NCT06064864 Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD
| NCT ID | NCT06064864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asan Medical Center |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-09 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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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 intravenous (IV) infliximab in patients with moderately to severely active Crohn's disease (CD). The primary endpoint of this study is deep remission at week 54. The main questions this study aims to answer are: Question-1) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab (5mg/kg every 8 weeks) in terms of deep remission at week 54? Question-2) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab (10mg/kg every 8 weeks) in terms of deep remission at week 54?
Eligibility Criteria
Inclusion Criteria: 1. 18 years or older 2. Moderate to severe Crohn's disease (Crohn's disease activity index 220 to 450) 3. 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 4. Fecal calprotectin ≥250 µg/g or C-reactive protein≥0.5 mg/dL 5. Patients who have never been to exposed to any biologic agent 6. Patients who are non-responsive or intolerance to conventional therapy (corticosteroids, immunomodulators, or antibiotics, etc.) or contraindicated to conventional therapy 7. Patients who gave a voluntary informed consent Exclusion Criteria: 1. Patients who have a history of hypersensitivity to humanized proteins 2. Patients ever treated with corticosteroids within 8 weeks of screening date 3. a) Symptomatic intestinal stricture, b) Symptomatic anal stricture, c) Untreated intra-abdominal abscess, d) Untreated perianal abscess, e) A
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