Inflammatory Bowel Diseases Clinical Trial
— EPICOfficial title:
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
The purpose of the study is to assess whether a proactive therapeutic drug monitoring strategy, introduced early during treatment, improves Infliximab (IFX) durability, efficacy and safety in children and young adults with inflammatory bowel disease. Patients with an indication to receive IFX, based on current clinical practice recommendations, will receive the drug either based on IFX concentrations determined before every IFX infusion, starting from the third infusion, or at standard dosing. Approximately 90 patients will be included in this research study. Patients enrolled will be in the study for approximately 12 months.
Status | Recruiting |
Enrollment | 86 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | Inclusion Criteria: 1. 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 2. Indication to start anti-TNF therapy in accordance with current pediatric guidelines for the treatment of pediatric IBD 3. Active inflammation supported by CRP > 5mg/L and /or FC > 150 µg/g before the 1st IFX dose Exclusion Criteria: 1. Consent withdrawal, 2. Stenosing or penetrating disease requiring surgery, abdominal abscess, symptomatic stricture, 3. Abdominal surgery within the previous 6 months, 4. Acute severe ulcerative colitis attack defined by a PUCAI score Ñ 65, 5. 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), 6. Previous exposure to anti-TNF; 7. Exposure to concomitant prohibited medications including other biologics (including but not limited to ustekinumab, vedolizumab, abatacept, anakinra..), thalidomide, investigational drugs 8. Pregnancy or lactation |
Country | Name | City | State |
---|---|---|---|
Italy | Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" | Trieste |
Lead Sponsor | Collaborator |
---|---|
IRCCS Burlo Garofolo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of IFX discontinuation or need for treatment intensification due to non-response or LOR during the first year of treatment. | Composite outcome. Treatment intensification is defined as adjunction of rescue therapies, including corticosteroids systemic or topical, azathioprine (AZA), methotrexate (MTX), 5-aminosalicylate (5-ASA) systemic or topical, or rescue IFX escalation or surgery; treatment response is defined as a decrease in Pediatric Crohn's Disease Activity Index (PCDAI) by 12.5 point or in Pediatric Ulcerative Colitis Activity Index (PUCAI) by 10 points with decrease in C reactive protein (CRP) by 50% after induction, evaluated between 12-14 weeks; loss of response (LOR) is defined as PCDAI >= 10 or PUCAI > 10 with CRP > 0.5mg/dl and/or fecal calprotectin (FC) >250 microg/g in a patient who previously responded to induction treatment. | 54 weeks | |
Secondary | Cumulative probability of IFX discontinuation | Time to IFX discontinuation | 54 weeks | |
Secondary | Cumulative probability of Loss of Response | Time to Loss of Response (LOR), with LOR defined as PCDAI >= 10 or PUCAI > 10 with CRP > 0.5 mg/dl and/or FC >250 microg/g in a patient who previously responded to induction treatment. | 54 weeks | |
Secondary | Frequency of subtherapeutic IFX concentrations | Subtherapeutic IFX concentration is defined as IFX concentration at trough < 5 microg/ml (or <10 microg/ml in perianal CD) during maintenance treatment. | 54 weeks | |
Secondary | Frequency of Anti-Infliximab Antibodies | Evaluation of Anti-Infliximab Antibodies | 54 weeks | |
Secondary | Frequency of infusion reactions | Infusion reactions are defined as reactions that develop during the course of the infusion or within 1-2h of its completion. | 54 weeks | |
Secondary | Frequency of endoscopic remission | Endoscopic remission is defined in patients with Crohn's Disease as a Simple Endoscopic score for Crohn's Disease (SES-CD score) less than or equal to (<=) 2 and in patients with Ulcerative Colitis as a Mayo sub-score <= 1 | 54 weeks | |
Secondary | Frequency of patients with treatment response at the end of induction between 12 and 14 weeks | Treatment response is defined as a decrease in PCDAI by 12.5 point or in PUCAI by 10 points with decrease in CRP by 50% compared to baseline | Week 14 | |
Secondary | Frequency of patients with clinical remission at 14 weeks | Clinical remission is defined as PCDAI <10 or PUCAI <10 | Week 14 | |
Secondary | Frequency of clinical and biochemical remission at week 14 | Clinical and Biochemical remission is defined as PCDAI <10 or PUCAI <10 with CRP < 0.5 mg/dl and FC < 250 microg/g | Week 14 |
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