Back to resultsA Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PURSUIT 2)
Primary Purpose
Colitis, Ulcerative
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Golimumab
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative
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
Sites / Locations
- University of California San Francisco
- Children's Hospital Colorado and University of Colorado
- Rocky Mountain Pediatric Gastroenterology
- Connecticut Children's Medical Center
- Nemours DuPont Hospital for Children
- Children's Center for Digestive Health Care
- Mayo Clinic
- Columbia University Medical Center
- GI For Kids
- Children's Medical Center of Dallas
- Cook Childrens Medical Center
- DHAT Research Institute
- Universitair Kinderziekenhuis Koningin Fabiola
- Cliniques Universitaires Saint-Luc
- UZ Brussel
- MK Blumenau Pesquisa Clínica
- Hospital Pequeno Principe
- Irmandade Santa Casa de Misericordia de Porto Alegre
- BR Trials
- Hopital Pellegrin CHU Bordeaux
- Hôpital Necker
- Rambam Medical Center
- Shaare Zedek Medical Center
- Schneider Children's Medical Center
- Sheba Medical Center
- Assaf Harofeh Medical Center
- Sourasky Medical Center
- Azienda USL di Bologna - Ospedale Maggiore
- AOU Meyer
- AOU Policlinico G.Martino
- AOU Policlinico Umberto I
- IRCCS Ospedale Pediatrico Bambino Gesu
- Casa Sollievo della Sofferenza, IRCCS
- IRCCS Materno Infantile Burlo Garofolo
- Kyungpook National University Chilgok Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Samsung Medical Center
- Emma Children's Hospital Academic Medical Center
- Isala Kliniek
- Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
- Szpital im. M. Kopernika
- Uniwersytecki Szpital Dzieciecy w Krakowie
- Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego
- Korczowski Bartosz, Gabinet Lekarski
- Centrum Zdrowia Matki, Dziecka i Młodzieży
- Szpital Pomnik Centrum Zdrowia Dziecka
- Hosp. Univ. de Cruces
- Hosp. Sant Joan de Deu
- Hosp. Infantil Univ. Niño Jesus
- Hosp. Gral. Univ. Gregorio Maranon
- Hosp. Univ. 12 de Octubre
- Hosp. Regional Univ. de Malaga
- Hosp. Virgen Del Rocio
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital- Linkou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1: Golimumab
Group 2: Infliximab
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Clinical Remission at Week 6 as Assessed by the Mayo Score
Clinical remission is defined as a Mayo score less than or equal to (<=) 2 points, with no individual sub score greater than (>) 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Secondary Outcome Measures
Symptomatic Remission at Week 54
Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Clinical Remission at Week 54 as Assessed by the Mayo score
Clinical remission is defined as a Mayo score <=2 points, with no individual subscore >1 (based on Mayo endoscopy subscore assigned by the local endoscopist). The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score
Clinical remission is defined as a PUCAI score less than (<)10. The PUCAI is a noninvasive measure of UC disease activity. It comprises 6 scales and total score ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI total score is calculated as the sum of the 6 subscores. Higher scores indicate a more severe disease.
Clinical Remission at Week 6 as Assessed by the PUCAI Score
Clinical remission is defined as a PUCAI score <10. The PUCAI is a noninvasive measure of ulcerative colitis (UC) disease activity. It comprises 6 scales and total score ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI total score is calculated as the sum of the 6 subscores. Higher scores indicate a more severe disease.
Clinical Response at Week 6 as Assessed by the Mayo Score
Clinical response is defined as a decrease from baseline in the Mayo score of greater than or equal to (>=)30 percent (%) and >=3 points, with either a decrease from baseline in the rectal bleeding subscore of >=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Endoscopic Healing at Week 6
Endoscopic healing is defined as an endoscopy subscore of the Mayo score of 0 (normal or inactive disease) or 1 (mild disease).
Endoscopic Healing at Week 54
Endoscopic healing is defined as an endoscopy subscore of the Mayo score of 0 (normal or active disease) or 1 (mild disease).
Clinical Remission at Week 54 Assessed by the Mayo score for Participants who are in Clinical Remission at Week 6
Clinical remission is defined as a Mayo score <=2 points, with no individual subscore >1 (based on Mayo endoscopy subscore assigned by the local endoscopist). The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Number of Participants who were not Receiving Corticosteroids for At least 12 Weeks Prior to Week 54 and in Clinical Remission at Week 54
Number of participants who were not receiving corticosteroids for at least 12 Weeks prior to Week 54 and in clinical remission at Week 54 will be reported.
Full Information
NCT ID
NCT03596645
First Posted
July 13, 2018
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03596645
Brief Title
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Acronym
PURSUIT 2
Official Title
A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Golimumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Infliximab
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Golimumab
Intervention Description
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
Intervention Name(s)
Infliximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Remission at Week 6 as Assessed by the Mayo Score
Description
Clinical remission is defined as a Mayo score less than or equal to (<=) 2 points, with no individual sub score greater than (>) 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Time Frame
At Week 6
Secondary Outcome Measure Information:
Title
Symptomatic Remission at Week 54
Description
Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Time Frame
At Week 54
Title
Clinical Remission at Week 54 as Assessed by the Mayo score
Description
Clinical remission is defined as a Mayo score <=2 points, with no individual subscore >1 (based on Mayo endoscopy subscore assigned by the local endoscopist). The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Time Frame
At Week 54
Title
Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score
Description
Clinical remission is defined as a PUCAI score less than (<)10. The PUCAI is a noninvasive measure of UC disease activity. It comprises 6 scales and total score ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI total score is calculated as the sum of the 6 subscores. Higher scores indicate a more severe disease.
Time Frame
At Week 54
Title
Clinical Remission at Week 6 as Assessed by the PUCAI Score
Description
Clinical remission is defined as a PUCAI score <10. The PUCAI is a noninvasive measure of ulcerative colitis (UC) disease activity. It comprises 6 scales and total score ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI total score is calculated as the sum of the 6 subscores. Higher scores indicate a more severe disease.
Time Frame
At Week 6
Title
Clinical Response at Week 6 as Assessed by the Mayo Score
Description
Clinical response is defined as a decrease from baseline in the Mayo score of greater than or equal to (>=)30 percent (%) and >=3 points, with either a decrease from baseline in the rectal bleeding subscore of >=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Time Frame
At Week 6
Title
Endoscopic Healing at Week 6
Description
Endoscopic healing is defined as an endoscopy subscore of the Mayo score of 0 (normal or inactive disease) or 1 (mild disease).
Time Frame
At Week 6
Title
Endoscopic Healing at Week 54
Description
Endoscopic healing is defined as an endoscopy subscore of the Mayo score of 0 (normal or active disease) or 1 (mild disease).
Time Frame
At Week 54
Title
Clinical Remission at Week 54 Assessed by the Mayo score for Participants who are in Clinical Remission at Week 6
Description
Clinical remission is defined as a Mayo score <=2 points, with no individual subscore >1 (based on Mayo endoscopy subscore assigned by the local endoscopist). The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Time Frame
At Week 54
Title
Number of Participants who were not Receiving Corticosteroids for At least 12 Weeks Prior to Week 54 and in Clinical Remission at Week 54
Description
Number of participants who were not receiving corticosteroids for at least 12 Weeks prior to Week 54 and in clinical remission at Week 54 will be reported.
Time Frame
At Week 54
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital Colorado and University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Pediatric Gastroenterology
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Nemours DuPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's Center for Digestive Health Care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
GI For Kids
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75207
Country
United States
Facility Name
Cook Childrens Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
DHAT Research Institute
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Universitair Kinderziekenhuis Koningin Fabiola
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
MK Blumenau Pesquisa Clínica
City
Blumenau
ZIP/Postal Code
89010-506
Country
Brazil
Facility Name
Hospital Pequeno Principe
City
Curitiba
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
BR Trials
City
São Paulo
ZIP/Postal Code
05003-090
Country
Brazil
Facility Name
Hopital Pellegrin CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Rishon-Le-Zion
ZIP/Postal Code
70300
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
6997801
Country
Israel
Facility Name
Azienda USL di Bologna - Ospedale Maggiore
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
AOU Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
AOU Policlinico G.Martino
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
AOU Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesu
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Casa Sollievo della Sofferenza, IRCCS
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
IRCCS Materno Infantile Burlo Garofolo
City
Trieste
ZIP/Postal Code
34137
Country
Italy
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Emma Children's Hospital Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Isala Kliniek
City
Zwolle
ZIP/Postal Code
8000 GK
Country
Netherlands
Facility Name
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Szpital im. M. Kopernika
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Centrum Zdrowia Matki, Dziecka i Młodzieży
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Szpital Pomnik Centrum Zdrowia Dziecka
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Hosp. Univ. de Cruces
City
Barakaldo
ZIP/Postal Code
48902
Country
Spain
Facility Name
Hosp. Sant Joan de Deu
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hosp. Infantil Univ. Niño Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Regional Univ. de Malaga
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital- Linkou
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
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