Magnifying endoscopy trial to evaluate the effects of adalimumab on mucosal healing in Crohn's disease with special reference to Peyer's patches

Magnifying endoscopy trial to evaluate the effects of adalimumab on mucosal healing in Crohn's disease with special reference to Peyer's patches - Magnifying endoscopy, adalimumab and mucosal healing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016014

Enrollment

120

Registered

2015-01-01

Start date

2015-01-01

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

Patients achieving mucosal healing with magnifying endoscopy Patients achieving mucosal healing with conventional endoscopy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients ranging 16 to 75 years of age who have active Crohn's disease that is indicated for the treatment with Humira using the recommended dosing regimens. Patients who have or not undergone anti-TNF alpha antibody therapy. Patients who can undergo the conventional and magnifying endoscopy at baseline and weeks 12 and 52.

Exclusion criteria

Exclusion criteria: severe infection active tuberculosis demyelinating disease congestive heart failure enteral nutrition with more than 1200 kcal primary failure with infliximab administration of investigational new drug within 24 weeks unsettled treatment with antibiotics, azathioprine, mercaptoprine, methotrexate within 28 days and with steroids within 14 days treatment with prednisolone at more than 40 mg dose, cyclosporine, tacrolimus, alkylating agaents leukocytoapheresis within 8 weeks aritifical anus and ileoanal pouch severe stricture, fistula and abcess total parenteral or entral nutrition exclusion by responsible persons

Design outcomes

Primary

Measure	Time frame
Percentage of patients who achieved endoscopic remission The percentage of patients who achieved CE remission at week 52 will be calculated for subgroups of patients who achieved ME remission and CE remission at week 12.	—

Secondary

Measure	Time frame
Percentages of patients who achieved ME remission at weeks 12 and 52 Percentages of patients who achieved CE remission at weeks 12 and 52 Percentages of patients who achieved ME remission and a CDAI score of <150 at weeks 12 and 52 Endoscopic assessment of colonic segments other than terminal ileum (SES-CD) at weeks 12 and 52 Rates of all-cause hospitalization and CD-related hospitalization by week 52 in patients who achieved ME remission and those who achieved CE remission only. Correlations between clinical remission (CDAI/HBI), inflammatory response (CRP, etc.) and ME remission (normalization of PP structure).	—

Measure

Time frame

Percentages of patients who achieved ME remission at weeks 12 and 52 Percentages of patients who achieved CE remission at weeks 12 and 52 Percentages of patients who achieved ME remission and a CDAI score of <150 at weeks 12 and 52 Endoscopic assessment of colonic segments other than terminal ileum (SES-CD) at weeks 12 and 52 Rates of all-cause hospitalization and CD-related hospitalization by week 52 in patients who achieved ME remission and those who achieved CE remission only. Correlations between clinical remission (CDAI/HBI), inflammatory response (CRP, etc.) and ME remission (normalization of PP structure).

—

Countries

Japan

Contacts

Public ContactHajime Isomoto

Nagasaki University Hospital Endoscopy

hajimei2002@yahoo.co.jp095-819-7336

Outcome results

None listed

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

Magnifying endoscopy trial to evaluate the effects of adalimumab on mucosal healing in Crohn&#39;s disease with special reference to Peyer&#39;s patches