A 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-jRCT1080225069

Enrollment

152

Registered

2020-02-13

Start date

2020-08-19

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's disease

Interventions

investigational material(s) Generic name etc : Biologics for the treatment of Crohn's disease INN of investigational material : - Therapeutic category code : 239 Other agents affecting digestive organ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Female or male patient with a confirmed diagnosis of moderately to severely active CD and treated by a biologic 2.Patient aged >=20 years at the time of CD diagnosis 3.Female or male patient medically treated for CD 4.Patient aged >=20 years at the time of CD diagnosis

Exclusion criteria

Exclusion criteria: 1.Patient enrolled in an interventional inflammatory bowel disease clinical trial 2.Patient's medical chart is empty or missing 3.Patient who refuse to provide her or his medical information.

Design outcomes

Primary

Measure	Time frame
other Proportion of patients with a digital twin match in the virtual patients' library Time Frame: Baseline and Week 14, 26, 52 and 104 after a biologic treatment initiation other Proportion of correct predictions across biomarkers, clinical outcomes, endoscopic images and treatment sequences dimensions Time Frame: Baseline and Week 14, 26, 52 and 104 after a biologic treatment initiation	—

Secondary

Measure	Time frame
efficacy Changes in CDAI, CDEIS and SES-CD scores from baseline to week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Baseline and Week 14, 26, 52 and 104 after a biologic treatment initiation CDAI, CDEIS and SES-CD scores are used to assess Crohn's disease activity, with higher scores indicating more severe disease. efficacy Proportion of patients achieving endoscopic mucosal healing at week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The endoscopic mucosal healing is defined as absence of ulceration. efficacy Proportion of patients achieving endoscopic response at week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The endoscopic response is defined a >= 50% improvement from the baseline in SES-CD. efficacy Proportion of patients achieving clinical response at week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The clinical response is defined as a >= 100-point decrease in CDAI score from the initiation of biologics. efficacy Proportion of patients achieving clinical remission at week14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The clinical remission is defined as CDAI score of =< 150. efficacy Proportion of patients achieving a corticosteroids free remission at week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The corticosteroids free remission is defined as the clinical remission with corticosteroid-free, though corticosteroids were used at the initiation of biologics. safety Proportion of patients switching from a biologic treatment to another one Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initi	—

Measure

Time frame

efficacy Changes in CDAI, CDEIS and SES-CD scores from baseline to week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Baseline and Week 14, 26, 52 and 104 after a biologic treatment initiation CDAI, CDEIS and SES-CD scores are used to assess Crohn's disease activity, with higher scores indicating more severe disease. efficacy Proportion of patients achieving endoscopic mucosal healing at week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The endoscopic mucosal healing is defined as absence of ulceration. efficacy Proportion of patients achieving endoscopic response at week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The endoscopic response is defined a >= 50% improvement from the baseline in SES-CD. efficacy Proportion of patients achieving clinical response at week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The clinical response is defined as a >= 100-point decrease in CDAI score from the initiation of biologics. efficacy Proportion of patients achieving clinical remission at week14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The clinical remission is defined as CDAI score of =< 150. efficacy Proportion of patients achieving a corticosteroids free remission at week 14, 26, 52 and 104 after a biologic treatment initiation Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initiation The corticosteroids free remission is defined as the clinical remission with corticosteroid-free, though corticosteroids were used at the initiation of biologics. safety Proportion of patients switching from a biologic treatment to another one Timeframe: Week 14, 26, 52 and 104 after a biologic treatment initi

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026