Upadacitinib + Corticosteroids for Ulcerative Colitis Flare-Up
(ACUTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the best way to use medications for treating severe flare-ups of ulcerative colitis, a chronic inflammation of the colon. Researchers compare the effectiveness of the drug upadacitinib, an oral medication, combined with corticosteroids to corticosteroids alone. Participants are either hospitalized or treated as outpatients, with some receiving both drugs and others receiving a placebo instead of upadacitinib. This trial may suit individuals who have experienced at least six bloody bowel movements daily for the past week and have recently used oral corticosteroids. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot be on strong CYP3A4 inducers or inhibitors, which are certain types of medications, during the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.
What is the safety track record for these treatments?
Research has shown that upadacitinib, also known as RINVOQ, has been thoroughly studied for treating moderate to severe ulcerative colitis. The FDA has already approved it for this condition, indicating general safety. However, like many medications, it can cause side effects. Studies indicate that patients might experience infections, and some may develop acne. Specifically, in one study with 105 patients, about 32% reported side effects, with 23% experiencing acne.
Corticosteroids are also commonly used to treat inflammation and are usually well-tolerated. They can cause side effects like increased appetite, mood changes, or trouble sleeping, but these are typically manageable.
Overall, while both treatments can have side effects, they are considered safe for treating ulcerative colitis. Always consult a doctor about the potential risks and benefits specific to your health.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about upadacitinib in combination with corticosteroids for ulcerative colitis because it offers a novel approach by targeting the Janus kinase (JAK) pathway, which plays a key role in the immune response and inflammation. Unlike traditional treatments that primarily focus on broad immune suppression, upadacitinib provides more targeted action, potentially leading to faster symptom relief and improved outcomes. Additionally, the flexibility in dosing based on clinical symptoms and biomarkers allows for personalized treatment, which could enhance its effectiveness and safety compared to standard therapies.
What evidence suggests that this trial's treatments could be effective for acute severe ulcerative colitis?
Research has shown that upadacitinib effectively treats ulcerative colitis. Studies found that many patients experienced fewer symptoms after 8 and 16 weeks. Over the long term, upadacitinib remained effective and safe, helping patients manage their condition for up to three years. This trial will evaluate upadacitinib in combination with corticosteroids for ulcerative colitis flare-ups. Participants in one arm will receive upadacitinib plus steroids, while another arm will receive steroids plus a placebo for upadacitinib. This medication also quickly reduces the activity and severity of the disease, providing fast symptom relief. Based on this evidence, upadacitinib is considered a promising treatment option for ulcerative colitis.678910
Who Is on the Research Team?
Jeffrey Berinstein, MD, MSc
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for both inpatients and outpatients with acute severe ulcerative colitis (ASUC) experiencing a flare-up. Participants must meet specific health criteria to join, but the exact inclusion and exclusion details are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Eligibility Assessment
Participants are screened for eligibility to participate in the trial
Acute Induction
Participants receive upadacitinib and corticosteroids or corticosteroids alone as induction therapy
Post-Acute Induction
Participants continue treatment with upadacitinib and taper prednisone for 8 weeks
Maintenance
Upadacitinib therapy may continue with dosage titration based on clinical symptoms and inflammatory biomarkers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intravenous Methylprednisolone
- Oral prednisolone Taper
- Oral Upadacitinib
Trial Overview
The study compares the effectiveness of combining Upadacitinib with corticosteroids versus using corticosteroids alone as initial treatment for ASUC. It aims to determine which method works better early on.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
This will include patients who meet acute severe ulcerative colitis criteria who are seen in clinic, that contact the clinic, or are sent to the ambulatory, diagnostic and treatment unit (ADTU) without requiring an admission to the hospital. Participants will receive upadacitinib 45mg and hospital dose steroids (IV Methylprednisolone 60mg in an infusion center or ADTU or PO Prednisone 75mg) up to Day 5. If the participant's condition does not improve or if it worsens after 3 days from starting assigned treatment, the participant will be unblinded and put on "rescue therapy". Unrescued participants will be unblinded on Day 5 when the Acute Induction Phase is complete. Upon completion of the Acute Induction Phase, participants will receive upadacitinib 45 mg for 8 weeks concomitant with a 2-week prednisone course. Upadacitinib therapy may continue through week 48, with dosage (45 mg, 30 mg, or 15 mg) titrated based on clinical symptoms and inflammatory biomarkers.
This will include patients seen in the Emergency Department or who are hospitalized. Participants will receive upadacitinib 45mg and hospital dose steroids (IV Methylprednisolone 60mg) until they are discharged. If the participant's condition does not improve or if it worsens after 3 days from starting assigned treatment, the participant will be unblinded and put on "rescue therapy". Unrescued participants will be unblinded as soon as participants are discharged (completion of the Acute Induction Phase). Upon completion of the Acute Induction Phase, participants will receive upadacitinib 45 mg for 8 weeks concomitant with a 2-week prednisone course. Upadacitinib therapy may continue through week 48, with dosage (45 mg, 30 mg, or 15 mg) titrated based on clinical symptoms and inflammatory biomarkers.
This will include patients seen in the Emergency Department or who are hospitalized. Participants will receive upadacitinib placebo and hospital dose steroids (IV Methylprednisolone 60mg) until they are discharged. If the participant's condition does not improve or if it worsens after 3 days from starting assigned treatment, the participant will be unblinded and put on "rescue therapy". Unrescued participants will be unblinded as soon as participants are discharged (completion of the Acute Induction Phase) to guide maintenance therapy selection (outside of the trial protocol). Upon completion of the Acute Induction Phase, participants will taper prednisone by 5mg per week starting at 40mg with maintenance therapy initiation per usual care.
This will include patients who meet acute severe ulcerative colitis criteria who are seen in clinic, that contact the clinic, or are sent to the ambulatory, diagnostic and treatment unit (ADTU) without requiring an admission to the hospital. Participants will receive upadacitinib placebo and hospital dose steroids (IV Methylprednisolone 60mg in an infusion center or ADTU or PO Prednisone 75mg) up to Day 5. If the participant's condition does not improve or if it worsens after 3 days from starting assigned treatment, the participant will be unblinded and put on "rescue therapy". Unrescued participants will be unblinded on Day 5 to guide selection of maintenance therapy. Upon completion of the Acute Induction Phase, participants will receive taper prednisone by 5mg per week starting at 40mg with maintenance therapy initiation per usual care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Berinstein, Jeffrey
Lead Sponsor
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Citations
RINVOQ® (upadacitinib) Efficacy for Ulcerative Colitis
UC EFFICACY RESULTS · Durable Remission · Powerful Healing · Rapid Relief · Durable Remission. at Week 8 and 52 · Powerful Healing. at Weeks 8 and 52 · Rapid Relief.
Upadacitinib induction is effective and safe in ulcerative ...
Upadacitinib resulted in high rates of clinical remission at 8 and 16 weeks in this large real-world cohort of ulcerative colitis patients.
P0642 Assessment of the real-world effectiveness of ...
In a real-world global setting, UPA demonstrated significant efficacy in reducing disease activity, severity and UC-related symptoms over time.
Long-term efficacy and safety of upadacitinib in patients ...
Our findings show a favourable risk–benefit profile of upadacitinib in patients with moderately to severely active ulcerative colitis through 3 years of ...
RINVOQ® (upadacitinib) Results for Ulcerative Colitis (UC)
In clinical studies, RINVOQ helped people with UC experience remission at 8 weeks and 1 year. RINVOQ also helped deliver: Rapid symptom ...
RINVOQ® (upadacitinib) Safety Data
Long-term safety data through November 24, 2020 (64%-66% of patients had >1 year of exposure to RINVOQ; total exposure=2788 PY).
RINVOQ® (upadacitinib) - accessdata.fda.gov
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance ...
RINVOQ® (upadacitinib) for Ulcerative Colitis (UC)
Learn about a prescription treatment for adults with moderate to severe ulcerative colitis (UC). See Full Prescribing & Safety Info, and Boxed Warning.
well-studied safety profile
Patients treated with RINVOQ are at increased risk for developing infections that may lead to hospitalization or death.
(CGH-D-22-02573) Upadacitinib is Effective and Safe in ...
Table 4: Safety data of upadacitinib in ulcerative colitis and Crohn's disease patients. N = 105. Adverse effects – n (%), 34 (32.4). Acne – n (%), 24 (22.9).
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