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

Last updated: March 18, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Golimumab

Infliximab

Clinical Study ID

NCT03596645
CR108499
2017-004496-31
2023-507142-83-00
CNTO148UCO3003
  • Ages 2-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must either be currently receiving treatment with, or have a history of havingfailed to respond to, or have a medical contraindication to at least 1 of thefollowing therapies: oral or intravenous corticosteroids, 6-mercaptopurine,methotrexate or azathioprine OR must either have or have had a history ofcorticosteroid dependency (that is an inability to successfully tapercorticosteroids without a return of the symptoms of ulcerative colitis [UC]) ORrequired 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 orequal to (>=2)

  • If receiving enteral nutrition, must have been on a stable regimen for at least 2weeks prior to the first administration of study intervention at Week 0.Participants who receive parenteral nutrition are not permitted to enroll in thetrial

  • No history of latent or active tuberculosis prior to screening

  • Must be up to date with all immunizations (that is, measles, mumps, rubella, andvaricella) in agreement with current local immunization guidelines forimmunosuppressed participants before Week 0

Exclusion

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 hemophagocyticlymphohistiocytosis

  • 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 necrosisfactor (TNF-alpha) therapy per local prescribing information

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Golimumab
Phase: 3
Study Start date:
October 29, 2018
Estimated Completion Date:
February 20, 2027

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussel, 1200
    Belgium

    Site Not Available

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussel, 1020
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussels, 1020
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Brussels 2800866, 1200
    Belgium

    Site Not Available

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussels 2800866, 1020
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • UZ Brussel

    Jette, 1090
    Belgium

    Site Not Available

  • UZ Brussel

    Jette 2794914, 1090
    Belgium

    Site Not Available

  • MK Blumenau Pesquisa Clínica

    Blumenau, 89010-506
    Brazil

    Site Not Available

  • MK Blumenau Pesquisa Clínica

    Blumenau 3469968, 89010-506
    Brazil

    Site Not Available

  • Hospital Pequeno Principe

    Curitiba, 80250-060
    Brazil

    Site Not Available

  • Hospital Pequeno Principe

    Curitiba 3464975, 80250-060
    Brazil

    Site Not Available

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035-074
    Brazil

    Site Not Available

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre 3452925, 90035-074
    Brazil

    Site Not Available

  • BR Trials

    Sao Paulo, 01236030
    Brazil

    Site Not Available

  • BR Trials

    São Paulo, 01236030
    Brazil

    Site Not Available

  • BR Trials

    São Paulo 3448439, 01236030
    Brazil

    Site Not Available

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux, 33000
    France

    Site Not Available

  • Hôpital Pellegrin CHU Bordeaux

    Bordeaux, 33000
    France

    Site Not Available

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux 3031582, 33000
    France

    Site Not Available

  • Hopital Femme Mère Enfant

    Bron, 69677
    France

    Site Not Available

  • Hôpital Necker

    Paris, 75015
    France

    Site Not Available

  • Hôpital Necker

    Paris 2988507, 75015
    France

    Site Not Available

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 91031
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem 281184, 91031
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah Tikva, 4920235
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah Tikva 293918, 4920235
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan 293788, 52621
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Rishon LeZiyyon, 70300
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Rishon LeZiyyon 293703, 70300
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Rishon-Le-Zion, 70300
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, 6997801
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv 293397, 6997801
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel-Aviv, 6997801
    Israel

    Site Not Available

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna, 40133
    Italy

    Site Not Available

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna 3181928, 40133
    Italy

    Site Not Available

  • ASST Spedali Civili Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • AOU Meyer

    Firenze, 50139
    Italy

    Site Not Available

  • AOU Meyer

    Florence, 50139
    Italy

    Site Not Available

  • AOU Meyer

    Florence 3176959, 50139
    Italy

    Site Not Available

  • AOU Policlinico G.Martino

    Messina, 98124
    Italy

    Site Not Available

  • AOU Policlinico G.Martino

    Messina 2524170, 98124
    Italy

    Site Not Available

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Site Not Available

  • AOU Policlinico Umberto I

    Roma 8957247, 00161
    Italy

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma 8957247, 00165
    Italy

    Site Not Available

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Casa Sollievo della Sofferenza, IRCCS

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo 3168234, 71013
    Italy

    Site Not Available

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste, 34137
    Italy

    Site Not Available

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste 3165185, 34137
    Italy

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Emma Children's Hospital Academic Medical Center

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Emma Children's Hospital Academic Medical Center

    Amsterdam 2759794, 1105 AZ
    Netherlands

    Site Not Available

  • Radboudumc Amalia Children's Hospital

    Nijmegen, 6500 HB
    Netherlands

    Site Not Available

  • Isala Kliniek

    Zwolle, 8000 GK
    Netherlands

    Site Not Available

  • Isala Kliniek

    Zwolle 2743477, 8000 GK
    Netherlands

    Site Not Available

  • Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

    Bydgoszcz, 85 094
    Poland

    Site Not Available

  • Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

    Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

    Bydgoszcz 3102014, 85 094
    Poland

    Site Not Available

  • Szpital im. M. Kopernika

    Gdansk, 80 803
    Poland

    Site Not Available

  • Szpital im. M. Kopernika

    Gdansk 3099434, 80 803
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30 663
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow 3094802, 30 663
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Kraków, 30-663
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego

    Olsztyn, 10 561
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego

    Olsztyn, 10-561
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego

    Olsztyn 763166, 10 561
    Poland

    Site Not Available

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Site Not Available

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302
    Poland

    Site Not Available

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów 759734, 35-302
    Poland

    Site Not Available

  • Centrum Zdrowia Matki Dziecka i Mlodziezy

    Warsaw, 00 635
    Poland

    Site Not Available

  • Szpital Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730
    Poland

    Site Not Available

  • Centrum Zdrowia Matki Dziecka i Mlodziezy

    Warsaw 756135, 00 635
    Poland

    Site Not Available

  • Szpital Pomnik Centrum Zdrowia Dziecka

    Warsaw 756135, 04-730
    Poland

    Site Not Available

  • Centrum Zdrowia Matki Dziecka i Mlodziezy

    Warszawa, 00 635
    Poland

    Site Not Available

  • Centrum Zdrowia Matki, Dziecka i Młodzieży

    Warszawa, 00-635
    Poland

    Site Not Available

  • Szpital Pomnik Centrum Zdrowia Dziecka

    Warszawa, 04-730
    Poland

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    South Korea

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu 1835329, 41404
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Hosp. Univ. de Cruces

    Barakaldo, 48902
    Spain

    Site Not Available

  • Hosp. Univ. de Cruces

    Barakaldo 3109453, 48902
    Spain

    Site Not Available

  • Hosp. Sant Joan de Deu

    Barcelona, 08950
    Spain

    Site Not Available

  • Hosp. Sant Joan de Deu

    Barcelona 3128760, 08950
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28036
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Marañon

    Madrid, 28036
    Spain

    Site Not Available

  • Hosp. Infantil Univ. Nino Jesus

    Madrid, 28009
    Spain

    Site Not Available

  • Hosp. Infantil Univ. Niño Jesus

    Madrid, 28009
    Spain

    Site Not Available

  • Hosp. Univ. 12 De Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid 3117735, 28036
    Spain

    Site Not Available

  • Hosp. Infantil Univ. Nino Jesus

    Madrid 3117735, 28009
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hosp Regional Univ de Malaga

    Málaga, 29011
    Spain

    Site Not Available

  • Hosp. Regional Univ. de Malaga

    Málaga, 29011
    Spain

    Site Not Available

  • Hosp Regional Univ de Malaga

    Málaga 2514256, 29011
    Spain

    Site Not Available

  • Hosp. Sant Joan de Deu

    Sant Cugat Del Vallés, 08173
    Spain

    Site Not Available

  • Hosp. Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hosp. Virgen Del Rocio

    Seville, 41013
    Spain

    Site Not Available

  • Hosp. Virgen Del Rocio

    Seville 2510911, 41013
    Spain

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 112
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital- Linkou

    Taoyuan, 33305
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital- Linkou

    Taoyuan 6696918, 33305
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital- Linkou

    Taoyuan City, 33305
    Taiwan

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Children's Hospital Colorado and University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Rocky Mountain Pediatric Gastroenterology

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • Children's Hospital Colorado and University of Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Rocky Mountain Pediatric Gastroenterology

    Lone Tree 5429208, Colorado 5417618 80124
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford 4835797, Connecticut 4831725 06106
    United States

    Site Not Available

  • Nemours DuPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Nemours DuPont Hospital for Children

    Wilmington 4145381, Delaware 4142224 19803
    United States

    Site Not Available

  • Children's Center for Digestive Health Care

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Children's Center for Digestive Health Care

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • GI For Kids

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • GI For Kids

    Knoxville 4634946, Tennessee 4662168 37922
    United States

    Site Not Available

  • Children's Medical Center of Dallas

    Dallas, Texas 75207
    United States

    Site Not Available

  • Cook Childrens Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • DHAT Research Institute

    Garland, Texas 75044
    United States

    Site Not Available

  • DHAT Research Institute

    Plano, Texas 75093
    United States

    Site Not Available

  • Children's Medical Center of Dallas

    Dallas 4684888, Texas 4736286 75207
    United States

    Site Not Available

  • Cook Childrens Medical Center

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • DHAT Research Institute

    Garland 4693003, Texas 4736286 75044
    United States

    Site Not Available

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