Biomarkers of Anti-TNF Treatment in Inflammatory Bowel Disease (IBD)

Sponsor
Erasmus Medical Center
Study ID
NCT01971970
Status
Completed

Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — BIOLOGICAL
    Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.
  • Adalimumab — BIOLOGICAL
    ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2

Study Details

Anti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for refractory pediatric and adult Crohn's disease (CD) patients, and is used for the induction (primary response) and maintenance of remission. When effective, clinical and endoscopic remission is reached within weeks. However, primary non-response is observed in 20% of pediatric patients, and in 40% of adult CD patients, suggesting a more robust acute response to anti-TNF therapy in children as compared to adults.During maintenance treatment, 60 - 80% of patients have secondary loss of response, necessitating dose adjustments to maintain clinical response. Anti-TNF treatment is also increasingly used in ulcerative colitis (UC), and has been shown to induce remission in active disease. For UC, the comparison between the efficacy in children versus adults is more difficult to report as studies in children are scarce. Anti-TNF treatment is associated with rare but potentially fatal side effects, infusion reactions, and is an expensive treatment. To avoid overtreatment it is necessary to early identify non-responders to treatment, and therefore it is important to develop predictive biomarkers of treatment response.

Key Dates

Start date
Oct 31, 2013
Status verified
Nov 2021
Primary completion
Oct 30, 2016
Completion
Jan 30, 2017

Study Design

Enrollment
45 participants (actual)

Arms

  • Arm: Pediatric IBD patients
    Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab
  • Arm: Adult IBD patients
    Anti-TNF naive patients with either Crohn's disease or ulcerative colitis will be treated with either Infliximab or Adalimumab

Primary Outcome Measure

Pre-treatment Serum Level of Endogenous Anti-TNF in Relation to Primary Clinical Response or Non-response [ Time Frame: 8 weeks ]

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