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Monoclonal Antibodies
Golimumab for Ulcerative Colitis (PURSUIT 2 Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
No history of latent or active tuberculosis prior to screening
Must not have
Have UC limited to the rectum only or to <20 percent (%) of the colon
Presence or history of a fistula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 54
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will evaluate whether golimumab is effective in inducing remission in children with moderate to severe ulcerative colitis, as well as assessing its safety profile.
Who is the study for?
This trial is for children with moderate to severe ulcerative colitis who are up-to-date on immunizations. They must have tried or be unable to use certain UC treatments, like corticosteroids or immunosuppressants, and can't have a history of tuberculosis. Kids dependent on steroids or those needing multiple steroid courses may join; however, those with limited UC, fistulas, stomas, contraindications to the study drugs, serious health issues including malignancies or organ insufficiency cannot participate.
What is being tested?
The trial tests if golimumab can help achieve clinical remission in kids with ulcerative colitis as measured by the Mayo score. It compares golimumab's effectiveness and safety against another medication called infliximab that targets inflammation.
What are the potential side effects?
Golimumab and infliximab might cause immune system suppression leading to infections. There could also be reactions at the infusion site (where the drug enters the body), potential activation of latent tuberculosis if present before treatment starts, and possibly other allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ulcerative colitis is moderate to severe, confirmed by a Mayo score of 6-12.
Select...
I have never had tuberculosis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My ulcerative colitis affects only my rectum or less than 20% of my colon.
Select...
I have or had a fistula.
Select...
I have a history of major organ or system conditions.
Select...
I have had cancer, macrophage activation syndrome, or hemophagocytic lymphohistiocytosis before.
Select...
I have a stoma.
Select...
I cannot take golimumab, infliximab, or anti-TNF drugs due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 54
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 54
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Remission at Week 6 as Assessed by the Mayo Score
Secondary study objectives
Clinical Remission at Week 54 Assessed by the Mayo score for Participants who are in Clinical Remission at Week 6
Clinical Remission at Week 54 as Assessed by the Mayo score
Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score
+6 moreSide effects data
From 2016 Phase 4 trial • 205 Patients • NCT0209228514%
COLITIS ULCERATIVE
10%
NASOPHARYNGITIS
7%
OROPHARYNGEAL PAIN
7%
HEADACHE
7%
COLITIS
7%
NAUSEA
1%
PULMONARY EMBOLISM
1%
ACCIDENTAL OVERDOSE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Golimumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2: InfliximabExperimental Treatment1 Intervention
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.
Group II: Group 1: GolimumabExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Golimumab
2014
Completed Phase 4
~3610
Infliximab
2017
Completed Phase 4
~3350
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,004 Previous Clinical Trials
6,402,723 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
770 Previous Clinical Trials
3,978,463 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ulcerative colitis affects only my rectum or less than 20% of my colon.I have or had a fistula.I have a history of major organ or system conditions.I have been on a stable tube-feeding plan for at least 2 weeks and do not receive nutrition through my veins.I have had cancer, macrophage activation syndrome, or hemophagocytic lymphohistiocytosis before.I have tried or cannot take certain medications for my condition, or I've needed multiple steroid treatments.My ulcerative colitis is moderate to severe, confirmed by a Mayo score of 6-12.I have a stoma.I have never had tuberculosis.I cannot take golimumab, infliximab, or anti-TNF drugs due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Infliximab
- Group 2: Group 1: Golimumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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