None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Preparation of Ustekinumab IV and Administration Methods of Ustekinumab IV and SC will be carried out according to the approved guidelines.
All participants will
more than 85 kg: 520 mg [4 vials]).
For Ustekinumab IV administration, vital signs (V/S: blood pressure, pulse rate, respiratory rate, body temperature) will be checked at baseline and every 30 minute
Sponsors
Asan 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 adequately to or are intolerant to conventional therapeutic agents such as corticosteroids, 6-mercaptopurine, or azathioprine, or for whom these agents are contraindicated. 4) Patients who do not respond to, show insufficient response to, exhibite intolerance to, or experience loss of response during maintenance therapy with at least one TNF inhibitor for Crohn's disease treatment 5) Patients with moderate-to-severe Crohn's disease with a CDAI score between 220 and 450 at the screening visit 6) 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 7) Patients at the screening visit with biochemical test results satisfying Fecal calprotectin = 250 µg/g or CRP = 0.5 mg/dL 8) 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 who have been exposed to biologics or small molecule drugs (including investigational drugs) other than TNF inhibitors 3) Patients with a history of hypersensitivity to humanized proteins 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, untreated intra-abdominal abscess, untreated perianal abscess, symptomatic small inestinal or colon stenosis, symptomatic bowel-bowel fistula, fulminant colitis. However, patients may be enrolled if : at baseline, patients with intra-abdominal abscess can be registered if it has been more than 8 weeks since start of appropriate drainage, and patients with perianal abscess can be registered if it has been more than 4 weeks since the start of appropriate drainage 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 |
|---|---|
| Proportion of subjects achieving clinical remission;Proportion of subjects achieving endoscopic response | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic mucosal healing rate;Clinical remission rate;Clinical response rate;Corticosteroid-free clinical remission rate;Corticosteroid-free clinical response rate ;CRP assessment;Fecal calprotectin assessment;Ustekinumab blood concentration and antibody production assessment;Safety assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactByoung Duk Ye
Asan Medical Center
Outcome results
None listed