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Guselkumab for Pediatric Crohn's Disease (MACARONI-23 Trial)
MACARONI-23 Trial Summary
This trial studies how well guselkumab works to treat Crohn's Disease in children after 12 weeks of therapy.
MACARONI-23 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MACARONI-23 Trial Design
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Who is running the clinical trial?
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- I do not have an abscess.I have Crohn's disease and treatments like immunomodulators, steroids, or biologics/JAK inhibitors haven't worked well for me.I haven't had bowel surgery in the last 6 months or any abdominal surgery in the last 3 months.I have been diagnosed with Crohn's Disease or fistulizing Crohn's Disease.My Crohn's disease is moderate to severe.I have Crohn's disease with complications that may need surgery.My endoscopy shows active Crohn's Disease with a specific severity score.
- Group 1: Open-label maintenance phase: Guselkumab SC
- Group 2: Open-label induction phase: Guselkumab Intravenously (IV)
- Group 3: Double-blind maintenance phase: Guselkumab SC or Guselkumab SC and Placebo SC
- Group 4: Open-label induction phase: Guselkumab Subcutaneously (SC)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Is this trial accepting participants who are thirty and over?
"As per the study's parameters, children aged two to seventeen are eligible for enrollment."
Could you please explain the potential adverse effects of Guselkumab IV in an open-label induction phase?
"There is clinical evidence to suggest guselkumab IV's efficacy and safety, resulting in an overall assessment of 3 on a scale from 1-3."
In how many distinct locations is this experiment administered?
"Multiple sites are currently registering patients, such as Arkansas Children's Hospital Research Institute in Little Rock, Cedars-Sinai Medical Center in Los Angeles and University of California San Francisco. In addition to these locations, 80 more medical centres across the US are participating."
What are the requirements for joining this clinical trial?
"To meet the stipulations of this clinical trial, prospective patients must be between two and seventeen years old with a diagnosis of Crohn's disease. Currently, approximately 120 participants are being sought after."
Are there any current opportunities for individuals to join this trial?
"According to the information hosted on clinicialtrials.gov, this medical trial is not presently taking in participants. It was initially posted on September 19th 2023 and amended most recently on June 20th 2023. However, 262 other clinical studies are actively recruiting now."
What beneficial results has this experiment been designed to yield?
"According to Janssen Research & Development, LLC, the primary outcome that will be monitored over a 52-week period is the percentage of patients who experience endoscopic response at Week 52. Secondary outcomes being measured include clinical response (defined as decrease from baseline/LOR in PCDAI score >=12.5 points with total PCDAI <=30) and remission (PCDAI score <=10), both assessed at Week 12; and additionally, endoscopic response (>=50% reduction from SES-CD score at baseline)."
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