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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion 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 - Acceptable evidence of immunity to measles, mumps, rubella, and varicella

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03596645
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Brazil, France, Israel, Italy, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Study Website: View Trial Website
Additional 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.

Arms & Interventions

Arms

Experimental: Group 1: Golimumab

Participants will receive subcutaneous (SC) golimumab through Week 50. 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.

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.

Interventions

Drug: - 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94158

Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado and University of Colorado

Aurora, Colorado, 80045

Lone Tree, Colorado

Status

Recruiting

Address

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, 80124

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Recruiting

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Nemours DuPont Hospital for Children, Wilmington, Delaware

Status

Recruiting

Address

Nemours DuPont Hospital for Children

Wilmington, Delaware, 19803

Atlanta, Georgia

Status

Recruiting

Address

Children's Center for Digestive Health Care

Atlanta, Georgia, 30342

Boston Children's Hospital, Boston, Massachusetts

Status

Withdrawn

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Chapel Hill, North Carolina

Status

Withdrawn

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Digestive Disease Specialists Inc, Oklahoma City, Oklahoma

Status

Not yet recruiting

Address

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112

Medical University of South Carolina, Charleston, South Carolina

Status

Withdrawn

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

GI For Kids, Knoxville, Tennessee

Status

Not yet recruiting

Address

GI For Kids

Knoxville, Tennessee, 37916

Children's Medical Center of Dallas, Dallas, Texas

Status

Recruiting

Address

Children's Medical Center of Dallas

Dallas, Texas, 75207

Cook Childrens Medical Center, Fort Worth, Texas

Status

Recruiting

Address

Cook Childrens Medical Center

Fort Worth, Texas, 76104

DHAT Research Institute, Garland, Texas

Status

Recruiting

Address

DHAT Research Institute

Garland, Texas, 75044

International Sites

Brussel, Belgium

Status

Recruiting

Address

Universitair Kinderziekenhuis Koningin Fabiola

Brussel, , 1020

Cliniques Universitaires Saint-Luc, Brussel, Belgium

Status

Recruiting

Address

Cliniques Universitaires Saint-Luc

Brussel, , 1200

UZ Brussel, Jette, Belgium

Status

Recruiting

Address

UZ Brussel

Jette, , 1090

MK Blumenau Pesquisa Clínica, Blumenau, Brazil

Status

Recruiting

Address

MK Blumenau Pesquisa Clínica

Blumenau, , 89010-506

Hospital Pequeno Principe, Curitiba, Brazil

Status

Recruiting

Address

Hospital Pequeno Principe

Curitiba, , 80250-060

Porto Alegre, Brazil

Status

Recruiting

Address

Hospital da Crianca Santo Antonio de Porto Alegre

Porto Alegre, , 92020-430

Hôpital Pellegrin CHU Bordeaux, Bordeaux, France

Status

Recruiting

Address

Hôpital Pellegrin CHU Bordeaux

Bordeaux, , 33000

Hopital Femme Mère Enfant, Bron, France

Status

Withdrawn

Address

Hopital Femme Mère Enfant

Bron, , 69677

Hôpital Necker, Paris, France

Status

Recruiting

Address

Hôpital Necker

Paris, , 75015

Rambam Medical Center, Haifa, Israel

Status

Recruiting

Address

Rambam Medical Center

Haifa, , 3109601

Shaare Zedek Medical Center, Jerusalem, Israel

Status

Recruiting

Address

Shaare Zedek Medical Center

Jerusalem, , 91031

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, , 52621

Assaf Harofeh Medical Center, Rishon-Le-Zion, Israel

Status

Recruiting

Address

Assaf Harofeh Medical Center

Rishon-Le-Zion, , 70300

Sourasky Medical Center, Tel-Aviv, Israel

Status

Recruiting

Address

Sourasky Medical Center

Tel-Aviv, , 6997801

Bologna, Italy

Status

Recruiting

Address

Azienda USL di Bologna - Ospedale Maggiore

Bologna, , 40133

AOU Policlinico G.Martino, Messina, Italy

Status

Recruiting

Address

AOU Policlinico G.Martino

Messina, , 98124

AOU Policlinico Umberto I, Roma, Italy

Status

Recruiting

Address

AOU Policlinico Umberto I

Roma, , 00161

IRCCS Ospedale Pediatrico Bambino Gesu, Roma, Italy

Status

Recruiting

Address

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, , 00165

IRCCS Materno Infantile Burlo Garofolo, Trieste, Italy

Status

Recruiting

Address

IRCCS Materno Infantile Burlo Garofolo

Trieste, , 34137

Daegu, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Chilgok Hospital

Daegu, , 41404

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital, Yonsei University Health System

Seoul, , 03722

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 5505

Amsterdam, Netherlands

Status

Not yet recruiting

Address

Emma Children's Hospital Academic Medical Center

Amsterdam, , 1105 AZ

Radboudumc Amalia Children's Hospital, Nijmegen, Netherlands

Status

Withdrawn

Address

Radboudumc Amalia Children's Hospital

Nijmegen, , 6500 HB

Isala Kliniek, Zwolle, Netherlands

Status

Recruiting

Address

Isala Kliniek

Zwolle, , 8000 GK

Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

Bydgoszcz, , 85-094

Szpital im. M. Kopernika, Gdansk, Poland

Status

Recruiting

Address

Szpital im. M. Kopernika

Gdansk, , 80-803

Krakow, Poland

Status

Recruiting

Address

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, , 30-663

Olsztyn, Poland

Status

Completed

Address

Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego

Olsztyn, , 10-561

Gabinet Lekarski Bartosz Korczowski, Rzeszow, Poland

Status

Not yet recruiting

Address

Gabinet Lekarski Bartosz Korczowski

Rzeszow, , 35-302

Warszawa, Poland

Status

Recruiting

Address

Centrum Zdrowia Matki, Dziecka i Młodzieży

Warszawa, , 00-635

Szpital Pomnik Centrum Zdrowia Dziecka, Warszawa, Poland

Status

Recruiting

Address

Szpital Pomnik Centrum Zdrowia Dziecka

Warszawa, , 04-730

Hosp. Univ. de Cruces, Barakaldo, Spain

Status

Recruiting

Address

Hosp. Univ. de Cruces

Barakaldo, , 48902

Hosp. Sant Joan de Deu, Barcelona, Spain

Status

Recruiting

Address

Hosp. Sant Joan de Deu

Barcelona, , 08950

Hosp. Infantil Univ. Niño Jesus, Madrid, Spain

Status

Recruiting

Address

Hosp. Infantil Univ. Niño Jesus

Madrid, , 28009

Hosp. Gral. Univ. Gregorio Marañon, Madrid, Spain

Status

Recruiting

Address

Hosp. Gral. Univ. Gregorio Marañon

Madrid, , 28036

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Regional Univ. de Malaga, Málaga, Spain

Status

Recruiting

Address

Hosp. Regional Univ. de Malaga

Málaga, , 29011

Hosp. Virgen Del Rocio, Sevilla, Spain

Status

Recruiting

Address

Hosp. Virgen Del Rocio

Sevilla, , 41013

National Taiwan University Hospital, Taipei, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei, , 100

Taipei Veterans General Hospital, Taipei, Taiwan

Status

Recruiting

Address

Taipei Veterans General Hospital

Taipei, , 112

Chang Gung Memorial Hospital- Linkou, Taoyuan City, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital- Linkou

Taoyuan City, , 33305

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