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Guselkumab for Crohn's Disease (PROGRESS Trial)
PROGRESS Trial Summary
This trial tests if a drug can reduce the chance of Crohn's returning after surgery.
- Crohn's Disease
PROGRESS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PROGRESS Trial Design
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Who is running the clinical trial?
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- You have a CDAI score of less than 200.A woman of childbearing age must provide a negative serum beta-hCG test result during screening and a negative urine pregnancy test prior to randomization.You have had an ileocolonic surgical resection for Crohn's Disease, with no active CD anywhere in the gastrointestinal tract, at least 10 days after surgery (or 8 days after resumption of bowel activity) and not done to remove known dysplasiaFemale participants must abstain from donating eggs or freezing them for assisted reproduction purposes during the study and 12 weeks after their last intervention.You have a history of serious health issues affecting your kidneys, urinary system, blood, hormones, heart, blood vessels, lungs, joints, brain, mental health, or metabolism.You possess evidence of a Crohn's disease diagnosis obtained through endoscopic, histologic, radiologic, or resectional tissue studies.You have symptoms of Crohn's disease that may require surgery or make it difficult to evaluate your response to guselkumab treatment.You have had an active perianal disease or a draining fistula within the last 3 months, unless the fistula was removed during surgery. Skin tags are not considered a perianal disease.You have an abscess or are suspected to have one. If you had an abscess that was treated at least 3 weeks ago (for skin or anal abscess) or 8 weeks ago (for abdominal abscess) and you won't need any further surgery, you can still participate.
- Group 1: Group 1: Guselkumab
- Group 2: Group 2: Placebo
- 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
What safety measures have been taken for those taking Group 1: Guselkumab?
"Our experts at Power rate guselkumab's safety a 3, since it is currently in its third phase of research. This implies that there are supportive data for both efficacy and numerous rounds of tests attesting to the drug's security."
Are there any ongoing recruitment opportunities for this clinical investigation?
"According to the clinicaltrials.gov database, this study is actively searching for participants. The listing first went up on February 21st 2023 and has been updated as of March 13th 2023."
How many places are conducting this research endeavor?
"This medical research is enlisting participants from the University of California, San Francisco in San Francisco, Colorado; University of Colorado Denver Anschultz Medical Campus in Aurora, Connecticut and Medical Research Center of Connecticut in Hamden, Florida. In addition to those locations there are an additional 129 sites involved."
How many individuals are being invited to join this medical experiment?
"To conduct the trial, Janssen Research & Development, LLC must recruit 370 patients that meet the set inclusion criteria. This will be done at multiple locations throughout California, Colorado and Connecticut such as University of California in San Francisco and University of Colorado Denver Anschultz Medical Campus in Aurora."
Who else is applying?
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