BridgeMD
New treatment option for Crohn Disease
Official title TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
ClinicalTrials.gov ID: NCT06051253
What this study is testing
What is TDM-based infliximab intravenous therapy?
TDM-based infliximab intravenous therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn disease.
Also referred to as TDM-based infliximab (CT-P13, RemsimaTM) intravenous therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- 1. Age: 19-80 years
- people diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, and radiologic findings, etc.
- people naive to both biological drugs (anti-TNFs, anti-integrin, anti-IL12/23, etc.) and investigational new drugs
- people with at least one draining perianal fistula
- people not responding to two or more conventional treatments (antibiotics, drainage, immunosuppressants, etc.)
You likely can't join if
- In cases where written informed consents cannot be provided by the study people or the people' legally acceptable representative
- Subject with a probability of receiving bowel surgery within 12 weeks after baseline, decided by investigators
- people with temporary or permanent stoma
- people with short bowel syndrome
- people not eligible due to significant bowel strictures or intra-abdominal abscesses
- people who received bowel surgery within 6 months of baseline or people who were admitted due to complications associated with bowel strictures or...
See the full eligibility criteria
- 1. Age: 19-80 years
- people diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, and radiologic findings, etc.
- people naive to both biological drugs (anti-TNFs, anti-integrin, anti-IL12/23, etc.) and investigational new drugs
- people with at least one draining perianal fistula
- people not responding to two or more conventional treatments (antibiotics, drainage, immunosuppressants, etc.)
- Women with a childbearing potential: Those who agree to follow contraception during study drug administration and for at least 6 months from the last dosing of the study medication
- In cases where written informed consents cannot be provided by the study people or the people' legally acceptable representative
- Subject with a probability of receiving bowel surgery within 12 weeks after baseline, decided by investigators
- people with temporary or permanent stoma
- people with short bowel syndrome
- people not eligible due to significant bowel strictures or intra-abdominal abscesses
- people who received bowel surgery within 6 months of baseline or people who were admitted due to complications associated with bowel strictures or intra-abdominal abscesses within 3 months of baseline
- people with enterovaginal fistula, enterocutaneous fistula, or enteroenteric fistula
- people previously exposed to biologics (anti-TNFs, anti-integrin, anti-IL12/23, etc.) or investigational new drugs
- people with a history of hypersensitivity to monoclonal antibody
- people requiring corticosteroid therapy. However, if oral corticosteroid dose lower or equivalent to prednisolone 20 mg/day before baseline is given and tapering of oral corticoseroid from baseline is planned, that...
- people with active tuberculosis. However, if the subject has a history of tuberculosis, which was cured with standard anti-tuberculosis therapy according to the standard anti-tuberculosis treatment guidelines, that...
- people with latent tuberculosis: people determined to be positive for latent tuberculosis by the pulmonology specialist after history taking, physical examination, chest X-ray, and interferon gamma release assay during...
- people positive for HBsAg. In cases of HBsAg (-), but with IgG Anti-HBc (+), real time quantitative PCR for HBV DNA is required. If HBV DNA is 10 IU/mL or over, that subject should be excluded
- people positive for anti-HCV antibody
- people with a history of infection with HIV or subject positive for HIV Ag
- people positive for Clostridioides difficile toxin assay or Clostridioides difficile culture assay
- people with a heart disease of NYHA Class III/IV
- people with current or previous demyelinating disease
- Subject with a history of malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) within 5 years or with a history of dysplasia of colon or small bowel within 5 years.
- people with symptoms or signs of active infection or with a history of treatment for infection within 8 weeks
- people with a history of organ transplantation
- Pregnant or lactating women
- Non-Korean ethnicity according to a family tree
- people decided to be not eligible for the study by investigators
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.