Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.

Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients. - Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022104

Enrollment

Registered

2016-04-27

Start date

2016-04-27

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. Study design for predicting outcomes: Steroid dependent or moderate to severe UC patients who are decided to include ADA. 2. Study design for recurrence prediction: UC patients who have been treated with ADA as a maintenance therapy for over 12 week. 3. Patients are able to provide written informed consent after having received adequate explanation on the purpose of the study and the nature of the procedures involved. *In under age cases (below 20 years) consent from one of the patient's parents will be obtained. 4. Patients aged 16 years or older.

Exclusion criteria

Exclusion criteria: 1. Pregnant woman *Patients who become pregnant during study period to be required to discontinue the study 2. Patients unable to provide informed consent.

Design outcomes

Primary

Measure	Time frame
1. Study design for predicting outcomes: Evaluation of sensitivity, specificity of FC by comparing the remission rate at week 52 between patients with a decreased FC at 12 week and other patients who have been treated with ADA for 52 weeks. * Patients with a decreased FC at 12 week: Patients whose values of FC at 12w were <320 microgram/gram and their reduction rates were over 30% comparing to their FC values before ADA induction. 2. Study design for recurrence prediction: Comparison the value of FC in ADA inducting UC patients (over 12w) between patients who relapsed during following period (minimal following period: 9 month) and patients who did not.	—

Measure

Time frame

1. Study design for predicting outcomes: Evaluation of sensitivity, specificity of FC by comparing the remission rate at week 52 between patients with a decreased FC at 12 week and other patients who have been treated with ADA for 52 weeks. * Patients with a decreased FC at 12 week: Patients whose values of FC at 12w were <320 microgram/gram and their reduction rates were over 30% comparing to their FC values before ADA induction. 2. Study design for recurrence prediction: Comparison the value of FC in ADA inducting UC patients (over 12w) between patients who relapsed during following period (minimal following period: 9 month) and patients who did not.

—

Countries

Japan

Contacts

Public ContactTakako Miyazaki MD. PhD.

Hyogo College of Medicine Department of Inflammatory Bowel Disease, Division of Internal Medicine

takako35@hyo-med.ac.jp0798-45-6663

Outcome results