Switching between subcutaneous and intravenous infliximab for Crohn's disease
Efficacy and Safety of Formulation Switching Between Subcutaneous Infliximab and Intravenous Infliximab in Patients With Crohn's Disease
This study is testing if switching between two forms of infliximab can help people with moderate to severe Crohn's disease achieve better long-term results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06064864 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of switching between subcutaneous (SC) infliximab and intravenous (IV) infliximab in patients with moderately to severely active Crohn's disease. The study will assess whether maintenance therapy with SC infliximab is non-inferior to IV infliximab in achieving deep remission at week 54. Patients will be randomly assigned to different treatment arms based on their response to initial therapy. The trial seeks to provide clinical evidence for optimal infliximab formulation selection based on therapeutic response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe Crohn's disease who have not previously been treated with biologic agents.
Not a fit: Patients with a history of hypersensitivity to humanized proteins or those who have been treated with corticosteroids within 8 weeks prior to screening may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and flexible treatment option for patients with Crohn's disease.
How similar studies have performed: While this approach is novel in the context of switching formulations of infliximab, other studies have shown success with similar biosimilar treatments in inflammatory bowel diseases.
Eligibility criteria
Show full inclusion / exclusion 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) 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. 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. 6. 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. 7. Anti-HCV (hepatitis C virus) antibody-positivity 8. History of HIV (human immunodeficiency virus) infection of positivity for anti-HIV 9. Heart disease of NYHA (New York Heart Association) Class III/IV 10. Active infection 11. 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 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 implantable 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.
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Byong Duk Ye, MD, PhD — Asan Medical Center
- Study coordinator: Byong Duk Ye, MD, PhD
- Email: bdye@amc.seoul.kr
- Phone: 82-2-3010-3181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.