A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

• Conditions: Crohn's Disease; MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2011-003742-40-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-20
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit.
2. Subjects must have been diagnosed and treated for active Crohn’s disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology and have a PCDAI = 10 (PCDAI = 10 confirms that the subject is in clinical remission.).
3. All subjects must weigh =15 kg at the time of enrolment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who have had any previous intestinal resection proximal to and including the ascending colon
2. Subjects with evidence of severe active Crohn’s Disease and/or, structuring and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
11. Subjects who have been screened/or enrolled in this study previously within the last 30 days.
13. Subjects who have been dosed in this study previously.
14. Subjects taking 6-mercaptopurine or azathioprine should be on stable doses for 3 months prior to study start, and should plan on maintaining this stable dose throughout the course of the study.
Initiation of azathioprine or 6-MP less than 3 months prior to study start or during the treatment phase of the trial is prohibited.
15. Subjects taking 5 aminosalicylates should be on stable doses 2 weeks prior to study start and should plan on maintaining this stable dose throughout the course of the study. Initiation of 5 aminosalicylates less than 2 weeks prior to study start or during treatment phase of study is prohibited.
16. Subjects taking Methotrexate should be on stable doses 6 weeks prior to study start and should plan on maintaining this stable dose throughout the course of the study.
17. Subjects taking antibiotics for Crohn’s disease (e.g., ciprofloxan) should be on stable doses 2 weeks prior to study start. Initiation of antibiotics for Crohn’s disease less than 2 weeks prior to study start or during treatment phase of the study is prohibited.
18. Subjects taking erythromycin and other macrolide antibiotics within 7 days of enrollment.
19. Subjects taking Enteral Nutrition therapy for Crohn’s disease should be on stable regimen 2 weeks prior to study start and should plan on maintaining this regimen throughout the course of the study.
20. Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender. Note: Subjects from the induction protocol (D9422C00001) with abnormal morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that Entocort 6 mg is an appropriate therapy option

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to investigate the safety of Entocort™ EC (budesonide) in a paediatric mild to moderate Crohn’s disease population for maintenance of clinical remission;Secondary Objective: To characterize the disease activity in the trial population before and after treatment through the paediatric Crohn’s Disease Activity Index (PCDAI); Patient reported outcomes: Quality of Life with Entocort EC treatment based on a subject questionnaire (IMPACT 3);Primary end point(s): Safety measures such as adverse events, GCS-related side effects, HPA-axis measurement, laboratory test results and vital signs will be listed and summarized descriptively, with summaries including all subjects who received at least one dose of study treatment. Summaries will be produced by all patients at the 6 mg dose.;Timepoint(s) of evaluation of this end point: at the end of the 12-week treatment period