Efficacy and safety of formulation switching between infliximab SC and IV in patients with Crohn's disease (CHAMELEON Study)
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007470
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-inferiority of Arm 3 compared with Arm 2 in terms of deep remission rate
- Secondary Outcome Measures
Name Time Method on-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)