UC Bio Study

JRCT ID: jRCT1031200329

Registered date:28/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 18/05/2021
• Target sample size: 231
• Study type: Interventional

Intervention(s)

Infliximab:Infliximab (5 mg / kg / body weight) is infused intravenously at 0, 2, 6, 14, and 22 weeks.
Vedolizumab:Intravenous infusion of vedolizumab 300 mg at 0, 2, 6, 14, and 22 weeks
Ustekinumab: a single intravenous infusion of the dose shown below is given at the first induction therapy.
Body weight dose
55kg or less 260mg
55-85kg 390mg
85kg or more 520mg

After 8_weeks of intravenous drip infusion, 90 mg of ustekinumab is usually subcutaneously administered to adults, and 90 mg is subcutaneously administered at 12-week intervals thereafter. If the effect is diminished, the dosing interval can be shortened to 8 weeks.

Outcome(s)

• Primary Outcome: Clinical remission rate at Week 12

Secondary Outcome

1 Clinical response rate at Week 12
2 Endoscopic remission rate at Week 12
3 Complete endoscopic remission at Week12
4 Histological remission at Week 12
5 The rate of fecal calprotectin level less than 150ng/g at Week 12
6 Clinical remission rate at Week 2
7 The rate of no appearance of blood in stool at Week 12
8 Significance of Patients report outcome from Week 0 to Week 2 and Week 12
9 Significance of Mayo subscore (blood in stool) from Week 0 to Week 2 and Week 12
10 Significance of Mayo subscore (number of daily stool) from Week 0 to Week 2 and Week 12
11 Significance of Mayo endoscopic subscore from Week 0 to Week 12
12 Significance of fecal calprotectin level from Week 0 to Week 12

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who meet the criteria of the ulcerative colitis diagnostic criteria (revised in 2018) of the Ministry of Health, Labor and Welfare Specified Disease or Intractable Inflammatory Intestinal Disorders Research Group
2) Patients with steroid resistance / dependence at the time of registration or who have previously received systemic steroids
3) Patients who have never used antiTNFa antibody preparations, ustekinumab, or vedolizumab
4) Patients with a Mayo score of 6 points or higher and an endoscopic Mayo score of 2 or higher at the time of registration (Endoscopic scores at the enrollment were assessed by local institutional endoscopists)
5) Patients who are 16 years of age or older at the time of obtaining consent and who have obtained written consent from the patient. For patients with age of 16-19, patients who have obtained the written consent of the person and the substitute
6) Those who have received sufficient explanation before participating in this study, and who have obtained the document for contents after sufficient explanations. For minors, those who have obtained the written consent of the person and the substitute
Definition of steroid resistance The failure to respond to systemic steroid treatment at a dose of 1 to 1.5mg per kg per day for 1 week.
Definition of steroid dependence Either an inability to reduce steroids below the equivalent dose of prednisolone 10 mg per day within 3 months of starting steroid therapy without recurrent active disease, or relapse within 3 months of cessation of steroid therapy.

Exclude criteria

1) Patients classified as fulminant in the clinical severity classification
2) Patients who are suspected of having colitis rather than ulcerative colitis (infectious enteritis, etc.)
3) Patients with symptomatic gastrointestinal stricture
4) Patients who areplanning colectomy for UC
5) Pregnant women or patients who may be pregnant, lactating patients or those who wish to become pregnant during the study period
6) Patients with contraindications to use infliximab, ustekinumab, or vedolizumab in the package insert
7) Patients who the doctor in charge deems inappropriate to be included in this study
8) Patients participating in clinical trials of other medications
9) Excluding criteria for concomitant medication as below;
1 Patients who have increased the dose of oral 5-aminosalicylic acid within 2 weeks before the registration.
2 Patients who have newly started the enema or suppository treatment with 5-aminosalicylic acid or steroids within 1 week before the registration.
3 Patients receiving oral prednisolone (or equivalent corticosteroid) or intravenous corticosteroid in excess of 30 mg /day within 2 weeks before the registration. In addition, patients who are receiving 30mg daily dose or less of oral or intravenous corticosteroids and whose dosage is not constant within 2 weeks.
4 Patients who newly started thiopurine (azathioprine / 6-mercaptopurine) within 8 weeks before the registration. Patients whose dose of thiopurine was changed within 2 weeks before registration in patients who already received thiopurine.
5 Patients receiving cyclosporine or tacrolimus within 4 weeks before the registration.
6 Patients receiving carotegrastmethyl,upadacitinib,filgotinib or tofacitinib within a week before the registration.
7 Patients receiving apheresis therapy within 4 weeks before the registration. tofacitinib

Related Information

• Primary Sponsor: Naganuma Makoto
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Division of Gastroenterology and Hepatology, Kansai Medical University