Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 785
- Locations
- 153
- Primary Endpoint
- Percentage of Participants Achieving Clinical Response (CR) per Partial Adapted Mayo Score Among those who Achieved CR at Completion of Upadacitinib Induction (either at Week 8 or at Week 16)
Study Overview
Brief Summary
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.
Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide.
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with a diagnosis of moderate to severe Ulcerative colitis (UC).
- •Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study.
- •Participants prescribed upadacitinib in accordance with the approved local label.
- •Participants able to understand and communicate with the investigator and comply with the requirements of the study.
- •Participants willing to continue with study documentation after cessation of upadacitinib.
- •Participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iPhone).
Exclusion Criteria
- •Participants with any contraindication to upadacitinib.
- •Participants previously exposed to upadacitinib in a clinical trial.
- •Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).
Outcomes
Primary Outcomes
Percentage of Participants Achieving Clinical Response (CR) per Partial Adapted Mayo Score Among those who Achieved CR at Completion of Upadacitinib Induction (either at Week 8 or at Week 16)
Time Frame: Week 52
Clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score \[RBS\] ≥ 1 or absolute RBS ≤ 1.
Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score
Time Frame: Up to approximately week 156
The first clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score \[RBS\] ≥ 1 or absolute RBS ≤ 1. Median time to achieve the first CR per partial adapted mayo score will be reported
Secondary Outcomes
No secondary outcomes reported