Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication

Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication - ASPECT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051508

Enrollment

203

Registered

2023-07-03

Start date

2023-06-21

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

Ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who were enrolled in the CT3 Trial 2. Patients at sites that agreed to participate in the trial

Exclusion criteria

Exclusion criteria: 1. Patients who have declined to participate in the trial

Design outcomes

Primary

Measure	Time frame
Correlation between the Mayo endoscopic score (MES) and biomarkers (LRG, anti-integrin alpha(v) beta(6) antibody titer) at the end of treatment	—

Secondary

Measure	Time frame
1) MES-biomarker correlation at each time point 2) Comparison of change over time in biomarkers between patients who did and did not achieve remission 3) Use of Biomarkers for Predicting Response and Exploring End-of-Treatment Criteria 4) Comparison of change in course of recovery from bloody stool and normalization of bowel movement frequency between placebo group and active drug group 5) Assessment of bloody stool/bowel movement status after 1, 2, 3, 4, 5, and 6 weeks of treatment, and effect on mucosal score at Week 8 6) Correlation between laboratory values (e.g., FCP, CRP) and biomarkers 7) Correlation between biomarkers and duration of remission	—

Measure

Time frame

1) MES-biomarker correlation at each time point 2) Comparison of change over time in biomarkers between patients who did and did not achieve remission 3) Use of Biomarkers for Predicting Response and Exploring End-of-Treatment Criteria 4) Comparison of change in course of recovery from bloody stool and normalization of bowel movement frequency between placebo group and active drug group 5) Assessment of bloody stool/bowel movement status after 1, 2, 3, 4, 5, and 6 weeks of treatment, and effect on mucosal score at Week 8 6) Correlation between laboratory values (e.g., FCP, CRP) and biomarkers 7) Correlation between biomarkers and duration of remission

—

Countries

Japan

Contacts

Public ContactSaiko Tamura

Satt Co.,Ltd Clinical Research Promotion Group

ct3ret@sa-tt.co.jp03-5312-5026

Outcome results