BridgeMD
Impact of early proactive therapeutic drug monitoring on the durability and efficacy of infliximab therapy in pediatric inflammatory bowel disease: a multicenter open-label randomized-control trial
EU CTIS ID: 2024-517759-11-00
What this study is testing
To evaluate the efficacy of E-pTDM compared to the standard IFX dosing schedule in improving IFX durability and efficacy during the first year of treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Anti-TNF naïve children and adolescents, 6-17 years, with a diagnosis of IBD confirmed by a prior endoscopic biopsy that is consistent with the diagnosis
- Indication to start anti-TNF therapy in accordance with current pediatric guidelines for the treatment of pediatric IBD,
- Active inflammation supported by CRP > 5mg/L and /or FC > 150 μg/g before the 1st IFX dose
You likely can't join if
- Patients who are not able or willing to sign informed consent
- Pregnancy or lactation (se paragraph 4.4 Pregnancy testing and contraception)
- Current cancer
- Stenosing or penetrating disease requiring surgery, abdominal abscess, symptomatic stricture,
- Abdominal surgery within the previous 6 months,
- Acute severe UC attack defined by a PUCAI score ³ 65,
See the full eligibility criteria
- Anti-TNF naïve children and adolescents, 6-17 years, with a diagnosis of IBD confirmed by a prior endoscopic biopsy that is consistent with the diagnosis
- Indication to start anti-TNF therapy in accordance with current pediatric guidelines for the treatment of pediatric IBD,
- Active inflammation supported by CRP > 5mg/L and /or FC > 150 μg/g before the 1st IFX dose
- Patients who are not able or willing to sign informed consent
- Pregnancy or lactation (se paragraph 4.4 Pregnancy testing and contraception)
- Current cancer
- Stenosing or penetrating disease requiring surgery, abdominal abscess, symptomatic stricture,
- Abdominal surgery within the previous 6 months,
- Acute severe UC attack defined by a PUCAI score ³ 65,
- Infective contraindication to IFX treatment including positive tuberculin skin test or Quantiferon-TB test, recent opportunistic infection, infection with hepatitis B (HBV), C (HCV), human immunodeficiency virus (HIV),
- Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients,
- Moderate or severe heart failure (NYHA class III/IV),
- Previous exposure to anti-TNF;
- Exposure to concomitant prohibited medications including other biologics (including but not limited to ustekinumab, vedolizumab, abatacept, anakinra..), thalidomide, investigational drugs
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.