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. (UPlift)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05930275 |
|
Recruitment Status :
Recruiting
First Posted : July 5, 2023
Last Update Posted : May 7, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|
| Crohn's Disease |
| Study Type : | Observational |
| Estimated 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) |
| Actual Study Start Date : | February 19, 2024 |
| Estimated Primary Completion Date : | September 30, 2028 |
| Estimated Study Completion Date : | September 30, 2028 |
| Group/Cohort |
|---|
|
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.
|
- Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO) [ Time Frame: 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.
- 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930275
| Contact: Tanja Plath | tanja.plath@abbvie.com |
Show 36 study locations
| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT05930275 |
| Other Study ID Numbers: |
P23-899 |
| First Posted: | July 5, 2023 Key Record Dates |
| Last Update Posted: | May 7, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 |
|
Crohn's disease CD Upadacitinib |
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |