A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease.

Phase 3

• Conditions: Crohn's disease; D003424

• Registration Number: JPRN-jRCTs021200013
• Lead Sponsor: Moroi Rintao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Japanese Crohn's disease

From moderate to severe activity
(CDAI > 220)

Performance Status:0-2

Outpatient (Around 1 week admission is permitted).

Exclusion Criteria

With stoma.

With surgical lesion such as stenosis or abscess.

Inpatient with intravenous hyperalimentation.

History of allergy for Ustekinumab or Budesonide.

Woman with pregnancy, possibility of pregnancy. Woman who is within 28 days after postpartum, or gives the breast to a child.

With psychiatric disorder

Within 5 years after diagnosis or treatment of malignant tumor.

Patient who has active infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified