Upadacitinib for Ulcerative Colitis
(RESCUE UC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment method for severe ulcerative colitis (UC) that hasn't improved with standard steroid treatment. It compares the use of a new drug, upadacitinib (a Janus kinase inhibitor), followed by infliximab if needed, to the usual treatment with infliximab alone. Individuals hospitalized with a severe UC flare-up who haven't responded to at least three days of steroid treatment might be suitable candidates. The goal is to determine if this new approach is as effective as the usual treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take strong CYP3A4 inhibitors or inducers while participating. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that upadacitinib is generally safe for people with ulcerative colitis (UC). Long-term use of this medication has not revealed any new safety concerns. In studies, patients taking upadacitinib did not experience more safety issues than those taking infliximab, a common UC treatment.
Upadacitinib has also proven effective for some patients when other treatments failed, suggesting it could be a viable option for those not responding to standard therapies. While all medications can have side effects, no major unexpected problems have been reported with upadacitinib in UC patients so far.12345Why do researchers think this study treatment might be promising for ulcerative colitis?
Researchers are excited about Upadacitinib for ulcerative colitis because it offers a different approach compared to standard treatments like Infliximab. While many current options target TNF-alpha proteins to reduce inflammation, Upadacitinib is a JAK inhibitor, which means it works by blocking specific enzymes involved in the inflammatory process. This new mechanism of action could potentially provide faster relief and improved outcomes for patients who don't respond well to existing therapies.
What evidence suggests that this trial's treatments could be effective for ulcerative colitis?
Research has shown that upadacitinib, which participants in this trial may receive, effectively treats ulcerative colitis (UC). Studies have found that many patients achieve remission, with significant symptom improvement, within 8 to 16 weeks. In everyday use, patients have experienced a noticeable decrease in disease activity and symptoms over time. Upadacitinib has also demonstrated effectiveness comparable to infliximab, the standard care treatment arm in this trial, for hospitalized patients. Overall, this treatment offers a good balance of benefits and risks for people with moderate to severe UC over several years.36789
Are You a Good Fit for This Trial?
This trial is for hospitalized patients with a confirmed diagnosis of acute severe ulcerative colitis who haven't improved after at least three days on IV steroids. Participants must have had recent colonoscopy or sigmoidoscopy, be able to follow study procedures, and provide written consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Upadacitinib 45mg daily for at least five days, followed by infliximab in non-responders, or standard care with infliximab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Upadacitinib
Trial Overview
The study tests if using upadacitinib first, then infliximab for non-responders, is as effective as the standard treatment with infliximab alone in patients with steroid-refractory acute severe ulcerative colitis.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants will receive standard care, which is Infliximab.
Participants will receive Upadacitinib 45mg daily, once a day, for at least five days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
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
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.
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 ...
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.
4.
journals.lww.com
journals.lww.com/ajg/fulltext/2024/10001/s1387_real_world_efficacy_and_safety_outcomes.1388.aspxS1387 Real World Efficacy and Safety Outcomes Analysis ...
Upadacitinib demonstrates comparable efficacy & safety to infliximab in real-world hospitalized UC patients. While there was no significant difference observed ...
Comparative effectiveness of tofacitinib versus upadacitinib ...
Upadacitinib showed higher early response rates, but long-term outcomes were comparable for both. Implications for patient care. Tofacitinib and ...
Long-term efficacy and safety of upadacitinib in patients ...
The U-ACTIVATE long-term extension study aims to evaluate the long-term efficacy and safety of upadacitinib in patients with moderately to severely active ...
Real-World Effectiveness and Safety of Upadacitinib in ...
Steroid-free remission was achieved in 39% of patients at week 8. Upadacitinib results were unaffected by prior biologic or JAKi failure. Mean ...
DOP002 Efficacy and safety of upadacitinib after 4 years of ...
The long-term safety profile for UPA in pts with UC was consistent with previous analyses,1,2 with no new safety risks identified in the ongoing ...
or Third-Line Therapy in Patients with Ulcerative Colitis
The clinical remission and clinical response rates were 45.5% (92/202) and 63.5% (128/202), respectively, at 8 weeks and 60.2% and 81.7%, respectively, at the ...
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