A supplemental retrospective chart review to evaluate a personalized predictive digital Crohn's disease computational model

A supplemental retrospective chart review to evaluate a personalized predictive digital Crohn's disease computational model - A supplemental retrospective chart review to evaluate a personalized predictive digital Crohn's disease computational model

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046462

Enrollment

Registered

2021-12-27

Start date

2022-01-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with a confirmed diagnosis of moderately to severely active CD and started treatment with either vedolizumab or ustekinumab between May 29, 2017 and August 31, 2021, inclusive. 2. Patients aged >=20 years at the time of CD treatment initiation with either vedolizumab or ustekinumab.

Exclusion criteria

Exclusion criteria: 1.Patients who participated in prospective interventional clinical trials of inflammatory bowel disease. 2. Patients with empty or missing medical records. 3. Patients who refuse to provide his or her medical information.

Design outcomes

Primary

Measure	Time frame
To evaluate a personalized predictive digital CD computational model for adult CD patients. To measure the accuracy of the predictions for longitudinal individual-level patient data.	—

Secondary

Measure	Time frame
To characterize subjects treated with a biologic treatment in terms of demographics, medical, surgical and treatment histories, and disease features. To describe treatment patterns associated with the use of a biologic treatment (e.g., initial dose, dose escalation, treatment discontinuation, and switching). To describe the real-world clinical, biological and endoscopic effectiveness and safety of biologic treatments in biologic naive and biologic non-naive subjects.	—

Measure

Time frame

To characterize subjects treated with a biologic treatment in terms of demographics, medical, surgical and treatment histories, and disease features. To describe treatment patterns associated with the use of a biologic treatment (e.g., initial dose, dose escalation, treatment discontinuation, and switching). To describe the real-world clinical, biological and endoscopic effectiveness and safety of biologic treatments in biologic naive and biologic non-naive subjects.

—

Countries

Japan

Contacts

Public ContactKeisuke Nakatome

Takeda Pharmaceutical Company Limited Japan Medical Office

DL.MRE.GI.Team@takeda.com090-1891-6957

Outcome results