Actively Recruiting
TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
Led by Asan Medical Center · Updated on 2024-05-14
86
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will compare the efficacy and safety of TDM (therapeutic drug monitoring)-based infliximab (CT-P13, RemsimaTM) intravenous therapy compared with the standard infliximab (RemsimaTM) intravenous therapy for patients with active perianal fistulzing Crohn's disease.
CONDITIONS
Official Title
TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 80 years
- Diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, or radiologic evidence
- No prior treatment with biological drugs or investigational new drugs
- Presence of at least one draining perianal fistula
- Not responding to two or more conventional treatments such as antibiotics, drainage, or immunosuppressants
- Women with childbearing potential agree to use contraception during treatment and for at least 6 months after last dose
You will not qualify if you...
- Unable to provide written informed consent
- Likely to need bowel surgery within 12 weeks after baseline
- Having a temporary or permanent stoma
- Diagnosis of short bowel syndrome
- Significant bowel strictures or intra-abdominal abscesses making participation unsuitable
- Bowel surgery within 6 months before baseline or hospital admission for related complications within 3 months
- Presence of enterovaginal, enterocutaneous, or enteroenteric fistulas
- Previous exposure to biologics or investigational new drugs
- History of hypersensitivity to monoclonal antibodies
- Requiring corticosteroid therapy above prednisolone 20 mg/day at baseline (with planned tapering allowed below this dose)
- Active tuberculosis (cured or treated latent TB allowed under conditions)
- Positive for hepatitis B surface antigen or hepatitis C antibody, or active hepatitis B infection
- History or current infection with HIV
- Positive test for Clostridioides difficile toxin or culture
- Heart disease classified as NYHA Class III or IV
- Current or past demyelinating disease
- History of malignancy within 5 years (excluding certain skin cancers and cervical cancer) or dysplasia in colon or small bowel within 5 years
- Active infection symptoms or treatment within 8 weeks prior to baseline
- History of organ transplantation
- Pregnant or breastfeeding women
- Non-Korean ethnicity based on family tree
- Investigator decision of ineligibility for the study
AI-Screening
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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
E
Eun Ja Youn, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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