Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Golimumab
Infliximab
Clinical Study ID
Ages 2-17 All Genders
Study Summary
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
Connect with a study center
Cliniques Universitaires Saint-Luc
Brussel, 1200
BelgiumSite Not Available
Universitair Kinderziekenhuis Koningin Fabiola
Brussel, 1020
BelgiumSite Not Available
Cliniques Universitaires Saint Luc
Brussels, 1200
BelgiumSite Not Available
Universitair Kinderziekenhuis Koningin Fabiola
Brussels, 1020
BelgiumSite Not Available
Cliniques Universitaires Saint Luc
Brussels 2800866, 1200
BelgiumSite Not Available
Universitair Kinderziekenhuis Koningin Fabiola
Brussels 2800866, 1020
BelgiumSite Not Available
Cliniques Universitaires Saint Luc
Bruxelles, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
UZ Brussel
Jette, 1090
BelgiumSite Not Available
UZ Brussel
Jette 2794914, 1090
BelgiumSite Not Available
MK Blumenau Pesquisa Clínica
Blumenau, 89010-506
BrazilSite Not Available
MK Blumenau Pesquisa Clínica
Blumenau 3469968, 89010-506
BrazilSite Not Available
Hospital Pequeno Principe
Curitiba, 80250-060
BrazilSite Not Available
Hospital Pequeno Principe
Curitiba 3464975, 80250-060
BrazilSite Not Available
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-074
BrazilSite Not Available
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre 3452925, 90035-074
BrazilSite Not Available
BR Trials
Sao Paulo, 01236030
BrazilSite Not Available
BR Trials
São Paulo, 01236030
BrazilSite Not Available
BR Trials
São Paulo 3448439, 01236030
BrazilSite Not Available
Hopital Pellegrin CHU Bordeaux
Bordeaux, 33000
FranceSite Not Available
Hôpital Pellegrin CHU Bordeaux
Bordeaux, 33000
FranceSite Not Available
Hopital Pellegrin CHU Bordeaux
Bordeaux 3031582, 33000
FranceSite Not Available
Hopital Femme Mère Enfant
Bron, 69677
FranceSite Not Available
Hôpital Necker
Paris, 75015
FranceSite Not Available
Hôpital Necker
Paris 2988507, 75015
FranceSite Not Available
Rambam Medical Center
Haifa, 3109601
IsraelSite Not Available
Rambam Medical Center
Haifa 294801, 3109601
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, 91031
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem 281184, 91031
IsraelSite Not Available
Schneider Children's Medical Center
Petah Tikva, 4920235
IsraelSite Not Available
Schneider Children's Medical Center
Petah Tikva 293918, 4920235
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 52621
IsraelSite Not Available
Sheba Medical Center
Ramat Gan 293788, 52621
IsraelSite Not Available
Assaf Harofeh Medical Center
Rishon LeZiyyon, 70300
IsraelSite Not Available
Assaf Harofeh Medical Center
Rishon LeZiyyon 293703, 70300
IsraelSite Not Available
Assaf Harofeh Medical Center
Rishon-Le-Zion, 70300
IsraelSite Not Available
Sourasky Medical Center
Tel Aviv, 6997801
IsraelSite Not Available
Sourasky Medical Center
Tel Aviv 293397, 6997801
IsraelSite Not Available
Sourasky Medical Center
Tel-Aviv, 6997801
IsraelSite Not Available
Azienda USL di Bologna - Ospedale Maggiore
Bologna, 40133
ItalySite Not Available
Azienda USL di Bologna - Ospedale Maggiore
Bologna 3181928, 40133
ItalySite Not Available
ASST Spedali Civili Brescia
Brescia, 25123
ItalySite Not Available
AOU Meyer
Firenze, 50139
ItalySite Not Available
AOU Meyer
Florence, 50139
ItalySite Not Available
AOU Meyer
Florence 3176959, 50139
ItalySite Not Available
AOU Policlinico G.Martino
Messina, 98124
ItalySite Not Available
AOU Policlinico G.Martino
Messina 2524170, 98124
ItalySite Not Available
AOU Policlinico Umberto I
Roma, 00161
ItalySite Not Available
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalySite Not Available
AOU Policlinico Umberto I
Roma 8957247, 00161
ItalySite Not Available
IRCCS Ospedale Pediatrico Bambino Gesu
Roma 8957247, 00165
ItalySite Not Available
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013
ItalySite Not Available
Casa Sollievo della Sofferenza, IRCCS
San Giovanni Rotondo, 71013
ItalySite Not Available
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo 3168234, 71013
ItalySite Not Available
IRCCS Materno Infantile Burlo Garofolo
Trieste, 34137
ItalySite Not Available
IRCCS Materno Infantile Burlo Garofolo
Trieste 3165185, 34137
ItalySite Not Available
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Emma Children's Hospital Academic Medical Center
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Emma Children's Hospital Academic Medical Center
Amsterdam 2759794, 1105 AZ
NetherlandsSite Not Available
Radboudumc Amalia Children's Hospital
Nijmegen, 6500 HB
NetherlandsSite Not Available
Isala Kliniek
Zwolle, 8000 GK
NetherlandsSite Not Available
Isala Kliniek
Zwolle 2743477, 8000 GK
NetherlandsSite Not Available
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
Bydgoszcz, 85 094
PolandSite Not Available
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
Bydgoszcz, 85-094
PolandSite Not Available
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
Bydgoszcz 3102014, 85 094
PolandSite Not Available
Szpital im. M. Kopernika
Gdansk, 80 803
PolandSite Not Available
Szpital im. M. Kopernika
Gdansk 3099434, 80 803
PolandSite Not Available
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, 30 663
PolandSite Not Available
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow 3094802, 30 663
PolandSite Not Available
Uniwersytecki Szpital Dzieciecy w Krakowie
Kraków, 30-663
PolandSite Not Available
Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego
Olsztyn, 10 561
PolandSite Not Available
Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego
Olsztyn, 10-561
PolandSite Not Available
Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego
Olsztyn 763166, 10 561
PolandSite Not Available
Korczowski Bartosz Gabinet Lekarski
Rzeszow, 35-302
PolandSite Not Available
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, 35-302
PolandSite Not Available
Korczowski Bartosz Gabinet Lekarski
Rzeszów, 35-302
PolandSite Not Available
Korczowski Bartosz Gabinet Lekarski
Rzeszów 759734, 35-302
PolandSite Not Available
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warsaw, 00 635
PolandSite Not Available
Szpital Pomnik Centrum Zdrowia Dziecka
Warsaw, 04-730
PolandSite Not Available
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warsaw 756135, 00 635
PolandSite Not Available
Szpital Pomnik Centrum Zdrowia Dziecka
Warsaw 756135, 04-730
PolandSite Not Available
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warszawa, 00 635
PolandSite Not Available
Centrum Zdrowia Matki, Dziecka i Młodzieży
Warszawa, 00-635
PolandSite Not Available
Szpital Pomnik Centrum Zdrowia Dziecka
Warszawa, 04-730
PolandSite Not Available
Kyungpook National University Chilgok Hospital
Daegu, 41404
South KoreaSite Not Available
Kyungpook National University Chilgok Hospital
Daegu 1835329, 41404
South KoreaSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaSite Not Available
Samsung Medical Center
Seoul, 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul, 03080
South KoreaSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 03722
South KoreaSite Not Available
Asan Medical Center
Seoul 1835848, 05505
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available
Severance Hospital Yonsei University Health System
Seoul 1835848, 03722
South KoreaSite Not Available
Hosp. Univ. de Cruces
Barakaldo, 48902
SpainSite Not Available
Hosp. Univ. de Cruces
Barakaldo 3109453, 48902
SpainSite Not Available
Hosp. Sant Joan de Deu
Barcelona, 08950
SpainSite Not Available
Hosp. Sant Joan de Deu
Barcelona 3128760, 08950
SpainSite Not Available
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28036
SpainSite Not Available
Hosp. Gral. Univ. Gregorio Marañon
Madrid, 28036
SpainSite Not Available
Hosp. Infantil Univ. Nino Jesus
Madrid, 28009
SpainSite Not Available
Hosp. Infantil Univ. Niño Jesus
Madrid, 28009
SpainSite Not Available
Hosp. Univ. 12 De Octubre
Madrid, 28041
SpainSite Not Available
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hosp. Gral. Univ. Gregorio Maranon
Madrid 3117735, 28036
SpainSite Not Available
Hosp. Infantil Univ. Nino Jesus
Madrid 3117735, 28009
SpainSite Not Available
Hosp. Univ. 12 de Octubre
Madrid 3117735, 28041
SpainSite Not Available
Hosp Regional Univ de Malaga
Málaga, 29011
SpainSite Not Available
Hosp. Regional Univ. de Malaga
Málaga, 29011
SpainSite Not Available
Hosp Regional Univ de Malaga
Málaga 2514256, 29011
SpainSite Not Available
Hosp. Sant Joan de Deu
Sant Cugat Del Vallés, 08173
SpainSite Not Available
Hosp. Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Hosp. Virgen Del Rocio
Seville, 41013
SpainSite Not Available
Hosp. Virgen Del Rocio
Seville 2510911, 41013
SpainSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 112
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341, 100
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei 1668341, 112
TaiwanSite Not Available
Chang Gung Memorial Hospital- Linkou
Taoyuan, 33305
TaiwanSite Not Available
Chang Gung Memorial Hospital- Linkou
Taoyuan 6696918, 33305
TaiwanSite Not Available
Chang Gung Memorial Hospital- Linkou
Taoyuan City, 33305
TaiwanSite Not Available
University of California San Francisco
San Francisco, California 94158
United StatesSite Not Available
University of California San Francisco
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
Children's Hospital Colorado and University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Rocky Mountain Pediatric Gastroenterology
Lone Tree, Colorado 80124
United StatesSite Not Available
Children's Hospital Colorado and University of Colorado
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Rocky Mountain Pediatric Gastroenterology
Lone Tree 5429208, Colorado 5417618 80124
United StatesSite Not Available
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesSite Not Available
Connecticut Children's Medical Center
Hartford 4835797, Connecticut 4831725 06106
United StatesSite Not Available
Nemours DuPont Hospital for Children
Wilmington, Delaware 19803
United StatesSite Not Available
Nemours DuPont Hospital for Children
Wilmington 4145381, Delaware 4142224 19803
United StatesSite Not Available
Children's Center for Digestive Health Care
Atlanta, Georgia 30342
United StatesSite Not Available
Children's Center for Digestive Health Care
Atlanta 4180439, Georgia 4197000 30342
United StatesSite Not Available
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
GI For Kids
Knoxville, Tennessee 37922
United StatesSite Not Available
GI For Kids
Knoxville 4634946, Tennessee 4662168 37922
United StatesSite Not Available
Children's Medical Center of Dallas
Dallas, Texas 75207
United StatesSite Not Available
Cook Childrens Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
DHAT Research Institute
Garland, Texas 75044
United StatesSite Not Available
DHAT Research Institute
Plano, Texas 75093
United StatesSite Not Available
Children's Medical Center of Dallas
Dallas 4684888, Texas 4736286 75207
United StatesSite Not Available
Cook Childrens Medical Center
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
DHAT Research Institute
Garland 4693003, Texas 4736286 75044
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.