Actively Recruiting
Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD
Led by Asan Medical Center · Updated on 2024-05-14
100
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Moderate to severe Crohn's disease with a Crohn's disease activity index between 220 and 450
- Ileocolonic Crohn's disease with a Simple Endoscopic Score for Crohn Disease of 6 or higher, or ileal or colonic Crohn's disease with a score of 4 or higher and ulcer score of 1 or higher in at least one segment
- Fecal calprotectin level of 250 g/g or higher, or C-reactive protein level of 0.5 mg/dL or higher
- No prior exposure to any biologic agent
- Non-responsive or intolerant to conventional therapies such as corticosteroids, immunomodulators, or antibiotics, or contraindicated to these therapies
- Voluntary informed consent given
You will not qualify if you...
- History of hypersensitivity to humanized proteins
- Use of corticosteroids within 8 weeks before screening
- Symptomatic intestinal or anal stricture, untreated intra-abdominal or perianal abscess, abdominal surgery within 6 months, or expected need for intestinal surgery during the study period
- Active tuberculosis, unless properly treated and confirmed cured
- Latent tuberculosis infection unless proper treatment has been completed or is ongoing
- Positive for Hepatitis B virus surface antigen, or positive IgG anti-Hepatitis B core antibody with high viral load
- Positive for hepatitis C virus antibody
- History of HIV infection or positive anti-HIV test
- Severe heart disease classified as NYHA Class III or IV
- Any active infection
- Malignancy (except certain skin cancers and uterine cervix cancer) or history of colonic or small bowel dysplasia within the past 5 years
- Pregnancy or breastfeeding
- Not using or planning to use proper contraceptive methods for at least 6 months after last infliximab dose
- Deemed unsuitable for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
B
Byong Duk Ye, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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