A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Interventions
- Registration Number
- NCT03596645
- Lead Sponsor
- Janssen Research & Development, LLC
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Golimumab Golimumab Participants will receive subcutaneous (SC) golimumab through Week 50. Doses will be based on body surface area. Following the Week 54 evaluations (end of main pivotal study) participants who are benefiting from golimumab at the discretion of the investigator may continue to receive SC golimumab in an extension period until end of study. Group 2: Infliximab 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.
- Primary Outcome Measures
Name Time Method Clinical Remission at Week 6 as Assessed by the Mayo Score At Week 6 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
Name Time Method Clinical Remission at Week 54 as Assessed by the Mayo score At Week 54 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 At Week 54 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 At Week 6 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.
Symptomatic Remission at Week 54 At Week 54 Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Endoscopic Healing at Week 6 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).
Clinical Response at Week 6 as Assessed by the Mayo Score At Week 6 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 54 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 At Week 54 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 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.
Trial Locations
- Locations (58)
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
🇵🇱Bydgoszcz, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego
🇵🇱Olsztyn, Poland
Centrum Zdrowia Matki Dziecka i Mlodziezy
🇵🇱Warszawa, Poland
University of California San Francisco
🇺🇸San Francisco, California, United States
Children's Hospital Colorado and University of Colorado
🇺🇸Aurora, Colorado, United States
Rocky Mountain Pediatric Gastroenterology
🇺🇸Lone Tree, Colorado, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Nemours DuPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's Center for Digestive Health Care
🇺🇸Atlanta, Georgia, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
GI For Kids
🇺🇸Knoxville, Tennessee, United States
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
Cook Childrens Medical Center
🇺🇸Fort Worth, Texas, United States
DHAT Research Institute
🇺🇸Garland, Texas, United States
Universitair Kinderziekenhuis Koningin Fabiola
🇧🇪Brussel, Belgium
Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Belgium
UZ Brussel
🇧🇪Jette, Belgium
MK Blumenau Pesquisa ClÃnica
🇧🇷Blumenau, Brazil
Hospital Pequeno Principe
🇧🇷Curitiba, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
BR Trials
🇧🇷Sao Paulo, Brazil
Hopital Pellegrin CHU Bordeaux
🇫🇷Bordeaux, France
Hôpital Necker
🇫🇷Paris, France
Rambam Medical Center
🇮🇱Haifa, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Schneider Children's Medical Center
🇮🇱Petah Tikva, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Assaf Harofeh Medical Center
🇮🇱Rishon-Le-Zion, Israel
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Azienda USL di Bologna - Ospedale Maggiore
🇮🇹Bologna, Italy
AOU Meyer
🇮🇹Firenze, Italy
AOU Policlinico G.Martino
🇮🇹Messina, Italy
AOU Policlinico Umberto I
🇮🇹Roma, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
🇮🇹Roma, Italy
Casa Sollievo Della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo, Italy
IRCCS Materno Infantile Burlo Garofolo
🇮🇹Trieste, Italy
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Emma Children's Hospital Academic Medical Center
🇳🇱Amsterdam, Netherlands
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Isala Kliniek
🇳🇱Zwolle, Netherlands
Szpital im. M. Kopernika
🇵🇱Gdansk, Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
🇵🇱Krakow, Poland
Korczowski Bartosz Gabinet Lekarski
🇵🇱Rzeszow, Poland
Szpital Pomnik Centrum Zdrowia Dziecka
🇵🇱Warszawa, Poland
Hosp. Univ. de Cruces
🇪🇸Barakaldo, Spain
Hosp. Sant Joan de Deu
🇪🇸Barcelona, Spain
Hosp. Infantil Univ. Nino Jesus
🇪🇸Madrid, Spain
Hosp. Gral. Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Hosp Regional Univ de Malaga
🇪🇸Málaga, Spain
Hosp. Virgen Del Rocio
🇪🇸Sevilla, Spain
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital- Linkou
🇨🇳Taoyuan City, Taiwan