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

JRCT ID: jRCTs021200013

Registered date:31/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Crohn's disease
• Date of first enrollment: 28/02/2018
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Ustekinumab monotherapy for 32 weeks.

Outcome(s)

• Primary Outcome: The remission rate at 8 weeks.

Secondary Outcome

The maintaining remission rate at 32 weeks after the start of treatment.
The responder rate at 8 and 32 weeks after the start of treatment.
The score of C reactive protein and albumin at 8 and 32 weeks after the start of treatment.
The rate of mucosal healing at 8 and 32 weeks after the start of treatment.
The rate of side effects.
The relationship between clinical factors at baseline and clinical effects of Ustekinumab and Budesonide.
The concentration of cytokine(i.e.TL1A, IL12) and anti Ustekinumab antibody.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

Japanese Crohn's disease

From moderate to severe activity
(CDAI > 220)

Performance Status:0-2

Outpatient (Around 1 week admission is permitted).

Exclude 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.

Related Information

• Primary Sponsor: Moroi Rintao
• Secondary ID(s): UMIN000030884