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Immunosuppressant
Personalized Medication for Severe Ulcerative Colitis
Phase 4
Recruiting
Led By Jeffrey Berinstein, MD, MSc
Research Sponsored by Berinstein, Jeffrey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 100 days (intervention plus 90 days of follow-up)
Awards & highlights
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
Who is the study for?
This trial is for hospitalized patients with acute severe ulcerative colitis, who've had at least one dose of certain biologic treatments. They must be able to take oral meds, follow the study plan including daily symptom tracking, and women must use effective contraception during the study.Check my eligibility
What is being tested?
The trial aims to personalize treatment for ulcerative colitis using Upadacitinib tablets or Cyclosporine orally/injection along with standard steroids. It's testing if these strategies can prevent colectomy (surgical removal of the colon) safely before a larger trial.See study design
What are the potential side effects?
Possible side effects include increased infection risk due to immune system suppression, liver issues from Upadacitinib, kidney problems from Cyclosporine, and typical steroid-related effects like mood swings, blood sugar changes, and bone weakening.
Timeline
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 moreTrial 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 Location
Who is running the clinical trial?
Berinstein, JeffreyLead Sponsor
Jeffrey Berinstein, MD, MScPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or will have a major organ or bone marrow transplant within a year.I do not have an ongoing infection, including TB.I am not allergic to methylprednisolone, cyclosporine, tofacitinib, or upadacitinib.I do not have severe health issues related to kidneys, blood, digestion, hormones, lungs, heart, brain, or mental health.My liver function is not normal, with a score of 5 or higher.I have a type of colitis or symptoms that may suggest Crohn's disease.I have been on IV corticosteroids for at least 3 days before joining.I have been diagnosed with toxic megacolon during my current hospital stay.I have no cancer history, except for treated skin cancer.I do not have serious heart or blood clot issues.I have a confirmed CMV infection in my colon with significant signs under a microscope.I have a history of blood disorders or symptoms suggesting one.My blood pressure is not controlled even with medication.I have taken Upadacitinib before or other JAK inhibitors.I have been diagnosed with ulcerative colitis confirmed by tests and symptoms.I have had serious GI issues, like a perforation, not caused by injury or appendicitis.I have no conditions that affect how my body absorbs pills.I am currently in the hospital for ulcerative colitis and will start IV corticosteroids.I have taken a dose of a biologic drug for my condition.I am not on medications that highly increase my risk of blood clots.I haven't had live vaccines recently and won't during the study.I have had shingles more than once or a severe herpes infection.I can take pills and will follow the study's treatment plan.I am a woman under 55, not pregnant, and will use effective birth control for 3 months.I have had surgery to remove all or part of my colon, or I am planning to have bowel surgery.I am allergic to certain medications similar to the treatment.I have severe ulcerative colitis with frequent bloody bowel movements and at least one other symptom like fever or fast heartbeat.I am willing and able to follow the study's schedule and procedures.I am not taking, nor plan to take, strong CYP3A4 drugs during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Upadacitinib then Methylprednisolone plus cyclosporine infusion
- Group 2: Methylprednisolone plus Upadacitinib then cyclosporine
- Group 3: Methylprednisolone plus Upadacitinib then increased Upadacitinib
- Group 4: Methylprednisolone
- Group 5: Methylprednisolone plus Upadacitinib
- Group 6: Oral Upadacitinib
- Group 7: Methylprednisolone then Cyclosporine
- Group 8: Methylprednisolone then Upadacitinib
- Group 9: Oral Upadacitinib then Methylprednisolone
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
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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