Infliximab Top-down in Pediatric Crohn (ITSKids)
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|ClinicalTrials.gov Identifier: NCT01880307|
Recruitment Status : Terminated (Not enough study subjects)
First Posted : June 18, 2013
Last Update Posted : July 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Azathioprine Drug: Infliximab Drug: Prednisolon||Phase 4|
Objective: The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe pediatric Crohn's disease (CD) patients.
Sample size: We will include 100 (2 x 50) patients. With these numbers a difference of 60% and 85% (= 25) can be shown at a power of 80% (2-sided α 0.05; nQuery Advisor).
Study design: an international open-label randomised controlled trial Study population: Children (age 3-17 yrs) with new-onset, untreated, CD with moderate-to-severe disease activity Intervention: Patients will be randomised to either top-down IFX treatment or conventional step-up treatment.
Treatment arm 1: Top-down IFX treatment will consist of a total of 5 IFX infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks) combined with oral azathioprine (AZA) 2-3 mg/kg once daily. AZA therapy will continue after the last IFX infusion to maintain remission.
Treatment arm 2: Step-up treatment will consist of standard induction treatment by oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop. Prednisolone will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment.
Main study parameters/endpoints: Clinical remission at 52 weeks without need for additional IBD related therapy or surgery. Secondary endpoints include clinical response, remission and mucosal healing at week 10 and 52, growth and adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Infliximab Top-down Study in Kids With Crohn's Disease|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2014|
Infliximab and azathioprine; patients will receive 5 infliximab infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks). IFX will be discontinued after 5 IFX infusions. Patients will also receive oral azathioprine 2-3 mg/kg, once daily as maintenance treatment.
Other Name: Imuran
Other Name: Remicade
Active Comparator: Step-up
Prednisolon and azathioprine; Patients will receive induction treatment with oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, then tapering of prednisolone in 6 weeks until stop, and receive oral azathioprine 2-3 mg/kg, once daily as maintenance treatment.
Other Name: Imuran
- Clinical remission without need for additional CD related therapy or surgery [ Time Frame: 52 weeks ]Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (wPCDAI) score of less than 10 points
- Clinical response and remission rate [ Time Frame: 10 weeks ]Response is defined by a decrease in PCDAI score above 15 points compared to baseline. Remission is PCDAI<10
- Mucosal healing [ Time Frame: 10 and 52 weeks ]Assessed by endoscopy (SES-CD) and/or fecal calprotectin (<100microgram/gram)
- Growth [ Time Frame: 10 and 52 weeks ]Change in height and BMI Z-scores, bone age and pubertal development
- Therapy failure rates over time [ Time Frame: 52 weeks ]Therapy failure: primary non-response, loss of response according to wPCDAI and medication intolerance
- Cumulative therapy use [ Time Frame: 52 weeks ]
- Adverse events rates [ Time Frame: 52 weeks ]Adverse events includes therapy side effects, disease complications (fistulas, abscesses, strictures, surgery, extra-intestinal manifestations)
- Long-term yearly remission rates without need for additional CD related therapy or surgery [ Time Frame: 260 weeks ]
- Long-term yearly clinical remission, response and mucosal healing (calprotectin) rates [ Time Frame: 260 weeks ]
- Yearly number of flares [ Time Frame: 260 weeks ]
- Cumulative therapy use [ Time Frame: 260 weeks ]
- Adverse event rates [ Time Frame: 260 weeks ]
- Pharmacokinetic properties of infliximab [ Time Frame: 52 weeks ]
- Identification of predictive biomarkers of therapy response [ Time Frame: 52 weeks ]
- Correlation between clinical disease activity, fecal calprotectin and endoscopic disease severity [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880307
|Erasmus Medical Center|
|Rotterdam, Zuid-Holland, Netherlands, 3000 CA|
|Principal Investigator:||Lissy Ridder, de, MD, PhD||Erasmus Medical Center|