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

NCT03596645 | Active Not Recruiting Phase 3 Results FDA Drug

• 4 other identifiers: CR108499CNTO148UCO30032017-004496-312023-507142-83-00
• Study Type: interventional
• Target: 84
• Locations: 11 countries
• Sites: 58

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score

  Percentage of participants with clinical remission at Week 6 as assessed by the Mayo score was reported. Clinical remission was defined as a Mayo score of less than or equal to (\<=) 2 point, with no individual sub-score greater than (\>) 1. The Mayo score was sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.

  Week 6

Secondary Outcomes (9)

• Percentage of Participants With Symptomatic Remission at Week 54

  Week 54

• Percentage of Participants With Clinical Remission at Week 54 as Assessed by the Mayo Score

  Week 54

• Percentage of Participants With Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score

  Week 54

• Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score

  Week 6

• Percentage of Participants With Clinical Response at Week 6 as Assessed by the Mayo Score

  Week 6

Study Arms (2)

Group 1: Golimumab

EXPERIMENTAL

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.

Drug: Golimumab

Group 2: Infliximab

EXPERIMENTAL

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.

Drug: Infliximab

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.

Group 1: Golimumab

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.

Group 2: Infliximab

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (58)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Children's Hospital Colorado and University of Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, 80124, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Nemours DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's Center for Digestive Health Care

Atlanta, Georgia, 30342, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

GI For Kids

Knoxville, Tennessee, 37922, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75207, United States

Location

Cook Childrens Medical Center

Fort Worth, Texas, 76104, United States

Location

DHAT Research Institute

Garland, Texas, 75044, United States

Location

Universitair Kinderziekenhuis Koningin Fabiola

Brussels, 1020, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

MK Blumenau Pesquisa Clínica

Blumenau, 89010-506, Brazil

Location

Hospital Pequeno Principe

Curitiba, 80250-060, Brazil

Location

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90035-074, Brazil

Location

BR Trials

São Paulo, 01236030, Brazil

Location

Hopital Pellegrin CHU Bordeaux

Bordeaux, 33000, France

Location

Hôpital Necker

Paris, 75015, France

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Schneider Children's Medical Center

Petah Tikva, 4920235, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Assaf Harofeh Medical Center

Rishon LeZiyyon, 70300, Israel

Location

Sourasky Medical Center

Tel Aviv, 6997801, Israel

Location

Azienda USL di Bologna - Ospedale Maggiore

Bologna, 40133, Italy

Location

AOU Meyer

Florence, 50139, Italy

Location

AOU Policlinico G.Martino

Messina, 98124, Italy

Location

AOU Policlinico Umberto I

Roma, 00161, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

Location

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, 71013, Italy

Location

IRCCS Materno Infantile Burlo Garofolo

Trieste, 34137, Italy

Location

Emma Children's Hospital Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Isala Kliniek

Zwolle, 8000 GK, Netherlands

Location

Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

Bydgoszcz, 85 094, Poland

Location

Szpital im. M. Kopernika

Gdansk, 80 803, Poland

Location

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, 30 663, Poland

Location

Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego

Olsztyn, 10 561, Poland

Location

Korczowski Bartosz Gabinet Lekarski

Rzeszów, 35-302, Poland

Location

Centrum Zdrowia Matki Dziecka i Mlodziezy

Warsaw, 00 635, Poland

Location

Szpital Pomnik Centrum Zdrowia Dziecka

Warsaw, 04-730, Poland

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hosp. Univ. de Cruces

Barakaldo, 48902, Spain

Location

Hosp. Sant Joan de Deu

Barcelona, 08950, Spain

Location

Hosp. Infantil Univ. Nino Jesus

Madrid, 28009, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28036, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29011, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Chang Gung Memorial Hospital- Linkou

Taoyuan, 33305, Taiwan

Location

Related Publications (1)

• Turner D, Lomax KG, Veereman G, Griffiths AM, Kierkus J, Kang B, Berezny K, Padgett L, Mao G, Zitser Y, Strauss RS, Verhoeven J, Adedokun OJ, Hyams JS. Efficacy, Safety, and Pharmacokinetics of Golimumab in Children with Moderately-To-Severely Active Ulcerative Colitis: Results from the PURSUIT 2 Study. Inflamm Bowel Dis. 2026 Jan 8:izaf322. doi: 10.1093/ibd/izaf322. Online ahead of print.

  PMID: 41503939 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab; Infliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: October 29, 2018
• Primary Completion: November 21, 2023
• Study Completion (Estimated): February 20, 2027
• Last Updated: April 13, 2026
• Results First Posted: November 14, 2025

Record last verified: 2026-04

Locations

PL (7); KR (5); NL (2); BE (3); TW (3); FR (2); IL (6); ES (7); IT (7); US (12); BR (4)