UPlift

Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.

Brief summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world. 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. Study visits may be conducted on-site or virtually as per standard of care.

Observational study

Status:
Recruiting
Conditions:
Crohn's Disease
Enrollment:
1200 patients
Protocol ID:
P23-899
Observational model:
Cohort
Time perspective:
Prospective

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
Yes, please contact me

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- A diagnosis of moderate-to-severe crohn's disease (CD).

- 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.

- Able to understand and communicate with the investigator and comply with the
requirements of the study.

- Willing to continue with study documentation after cessation of upadacitinib.

Exclusion Criteria:

- Any contraindication to upadacitinib.

- Previously exposure to upadacitinib in a clinical trial.

- Currently participating in interventional research (not including non-interventional
study, post-marketing observational study (PMOS) , or registry participation).

- Initiation of upadacitinib prior to enrollment.

All the cities where the clinical studies are located

North York - M6A 3B4