Ustekinumab withdrawal for UC in remission

JRCT ID: jRCTs021210073

Registered date:08/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 08/03/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): No maintenance subcutaneous Ustekinumab therapy for UC patients in remission with Ustekinumab.

Outcome(s)

Primary Outcome

1.Relapse of ulcerative colitis 2 years after discontinuation of Ustekinumab
2.Remission by re-induction therapy
with Ustekinumab i.v.

Secondary Outcome

1.pMayo score, CRP, and serum concentration of Ustekinumab and cytokines at 0, 8, 24, 56, 104 weeks after initiation of this study
2.Safety

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1)Subjects clinically, endoscopically, and pathologically confirmed as ulcerative colitis
2)Subjects who relapsed*1 under maintenance therapy with either 5-ASA or azathioprine, or were dependent*2 for steroid.
3)Subjects remission*3 with Ustekinumab at 8 weeks after i.v. or who were in remission with Ustekinumab maintenance therapy.
4)15 - 74 years old at the time of gained for informed consent
5)Subjects gained consent himself in writing for participation of this study

*1 increased 3 or more than 3 in Mayo score and increased endoscopic subscore
*2 Relapsed in steroid tapering phase or after the off of steroid.
*3 Two or less than two in Mayo score and one or less than one in all subscores

Exclude criteria

1)Subjects who underwent colectomy
2)Subjects who were intolerant for 5-ASA and azathioprine
3)Pregnant women, subjects who may be pregnant, within 28 days from giving birth or ongoing breastfeeding.
4)Subjects with serious complications
5)Subjects with active infection
6)Subjects with severe psychiatric disorders
7)Subjects participating in other clinical study on other medicines and medical devices
8)Subjects who disagree to participate the study
9)Subjects were judged inappropriate by investigators

Related Information

• Primary Sponsor: Shimodaira Yosuke