesquisa Clínica

Blumenau, , Brazil

Hospital Pequeno Principe

Curitiba, , Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

BR Trials

São Paulo, , Brazil

Hopital Pellegrin CHU Bordeaux

Bordeaux, , France

Hôpital Necker

Paris, , France

Rambam Medical Center

Haifa, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Schneider Children's Medical Center

Petah Tikva, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Assaf Harofeh Medical Center

Rishon LeZiyyon, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Azienda USL di Bologna - Ospedale Maggiore

Bologna, , Italy

AOU Meyer

Florence, , Italy

AOU Policlinico G.Martino

Messina, , Italy

AOU Policlinico Umberto I

Roma, , Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, , Italy

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, , Italy

IRCCS Materno Infantile Burlo Garofolo

Trieste, , Italy

Emma Children's Hospital Academic Medical Center

Amsterdam, , Netherlands

Isala Kliniek

Zwolle, , Netherlands

Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

Bydgoszcz, , Poland

Szpital im. M. Kopernika

Gdansk, , Poland

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, , Poland

Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego

Olsztyn, , Poland

Korczowski Bartosz Gabinet Lekarski

Rzeszów, , Poland

Centrum Zdrowia Matki Dziecka i Mlodziezy

Warsaw, , Poland

Szpital Pomnik Centrum Zdrowia Dziecka

Warsaw, , Poland

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Hosp. Univ. de Cruces

Barakaldo, , Spain

Hosp. Sant Joan de Deu

Barcelona, , Spain

Hosp. Infantil Univ. Nino Jesus

Madrid, , Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp Regional Univ de Malaga

Málaga, , Spain

Hosp. Virgen Del Rocio

Seville, , Spain

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital- Linkou

Taoyuan, , Taiwan

Countries

United States; Belgium; Brazil; France; Israel; Italy; Netherlands; Poland; South Korea; Spain; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNTO148UCO3003

Identifier Type: OTHER

Identifier Source: secondary_id

2017-004496-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-507142-83-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108499

Identifier Type: -

Identifier Source: org_study_id