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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 54
Awards & highlights

PURSUIT 2 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.Check my eligibility
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.See study design
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.

PURSUIT 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ulcerative colitis is moderate to severe, confirmed by a Mayo score of 6-12.
Select...
I have never had tuberculosis.

PURSUIT 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 54 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Remission at Week 6 as Assessed by the Mayo Score
Secondary outcome measures
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 more

Side effects data

From 2016 Phase 4 trial • 205 Patients • NCT02092285
14%
COLITIS ULCERATIVE
10%
NASOPHARYNGITIS
7%
HEADACHE
7%
OROPHARYNGEAL PAIN
7%
COLITIS
7%
NAUSEA
1%
PULMONARY EMBOLISM
1%
ACCIDENTAL OVERDOSE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Golimumab

PURSUIT 2 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
~3480
Infliximab
2017
Completed Phase 4
~3280

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,224 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
745 Previous Clinical Trials
3,959,821 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis

Media Library

Golimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03596645 — Phase 3
Ulcerative Colitis Research Study Groups: Group 2: Infliximab, Group 1: Golimumab
Ulcerative Colitis Clinical Trial 2023: Golimumab Highlights & Side Effects. Trial Name: NCT03596645 — Phase 3
Golimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03596645 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being sought for this experiment?

"Yes, this information is available on clinicaltrials.gov. The study in question was posted on October 29th, 2018 and was last updated four years later on October 12th, 2022."

Answered by AI

Has the Federal Drug Administration given Golimumab its seal of approval?

"There is prior clinical data supporting Golimumab's safety, so it received a score of 3."

Answered by AI

What are the medical prerequisites for joining this clinical research?

"Up to 100 people with ulcerative colitis aged 2-17 may be admitted into this trial. The most important patient criteria are as follows: Must have unsuccessfully tried, contraindicated for, or currently receiving treatment from oral/IV steroids, 6-mercaptopurine, methotrexate, or azathioprine; must have a history of corticosteroid dependency or required >3 courses of steroids in the past year; up to date on all immunizations according to local guidelines; moderately to severely active UC (based on Mayo score); no history of tuberculosis."

Answered by AI

What are the primary indications for golimumab?

"Golimumab can be used to ameliorate the symptoms of psoriasis, active polyarticular juvenile idiopathic arthritis (pjia), and psoriatic arthritis."

Answered by AI

Could patients below the age of 80 qualify for this clinical trial?

"According to the qualifications listed, individuals aged 2 to 17 are eligible for this particular clinical trial. In general, there are 80 different trials for minors and 403 for senior citizens."

Answered by AI

Could you provide more information on other scientific research projects that have used Golimumab?

"Golimumab was first researched in 2007 at the University of Nebraska Medical Centre. To date, there have been 226 completed studies on golimumab with 58 more currently active trials. The majority of these ongoing studies are based out of Atlanta, Georgia."

Answered by AI

How many guinea pigs are part of this test group?

"This study requires 100 eligible individuals to partake. If you are interested and meet the inclusion criteria, you may be able to take part in this trial at various locations such as Children's Center for Digestive Health Care in Atlanta, Georgia or University of California San Francisco in San Francisco, California."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Cook Childrens Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Cook Childrens Medical Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
2018. "A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03596645.
~1 spots leftby Jun 2024
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