Ustekinumab for Crohn's Disease and Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if individuals with Crohn's disease or ulcerative colitis in deep remission can take ustekinumab less frequently without losing their response. Ustekinumab reduces inflammation in these conditions. Participants will switch from receiving the drug every 4 weeks to every 8 weeks, or from every 8 weeks to every 12 weeks, while researchers monitor their health. The trial seeks individuals in deep remission who are not taking steroids and can visit the clinic every 12 weeks. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you are not on corticosteroids or more than one biologic drug. It's best to discuss your specific medications with the trial team.
What is the safety track record for this treatment?
Research shows that ustekinumab is generally well-tolerated for treating Crohn’s disease and ulcerative colitis. Studies with patients over several years have found that ustekinumab is safer than a placebo. Specifically, safety data collected over five years for Crohn’s disease and four years for ulcerative colitis support this finding. These studies found that the treatment did not cause significant side effects, making it a safe option for many patients. Therefore, those considering joining a clinical trial for ustekinumab can rely on existing evidence suggesting that the treatment is generally safe.1234
Why are researchers enthusiastic about this study treatment?
Ustekinumab is unique because it targets specific proteins in the immune system, namely interleukin-12 and interleukin-23, which play a role in inflammation associated with Crohn's disease and ulcerative colitis. Unlike standard treatments such as corticosteroids or TNF inhibitors, ustekinumab offers a different mechanism of action that may provide relief for patients who don't respond well to other therapies. Researchers are excited about ustekinumab's potential to offer a more targeted approach, which could result in fewer side effects and improved outcomes for patients with these challenging conditions.
What is the effectiveness track record for ustekinumab in treating Crohn's disease and ulcerative colitis?
Research has shown that ustekinumab effectively treats Crohn's disease and ulcerative colitis. In one study, over 70% of Crohn's disease patients were symptom-free by week 56. Another study found that nearly 74% of patients were symptom-free by 12 months. For ulcerative colitis, 58.9% of patients had normal lab tests by week 16. This trial will evaluate different dosing schedules of ustekinumab, with some participants receiving it every 4 weeks and others every 8 weeks. These findings suggest that ustekinumab can help control symptoms, supporting its use for adjusting doses.5678
Are You a Good Fit for This Trial?
This trial is for individuals with Crohn's Disease or Ulcerative Colitis who are in clinical and endoscopic remission, not using corticosteroids. Women must either be unable to have children or use reliable birth control. Participants must also give informed consent and be in biochemical remission.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo de-escalation of ustekinumab therapy, changing dosing from every 4 weeks to every 8 weeks or from every 8 weeks to every 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ustekinumab
Trial Overview
The study tests if patients can maintain remission when the dose of Ustekinumab (UST) is reduced from every 4 weeks to every 8 weeks, or from every 8 weeks to every 12 weeks. It monitors UST blood levels, inflammation markers, and intestinal health during less frequent dosing.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Janssen Inc.
Industry Sponsor
Citations
Short-Term Effectiveness of Ustekinumab in Crohn's Disease
A real-world study in Spain reported that the clinical remission rates of ustekinumab treatment for CD at the 8th and 14th weeks were 47% and 58 ...
A Phoenix retrospective Cohort Study | Crohn's & Colitis 360
This study included 36% bio-naïve patients and showed that the remission and response rates were over 70% and 80%, respectively, at week 56 in ...
Ustekinumab in Ulcerative Colitis: A Real-Life ...
Biochemical remission was observed in 58.9% (56/95) of patients at week 16 and 48.2% (41/85) at week 52, although these outcomes were limited by missing data ( ...
Real-world effectiveness and safety of ustekinumab in bio ...
Two-thirds (67.7%) of patients achieved the primary outcome of clinical remission by Month 6 following ustekinumab initiation. By Month 12, 73.7 ...
Safety of Ustekinumab in Inflammatory Bowel Disease
The final cumulative ustekinumab safety data through 5 years in CD and 4 years in UC demonstrated favourable safety compared to placebo.
Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled ...
We present the final cumulative safety data from pooled ustekinumab IBD phase 2/3 clinical studies through 5 years in Crohn's disease [CD] and 4 years in ...
Long-term safety of ustekinumab in Crohn's disease
Data for 878 patients with Crohn's disease who received ustekinumab (mean follow-up 37.8 months), were included (median age 37.4 years, 58.9 % ...
8.
gastroenterologyadvisor.com
gastroenterologyadvisor.com/news/ustekinumab-safety-profile-favorable-long-term-in-ibd/Ustekinumab Safety Profile Is Favorable Over Long Term in ...
The ustekinumab safety profile was favorable for treating Crohn disease and ulcerative colitis through 5 and 4 years, respectively.
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