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Ustekinumab withdrawal for ulcerative colitis in remission

Ustekinumab withdrawal for UC in remission

4

Four patients were enrolled in the Ustekinumab maintenance group. Age/gender at the time of study registration: 26 years/female, 50 years/male, 42 years/male, 57 years/male; partial Mayo score 0, 1, 2, 1, respectively. The induction dates for ustekinumab were 2022/1/26, 2021/10/7, 2020/11/27, and 2020/5/29, respectively.

Although we tried to recruit patients to attend this study, we were unable to obtain their consent to participate in the Ustekinumab discontinuation group, and 4 patients in a row were entried in the maintenance group. Due to the diversification of drug selection, the number of target patients is lower than previously expected. Due to the current situation, it was considered that there was no sufficient prospect of participation in the Ustekinumab discontinuation group.

No adverse events were observed among study participants.

No evaluation or analysis will be performed as there was no registration in the Ustekinumab discontinuation group.

This study was discontinued because no participants enrolled.

April. 19, 2024

No

not applicable

https://jrct.mhlw.go.jp/latest-detail/jRCTs021210073

Shimodaira Yosuke

Akita University Hospital

44-2 Hiroomote-aza Hasunuma, Akita city

yosuke.shimodaira@med.akita-u.ac.jp

Shimodaira Yosuke

Akita University Hospital

44-2 Hiroomote-aza Hasunuma, Akita city

+81-18-884-6104

yosuke.shimodaira@med.akita-u.ac.jp

Complete

Mar. 08, 2022

Interventional

single arm study

open(masking not used)

active control

parallel assignment

treatment purpose

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

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

Both

Ulcerative colitis

No maintenance subcutaneous Ustekinumab therapy for UC patients in remission with Ustekinumab.

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

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

+81-18-884-6461

Feb. 01, 2022

none