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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 1, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE October 29, 2018
Estimated Primary Completion Date December 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03596645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • 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 >=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.
  • Clinical Remission at Week 6 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (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.
  • 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).
  • Clinical Remission at Week 54 as Assessed by the PUCAI Score [ Time Frame: At Week 54 ]
    Clinical remission is defined as a PUCAI score <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.
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Golimumab
  • 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.
    Intervention: Drug: Infliximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2018)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2024
Estimated Primary Completion Date December 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Belgium,   Brazil,   France,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03596645
Other Study ID Numbers  ICMJE CR108499
2017-004496-31 ( EudraCT Number )
CNTO148UCO3003 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP