A Study on Infections in Adults With Ulcerative Colitis/Crohn's Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>=2 medical (for Medicare FFS, Part A/B) claims, at least 30 days apart, with an ICD-10-CM code for UC during the baseline period or on the Index Date.
Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.
>=2 medical (for Medicare FFS, Part A/B) claims, at least 30 days apart, with an ICD-10-CM code for CD during the Baseline Period or on the Index Date.
Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.
Disqualifiers
Any evidence of AMT utilization during the Baseline Period.
Participants with at least 2 ICD-10-CM codes for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, non-infectious uveitis, or psoriatic arthritis during the Baseline Period.
Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.
Trial population
United States (US) adult participants diagnosed with UC or CD who initiated ENTYVIO or other AMTs will be included in this study.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
No intervention
Other interventionThis is an observational study, no intervention will be administered.
Treatment groups
23,900 Participants
are divided into 2 treatment groupsGroup A: Participants with UC1 intervention
Group B: Participants with CD1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Hospitalized Due to Serious Infections
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 monthsSecondary outcomes
1
Percentage of Participants with Non-serious Infections
Non-serious infections will include any primary diagnosis of infection that is not associated with hospitalization.
Time frame
Up to 4 months Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: