Takeda Site
Cambridge, Massachusetts, 02142, United States
NCT Number: NCT07250815
More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Medicines that treat UC/CD, however, might make it easier for older adults to get infections.
The main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).
The study will include people aged 65 years and older UC or CD who used either ENTYVIO with ustekinumab or a TNF-alpha inhibitor between 2016 and 2025.
Data will be collected from existing Medicare databases.
Trial opening soon.
Get Notified65 year and older
All sexes
Observational
Cambridge, Massachusetts, 02142, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
UC Study Cohort:
Participants will be included if they had:
-Greater than or equal to (>=) 1 medical (for Medicare fee-for-service [FFS], Part A/B) or pharmacy claim (for Medicare FFS, Medicare Part D) for an approved AMT for UC during the participant identification period.
Note: Claim should be on or after the food and drug administration (FDA) treatment-specific approval dates for each drug.
The date of the first claim during the participant identification period will be designated the Index Date, and the corresponding AMT, the index AMT.
CD Study Cohort:
Participants will be included if they had:
Note: Claim should be on or after the FDA treatment-specific approval dates for each drug.
The date of the first claim during the Patient Identification Period will be designated the Index Date, and the corresponding AMT, the index AMT.
If a participant has both a UC and CD diagnosis during the baseline period or on the index date, the diagnosis most proximate to or on the index date will be used to categorize the participant as having UC or CD.
Exclusion criteria
Participants with any of the following will be excluded from the analysis:
This is an observational study, no intervention will be administered.
Time frame: Up to 4 months
Serious infections will include infections of the respiratory tract, skin and soft tissue, genitourinary tract, gastrointestinal tract, central nervous system, and septicemia/sepsis. The intraabdominal infections, perianal infections, tuberculosis, and other opportunistic infections will not be considered under serious infection requiring hospitalization.
Time frame: Up to 4 months
Non-serious infections will include any primary diagnosis of infection that is not associated with hospitalization.
Contact information is provided by the study sponsor or research team.
Takeda
Industry
Infection Outcomes Among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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