Immunosuppressant
Methylprednisolone plus Upadacitinib then increased Upadacitinib for Ulcerative Colitis
University of Michigan, Ann Arbor, MI
Upadacitinib Extended Release Oral Tablet +4 morePhase 4Waitlist AvailableLed by Jeffrey Berinstein, MD, MScResearch Sponsored by Berinstein, JeffreyEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)
Current hospital admission for ulcerative colitis treatment (expecting Intravenous (IV) corticosteroid initiation)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upapproximately 100 days (intervention plus 90 days of follow-up)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Study Summary
This trial aims to develop personalized treatments for people admitted to hospital with ASUC to help them avoid colectomy & ensure their safety. #ASUC #colectomy
Eligible Conditions
- Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 100 days (intervention plus 90 days of follow-up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 100 days (intervention plus 90 days of follow-up)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of enrolled patients that successfully underwent the second randomization (or transition to the second-stage among participants not re-randomized)
Proportion of inpatient physicians reporting trial design acceptable
Proportion of participants with completed C-Reactive Protein (CRP) and daily bowel movements recorded prior to sequentially randomized allocation
+3 moreSecondary outcome measures
Incidence and severity of adverse events
Proportion of patients in steroid-free remission at 90 days
Proportion of patients undergoing colectomy within follow-up
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
9Treatment groups
Experimental Treatment
Group I: Oral Upadacitinib then Methylprednisolone plus cyclosporine infusionExperimental Treatment3 Interventions
Upadacitinib 30 mg BID for stage 1. If a patient is a non-responder to Upadacitinib 30 mg, then the study team will stop Upadacitinib and initiate Methylprednisolone IV 30mg twice a day plus Cyclosporine (2 milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) for stage 2.
Group II: Oral Upadacitinib then MethylprednisoloneExperimental Treatment3 Interventions
Oral Upadacitinib 30mg BID for stage 1 then for patients that are non-responders, add rescue Methylprednisolone IV 30mg twice a day in addition to continuing Upadacitinib for stage 2.
Group III: Oral UpadacitinibExperimental Treatment1 Intervention
Upadacitinib 30 mg BID
Group IV: Methylprednisolone then UpadacitinibExperimental Treatment2 Interventions
Methylprednisolone IV 30mg twice a day Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2
Group V: Methylprednisolone then CyclosporineExperimental Treatment3 Interventions
Methylprednisolone IV 30 mg BID Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Cyclosporine (2milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) in addition to continuing Methylprednisolone for stage 2.
Group VI: Methylprednisolone plus Upadacitinib then increased UpadacitinibExperimental Treatment3 Interventions
Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and if determined to be a non-responder to Methylprednisolone and 45 mg Oral Upadacitinib, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2.
Group VII: Methylprednisolone plus Upadacitinib then cyclosporineExperimental Treatment3 Interventions
Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and then Cyclosporine 2 mg/kg per day aiming for levels 200-400ng/mL for stage 2.
Group VIII: Methylprednisolone plus UpadacitinibExperimental Treatment2 Interventions
Methylprednisolone IV 30mg BID plus Upadacitinib 45mg every day.
Group IX: MethylprednisoloneExperimental Treatment2 Interventions
Methylprednisolone Intravenous (IV) 30 milligram (mg) twice a day (BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclosporine Oral Product
2016
Completed Phase 4
~60
Intravenous Methylprednisolone
2011
N/A
~40
Find a site
Who is running the clinical trial?
Berinstein, JeffreyLead Sponsor
Jeffrey Berinstein, MD, MScPrincipal Investigator
University of MichiganMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 50 or older being enrolled in this research?
"This clinical trial is open to patients aged 18-75. For those underage and elderly individuals, there are 71 studies available for minors and 353 trials accessible to seniors."
Answered by AI
Is it possible to join the clinical experiment that is currently taking place?
"Admittance to this trial necessitates the presence of ulcerative colitis and a participant's age must lie between 18-75. Currently, 162 applicants are being accepted into this clinical experiment."
Answered by AI
Has Methylprednisolone been given the stamp of approval by the U.S. Food and Drug Administration?
"After careful evaluation, Methylprednisolone was given a score of 3 due to Phase 4 trial data that showed the drug's approval."
Answered by AI
Are there any openings in this research investigation for new participants?
"The information found on clinicaltrials.gov states that this experiment, which was initially published on May 1st 2023 and later edited on the 6th of the same month, is not currently recruiting patients. However, there are 409 other trials actively seeking participants at present."
Answered by AI
What effects and outcomes is this clinical investigation attempting to attain?
"This clinical trial is estimated to take approximately 100 days, and its primary goal is measuring the percentage of participants that complete both intervention and follow-up. Secondary objectives include quantifying colectomy events within the post-intervention period, assessing incidence/severity of adverse events such as shingles, acne, cardiovascular issues etc., and determining if patients are in steroid free remission at 90 day mark."
Answered by AI
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