Clinical trial NCT03596645: A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Colitis, Ulcerative
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical Remission at Week 6 as Assessed by the Mayo Score
timeFrame: At Week 6
Secondary outcomes:
measure: Symptomatic Remission at Week 54
timeFrame: At Week 54
measure: Clinical Remission at Week 54 as Assessed by the Mayo score
timeFrame: At Week 54
measure: Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score
timeFrame: At Week 54
measure: Clinical Remission at Week 6 as Assessed by the PUCAI Score
timeFrame: At Week 6
measure: Clinical Response at Week 6 as Assessed by the Mayo Score
timeFrame: At Week 6
measure: Endoscopic Healing at Week 6
timeFrame: At Week 6
measure: Endoscopic Healing at Week 54
timeFrame: At Week 54
measure: Clinical Remission at Week 54 Assessed by the Mayo score for Participants who are in Clinical Remission at Week 6
timeFrame: At Week 54
measure: Number of Participants who were not Receiving Corticosteroids for At least 12 Weeks Prior to Week 54 and in Clinical Remission at Week 54
timeFrame: At Week 54
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado and University of Colorado
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Pediatric Gastroenterology
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Wilmington
country: United States
facility: Nemours DuPont Hospital for Children
state: Delaware
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Knoxville
country: United States
facility: GI For Kids
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Childrens Medical Center
state: Texas
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Brussel
country: Belgium
facility: Universitair Kinderziekenhuis Koningin Fabiola
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Jette
country: Belgium
facility: UZ Brussel
city: Blumenau
country: Brazil
facility: MK Blumenau Pesquisa Clínica
city: Curitiba
country: Brazil
facility: Hospital Pequeno Principe
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Sao Paulo
country: Brazil
facility: BR Trials
city: Bordeaux
country: France
facility: Hopital Pellegrin CHU Bordeaux
city: Paris
country: France
facility: Hôpital Necker
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rishon-Le-Zion
country: Israel
facility: Assaf Harofeh Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Bologna
country: Italy
facility: Azienda USL di Bologna - Ospedale Maggiore
city: Firenze
country: Italy
facility: AOU Meyer
city: Messina
country: Italy
facility: AOU Policlinico G.Martino
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo Della Sofferenza IRCCS
city: Trieste
country: Italy
facility: IRCCS Materno Infantile Burlo Garofolo
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: Emma Children's Hospital Academic Medical Center
city: Zwolle
country: Netherlands
facility: Isala Kliniek
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
city: Gdansk
country: Poland
facility: Szpital im. M. Kopernika
city: Krakow
country: Poland
facility: Uniwersytecki Szpital Dzieciecy w Krakowie
city: Olsztyn
country: Poland
facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego
city: Rzeszow
country: Poland
facility: Korczowski Bartosz Gabinet Lekarski
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki Dziecka i Mlodziezy
city: Warszawa
country: Poland
facility: Szpital Pomnik Centrum Zdrowia Dziecka
city: Barakaldo
country: Spain
facility: Hosp. Univ. de Cruces
city: Barcelona
country: Spain
facility: Hosp. Sant Joan de Deu
city: Madrid
country: Spain
facility: Hosp. Infantil Univ. Nino Jesus
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Málaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital- Linkou
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: