Is NCT05230173 recruiting in Aurora, CO?

Yes, NCT05230173 is currently recruiting participants at its Aurora, CO location. This ulcerative colitis clinical trial is actively enrolling qualified participants.

How do I join the ulcerative colitis clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Ulcerative Colitis Clinical Trial in Aurora, CO

About This Ulcerative Colitis Study in Aurora

The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis \[UC\]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.

Sponsor: University of California, San Diego

Who Can Participate

Inclusion Criteria

Male or nonpregnant, nonlactating females, ≥ 18 years of age.

An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider.

Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., TNFα antagonists, ustekinumab, vedolizumab) and small molecule inhibitors (e.g., Janus kinase inhibitors, ozanimod), including future TIMs that become commercially available during the conduct of the trial.

Dose of TIM should be stable for 3 or more months prior to qualifying endoscopy/radiology. No treatment escalation of TIM or addition of IMM, corticosteroid, or mesalamines after the qualifying endoscopy/radiology procedure up to randomization is permitted. Dose de-escalation after qualifying procedure is permissible at the discretion of the treating provider.

In corticosteroid-free symptomatic remission based on validated PROs (PRO2 score) and deemed to be experiencing no other IBD-related symptoms in the opinion of the treating provider. Includes patients who may be in medically induced remission (on index TIM); or surgically induced remission with post-op initiation of index TIM for prophylaxis and colonoscopy/imaging performed at least 3 months after initiation/optimization of TIM showing moderate-severe bowel inflammation. Validated PROs are defined as:

CD: PRO2 (2-item patient reported outcome) mean daily score of abdominal pain score ≤1 and stool frequency score ≤ 3; or

UC: PRO2, with absence of rectal bleeding (rectal bleeding score = 0) and with stool frequency score ≤1.

Evidence of moderate to severe bowel inflammation on local reading of colonoscopy, flexible sigmoidoscopy, balloon-assisted enteroscopy, capsule endoscopy or MR, CT enterography, or intestinal ultrasound, performed within 6 months prior to screening, defined at the investigator's discretion or as follows:

CD: Colonoscopy showing moderately to severely active inflammation based on 1 of the following variables/scores:

Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 or score ≥4 for those with isolated ileal disease, or

Presence of mucosal ulcers \>5 mm in size if SES-CD has not been recorded, or

Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) score ≥2, or

Rutgeerts score i2b or higher for patients in surgically induced remission with post-operative endoscopic recurrence \[Note, either SES-CD or Rutgeerts score can be used for participants with post-operative recurrence\]; or

CD: MRE or CTE showing moderately to severely active inflammation based on 1 of the following variables:

Increased bowel wall thickness, or

Mural hyperenhancement, or

Peri-enteric fat stranding, or

Radiographic features of ulceration, or

Intramural T2 signal on fat suppressed images; or

CD: Capsule endoscopy showing moderately to severely active small bowel disease based on Lewis score \>790 (in case the disease is not accessible via endoscopy), or per local endoscopist if Lewis score is not reported; or

CD: Gastrointestinal ultrasound showing at least 1 of the following variables:

Increased bowel wall thickness \>5 mm, or

Color doppler score \>5/cm2, or

Bowel stenosis, or

Bowel stratification, or

Fatty wrapping; or

UC: modified MES score of 2 to 3, or documentation of any endoscopic feature that would define an MES of 2 to 3 (e.g., friability, ulceration, spontaneous bleeding, complete loss of vascular pattern), if an MES has not been recorded.

Eligible to receive at least 1 alternative TIM (excluding their index TIM) for the treatment of their disease per approved drug label, based on clinical and reimbursement guidelines.

Able to participate fully in all aspects of this clinical trial.

Informed consent must be obtained and documented.

Exclusion Criteria

Presence of ostomy or ileoanal pouches.

Serious underlying disease other than UC or CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.

History of alcohol or drug abuse or any other medical or health condition that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.

Prior enrolment in the current study.

Mild endoscopic disease activity, where treating providers would not consider switching TIM.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT05230173) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Ulcerative Colitis Treatment Options in Aurora, CO

If you're searching for ulcerative colitis treatment options in Aurora, CO, this clinical trial (NCT05230173) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced ulcerative colitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ulcerative colitis clinical trials near you to find additional studies recruiting in your area.

Ulcerative Colitis Clinical Trial in Aurora, CO

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