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A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PURSUIT 2)

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ClinicalTrials.gov Identifier: NCT03596645
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Golimumab Drug: Infliximab Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : December 22, 2021
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Golimumab
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.
Drug: Golimumab
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.

Experimental: Group 2: 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.
Drug: 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 :
  1. Clinical Remission at Week 6 as Assessed by the Mayo Score [ Time Frame: 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 :
  1. Symptomatic Remission at Week 54 [ Time Frame: At Week 54 ]
    Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

  2. Clinical Remission at Week 54 as Assessed by the Mayo score [ Time Frame: 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.

  3. Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score [ Time Frame: 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.

  4. Clinical Remission at Week 6 as Assessed by the PUCAI Score [ Time Frame: 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.

  5. Clinical Response at Week 6 as Assessed by the Mayo Score [ Time Frame: 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.

  6. Endoscopic Healing at Week 6 [ Time Frame: 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).

  7. Endoscopic Healing at Week 54 [ Time Frame: 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).



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Acceptable evidence of immunity to measles, mumps, rubella, and varicella

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596645


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
United States, Colorado
Children's Hospital Colorado and University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Rocky Mountain Pediatric Gastroenterology Recruiting
Lone Tree, Colorado, United States, 80124
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
United States, Delaware
Nemours DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
United States, Georgia
Children's Center for Digestive Health Care Recruiting
Atlanta, Georgia, United States, 30342
United States, Massachusetts
Boston Children's Hospital Withdrawn
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina at Chapel Hill Withdrawn
Chapel Hill, North Carolina, United States, 27599
United States, South Carolina
Medical University of South Carolina Withdrawn
Charleston, South Carolina, United States, 29425
United States, Texas
Children's Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75207
Cook Childrens Medical Center Recruiting
Fort Worth, Texas, United States, 76104
DHAT Research Institute Recruiting
Garland, Texas, United States, 75044
Belgium
Universitair Kinderziekenhuis Koningin Fabiola Recruiting
Brussel, Belgium, 1020
Cliniques Universitaires Saint-Luc Recruiting
Brussel, Belgium, 1200
UZ Brussel Recruiting
Jette, Belgium, 1090
Brazil
MK Blumenau Pesquisa Clínica Recruiting
Blumenau, Brazil, 89010-506
Hospital Pequeno Principe Recruiting
Curitiba, Brazil, 80250-060
Hospital da Crianca Santo Antonio de Porto Alegre Recruiting
Porto Alegre, Brazil, 92020-430
France
Hôpital Pellegrin CHU Bordeaux Recruiting
Bordeaux, France, 33000
Hopital Femme Mère Enfant Withdrawn
Bron, France, 69677
Hôpital Necker Recruiting
Paris, France, 75015
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 3109601
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Assaf Harofeh Medical Center Recruiting
Rishon-Le-Zion, Israel, 70300
Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 6997801
Italy
Azienda USL di Bologna - Ospedale Maggiore Recruiting
Bologna, Italy, 40133
AOU Policlinico G.Martino Recruiting
Messina, Italy, 98124
AOU Policlinico Umberto I Recruiting
Roma, Italy, 00161
IRCCS Ospedale Pediatrico Bambino Gesu Recruiting
Roma, Italy, 00165
IRCCS Materno Infantile Burlo Garofolo Recruiting
Trieste, Italy, 34137
Korea, Republic of
Kyungpook National University Chilgok Hospital Recruiting
Daegu, Korea, Republic of, 41404
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Netherlands
Emma Children's Hospital Academic Medical Center Not yet recruiting
Amsterdam, Netherlands, 1105 AZ
Radboudumc Amalia Children's Hospital Withdrawn
Nijmegen, Netherlands, 6500 HB
Isala Kliniek Not yet recruiting
Zwolle, Netherlands, 8000 GK
Poland
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza Recruiting
Bydgoszcz, Poland, 85-094
Szpital im. M. Kopernika Recruiting
Gdansk, Poland, 80-803
Uniwersytecki Szpital Dzieciecy w Krakowie Recruiting
Kraków, Poland, 30-663
Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego Recruiting
Olsztyn, Poland, 10-561
Centrum Zdrowia Matki, Dziecka i Młodzieży Recruiting
Warszawa, Poland, 00-635
Szpital Pomnik Centrum Zdrowia Dziecka Recruiting
Warszawa, Poland, 04-730
Spain
Hosp. Univ. de Cruces Recruiting
Barakaldo, Spain, 48902
Hosp. Sant Joan de Deu Recruiting
Barcelona, Spain, 08950
Hosp. Infantil Univ. Niño Jesus Recruiting
Madrid, Spain, 28009
Hosp. Gral. Univ. Gregorio Maranon Recruiting
Madrid, Spain, 28036
Hosp. Univ. 12 de Octubre Recruiting
Madrid, Spain, 28041
Hosp. Regional Univ. de Malaga Recruiting
Málaga, Spain, 29011
Hosp. Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Chang Gung Memorial Hospital- Linkou Recruiting
Taoyuan City, Taiwan, 33305
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03596645     History of Changes
Other Study ID Numbers: CR108499
2017-004496-31 ( EudraCT Number )
CNTO148UCO3003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Infliximab
Antibodies, Monoclonal
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs