Status:
RECRUITING
Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Seoul National University Hospital
Severance Hospital
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The goal of this prospective, multicenter, open-label, randomized controlled, non-inferiority trial is to test efficacy and safety of formulation switching between subcutaneous (SC) infliximab and int...
Detailed Description
Remsima (CT-P13) is the first biosimilar of infliximab and its intravenous (IV) formulation has been used for patients with active Crohn's disease (CD). Recently, subcutaneous (SC) formulation of Rem...
Eligibility Criteria
Inclusion
- 18 years or older
- Moderate to severe Crohn's disease (Crohn's disease activity index 220 to 450)
- Ileocolonic Crohn's disease (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
- Fecal calprotectin ≥250 µg/g or C-reactive protein≥0.5 mg/dL
- Patients who have never been to exposed to any biologic agent
- Patients who are non-responsive or intolerance to conventional therapy (corticosteroids, immunomodulators, or antibiotics, etc.) or contraindicated to conventional therapy
- Patients who gave a voluntary informed consent
Exclusion
- Patients who have a history of hypersensitivity to humanized proteins
- Patients ever treated with corticosteroids within 8 weeks of screening date
- a) Symptomatic intestinal 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
- 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.
- Latent tuberculosis infection (LTBI): Patients confirmed as having latent tuberculosis through medical history, physical examination, chest X-ray, PPD (Purified Protein Derivative) 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.
- HBsAg (Hepatitis B virus surface antigen)-positivity. Patients with negative HBsAg, but positive IgG anti-HBc (Immunoglobulin G anti-Hepatitis B core antibody) should be tested for HBV (hepatitis B virus) DNA real time quantitative PCR (polymerase chain reaction). If HBV DNA real time quantitative PCR ≥10 IU/mL should be excluded.
- Anti-HCV (hepatitis C virus) antibody-positivity
- History of HIV (human immunodeficiency virus) infection of positivity for anti-HIV
- Heart disease of NYHA (New York Heart Association) Class III/IV
- Active infection
- Malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) or history of colonic or small bowel dysplasia within 5 years
- Pregnancy or lactating woman
- 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 implantable hormonal contraceptives, diaphragm, condom, intra-uterine device, or abstinence are accepted as proper contraceptive methods.
- Patients who are decided to be not proper to be enrolled into the study by investigators.
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06064864
Start Date
October 9 2023
End Date
December 31 2026
Last Update
May 14 2024
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505