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Monoclonal Antibodies

Golimumab for Ulcerative Colitis

Phase 1
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 54 and week 110
Awards & highlights

Study Summary

This trial will test how safe and effective golimumab is in kids with UC aged 2-17.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 54 and week 110
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 54 and week 110 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum golimumab concentrations at Week 6
Secondary outcome measures
Number of participants who will achieve clinical remission at Week 54 and Week 110 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score
Number of participants who will achieve clinical remission at Week 6 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score
Number of participants who will achieve clinical remission at Week 6 measured by the Mayo score
+2 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: GolimumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Golimumab
2014
Completed Phase 4
~3480

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,273 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
3,959,870 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

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

Does Golimumab present any potential health hazards for individuals?

"Golimumab's safety is estimated to be a 1 due to the limited clinical data from Phase 1 trials, which suggests minimal efficacy and uncertain safety."

Answered by AI

Which demographic is able to partake in this research project?

"This clinical trial is seeking 35 young participants, aged 2 to 17, who have been diagnosed with ulcerative colitis. Admissible candidates must possess a Mayo score between 6 and 12 inclusive, display signs of endoscopic inflammation (subscore ≥2), previously received or be unable to take corticosteroids/6-mercaptopurine/azathioprine OR be dependent on steroids for UC management OR require 3+ steroid courses in the last year. In addition, applicants should not have any history of tuberculosis nor lack protective antibodies against varicella or measles prior to drug administration."

Answered by AI

What is the maximum number of participants accepted for this trial?

"At this juncture, individuals are not being solicited for participation in this clinical trial. This particular experiment was first posted on August 9th 2013 and has been updated most recently on December 1st 2022. Those seeking alternative studies may find 399 trials actively recruiting patients with colitis or ulcerative conditions, as well as 15 different studies searching for participants to test Golimumab treatments."

Answered by AI

Are new participants being recruited for this experiment?

"This clinical trial is no longer accepting participants. It was first posted in 2013 and last updated at the start of December 2022. As an alternative, 399 trials recruiting patients with colitis ulcerative are ongoing while 15 separate studies require volunteers for Golimumab testing."

Answered by AI

Are senior citizens being recruited as participants in this experiment?

"As stipulated in the trial conditions, participants must fall within a two to seventeen year age range."

Answered by AI

What is the scope of this investigation in terms of medical facilities involved?

"Presently, 12 medical sites are taking part in this trial. Those include Morristown, Seattle and Phoenix, as well as other cities across the USA. It is advised that participants select a site closest to them for easier access and reduced travel demands."

Answered by AI

Has Golimumab been evaluated in any prior research studies?

"15 clinical trials for golimumab are in progress, 6 of which have entered Phase 3. Hasselt, Limburg is home to many of these investigations; however, there are 263 other sites involved with the research."

Answered by AI

What pathologies does Golimumab typically help ameliorate?

"Golimumab is a medication approved to treat rheumatoid arthritis, psoriatic and moderate active forms of the disease."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
2013. "A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01900574.
~3 spots leftby Apr 2025
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