None listed
Conditions
Interventions
Drug : Patients with Crohn's disease will given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every other week. At week 30. patient
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 18 years or oder 2) Moderate to severe Crohn's disease (Crohn's disease activitn index 220 to 450) 3) Ileocolonic CD with Simple Endoscopic Score for Crohn Disease =6 or ileal or colonic CD with with Simple Endoscopic Score for Crohn Disease =4 and ulcer score =1 in at least one segment 4) Fecal calprotectin =250 µg/g or C-reactive protein=0.5 mg/dL 5) Patients who have never been to exposed to biologic agent 6) Patients who are non-reponsive or intolerance to conventional therapy (corticosteroids, immunomodulators, or antibiotics, etc.) or contraindicated to conventional therapy 7) Patients who gave a voluentary informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have a history of hypersensitiviry to humanized proteins 2) Patients ever treated with corticosteroids within 8 weeks of screening date 3) a) Symptomatic intesintal stricture, b) Symptomatic anal stricture, c) Untreated intra-abdominal abscess, d) Untreated perianal abscess, e) Abdominal surgery within 6 months, f) Patients who are expected to require intestinal surgeries during study period - However, the following patients can be included: from baseline, 4 weeks or more after proper drainage of perianal abscess and from baseline, 8 weeks or more after proper drainage of intra-abdominal abscess 4) Active tuberculosis. However, the following patients can be included: Patients who were diagnosed with tuberculosis, but were properly treated with anti-tuberculosis therapy according to the standard guidelines and who were confirmed to be cured. 5) Latnet tuberculosis infection (LTBI): Patients confirmed as having latent tuberculosis through medical history, physical examination, chest X-ray, PPD skin test or interferon gamma release assay (IGRA) by a pulmonology specialist. However, patients with LTBI who finished proper treatment for LTBI for 4 weks and who are going to complete LTBI treatment. 6) HBsAg-positivity. Patients with negative HBsAg, but positive IgG anti-HBc should be tested for HBV DNA real time quantitative PCR. If HBV DNA real time quantitative PCR =10 IU/mL should be excluded. 7) Anti-HCV antibody-positivity 8) History of HIV infection of positivity for anti-HIV 9) Heart disease of NYHA Class III/IV 10) Active infection 11) Malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterinc cervis cancer) or history of colonic or small bowel dysplasia within 5 years 12) Pregnancy or lactating woman 13) Patients who are not applying proper contraceptive measures and patients who do not have a plan for proper contraceptive measures for at least 6 months after the last dose of infliximab (oral, parenteral, or implntable hormonal contraceptives, diaphragm, condom, intra-uterine device, or abstinence are accepted as proper contraceptive methods. 14) Patients who are decided to be not proper to be enrolled into the study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-inferiority of Arm 3 compared with Arm 2 in terms of deep remission rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-inferiority of Arm 3 compared with Arm 1 in terms of deep remission rate ;Corticoseroid-free endoscopic remission rate of each arm;Corticoseroid-free complete mucosal healing rate of each arm;Corticoseroid-free clincal response rate of each arm;Corticoseroid-free clincal remission rate of each arm;Corticoseroid-free clincal biochemical remission rate of each arm;Rate of anti-drug antiboty positivity;Safety evaluation (adverse event, vital sign, and laboratory results) | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Ja Youn
Asan Medical Center
Outcome results
None listed