None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Preparation of Ustekinumab Intravenous Injection(IV) and Administration Methods of Ustekinumab Intravenous Injection(IV) and Subcutaneous injection(SC) will be ca
more than 85 kg: 520 mg [4 vials]).
At week 0, subjects were randomized 1:1 to the dose-intensification regimen group and standard-dose regimen groups. Afterwards, subcutaneous ustekinumab administrat
Sponsors
Yeongnam University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 19 to under 75 years old 2) Patients with luminal Crohn’s disease 3) Patients who do not respond with at least one TNF inhibitor for Crohn's disease treatment or experience loss of response during maintenance therapy 4) Patients with moderate-to-severe Crohn's disease with a CDAI score between 220 and 450 at the screening visit 5) Patients with ileocolonic Crohn’s disease with SES-CD =6 or ileal or colonic Crohn’s disease with SES-CD =4 and at least one segment showing an ulcer score of 1 or higher 6) Patients at the screening visit with biochemical test results satisfying Fecal calprotectin = 250 µg/g or CRP = 0.5 mg/dL 7) Patients who have voluntarily provided written informed consent for participation in this clinical trial
Exclusion criteria
Exclusion criteria: 1) Patients with prior experience in treatment with biologics targeting IL-12 and/or IL-23 2) Patients with a history of hypersensitivity to humanized proteins 3) Patients who have been taking corticosteroids within 8 weeks prior to the screening 4) Patients with active tuberculosis - However, patients with a past history of tuberculosis who have completed tuberculosis treatment according to standard guidelines and have been declared cured are eligible 5) Patients with latent tuberculosis - However, patients with latent tuberculosis who have completed 3 weeks of treatment or who will complete treatment for latent tuberculosis in the future are eligible 6) Patients who are positive for hepatitis B surface antigen (HBsAg) - Even if the hepatitis B surface antigen is negative, if the patient is positive for hepatitis B core antibody (IgG anti-HBc), they must undergo HBV DNA testing (real-time quantitative PCR). If the HBV DNA test result is =10 IU/mL, they should be excluded 7) Patients who are positive for antibodies against hepatitis C virus (HCV) 8) Patients with a history of or who are positive for HIV infection (as confirmed by history taking) 9) Patients with NYHA Class III/IV heart disease 10) Patients with a history of serious infections, malignancies (except basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma) within the past 5 years, or a history of dysplasia of the colon or small intestine within the past 5 years 11) Pregnant or breastfeeding women 12) Women of childbearing potential who are not using appropriate contraception or do not plan to use appropriate contraception during the trial and for 6 months after the last dose of ustekinumab (aoral, injectable, or implantable hormonal contraceptives, diaphragms, condoms, intrauterine devices or abstinence are considered appropriate methods of contraception) 13) Patients with severe complications at the screening visit, including: - Toxic megacolon, intra-abdominal abscess, small inestinal or colon stenosis, fulminant colitis. 14) Patients who received a live vaccine within 3 months prior to screening 15) Patients deemed by the investigator to be unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical remission | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical remission rate;clinical response rate;endoscopic response;endoscopic mucosal healing rate;Assessment of biochemical parameter(Albumin);Assessment of biochemical parameter(CRP/Fecal calprotectin);Assessment of Ustekinumab serum level and antibody production;Safety assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactHa Lin Kwon
Yeongnam University Medical Center
Outcome results
None listed