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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.

Sponsor
AbbVie (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05930275
Collaborator
(none)
1,200
Enrollment
61.5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multi-Country, Prospective, Post-Marketing Study of UPadacitinib Evaluating Speed of Onset and Durability of Effectiveness for Patients With Moderate to Severe Crohn's Disease for 3-years in Real-World Clinical Practice (UPlift)
    Anticipated Study Start Date :
    Aug 15, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2028
    Anticipated Study Completion Date :
    Sep 30, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    Upadacitinib

    Participants will receive upadacitinib as prescribed by their physician according to local label.

    Outcome Measures

    Primary Outcome Measures

    1. Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO) [Up to Week 12]

      Daily CR-PRO is a composite endpoint defined as the first day with at least 30% decrease in daily very soft or liquid stool frequency (SF) and/or >= 30% decrease in daily abdominal pain (AP) score and both not worse than baseline and a prospective 7-day average daily CR-PRO starting on the first day of daily CR-PRO; prospective 7-day average daily CR-PRO is defined as >= 30% decrease in average daily very soft or liquid SF and/or >= 30% decrease in average daily AP score and both not worse than baseline.

    2. Percentage of Participants Achieving Clinical Remission per Harvey Bradshaw Index (HBI) Among those with Clinical Response-Harvey Bradshaw Index (CR-HBI) at End of Induction Therapy [At Week 52]

      Clinical Remission is defined as HBI <= 4. Clinical Response is defined as HBI reduction >= 3 points from baseline. The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient reported (well-being, symptoms) and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores < 5 indicate clinical remission, 5 - 7 indicate mild disease activity, 8 - 16 indicate moderate disease activity, and 16 indicate severe disease activity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05930275
    Other Study ID Numbers:
    • P23-899
    First Posted:
    Jul 5, 2023
    Last Update Posted:
    Jul 5, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Crohn's disease
    CD
    Upadacitinib
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Jul 5, 2023