Switching between subcutaneous and intravenous infliximab for Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.