A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study)

UCB Celltech0 sites99 target enrollmentApril 2009

ConditionsCrohn's Disease

InterventionsCertolizumab Pegol

DrugsCertolizumab Pegol

Overview

Phase: Phase 2
Intervention: Certolizumab Pegol
Conditions: Crohn's Disease
Sponsor: UCB Celltech
Enrollment: 99
Primary Endpoint: Percentage of Subjects in Clinical Remission at Week 62
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with moderately to severely active Crohn's disease. The target enrollment is 160 subjects.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

July 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Celltech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects with active Crohn's Disease (CD) confirmed 3 months prior to Screening
•Subjects with a Pediatric Crohn's Disease Activity Index (PCDAI) score of \> 30 at Week 0
•Subjects between the ages of 6 and 17, inclusive, prior to baseline dosing
•Subjects must weigh \> 20 kg (44 lbs)
•Subjects must have normal Electrocardiogram (ECG) or no medically relevant abnormalities as assessed by the investigator
•Subjects must meet Tuberculosis (TB) screening criteria
•Subjects taking corticosteroids, antibiotics and analgesics must have stable dosing, as defined, for one week

Exclusion Criteria

•Subjects who score \> 5 on the perirectal disease item of the PCDAI at Baseline
•Subjects who have had an active enterocutaneous fistulae within 3 months prior to Baseline
•Subjects with non-enterocutaneous fistulae, signs or symptoms of bowel obstruction or short bowel syndrome
•Subjects with a functional colostomy or ileostomy
•Subjects who have had surgical bowel resection within 6 months prior to Baseline or who may be planning any resection while enrolled in the study
•Subjects with clinical suspicion of intraabdominal abscesses
•Subjects with a positive stool result for enteric pathogens and/or parasites
•Subject has received any investigational biological therapies (within or outside a clinical trial) within 12 weeks prior to Screening or has been dosed in any clinical trial using non biological therapies within 4 weeks prior to Screening
•Subjects who have lost response to another Tumor Necrosis Factor (TNF) agent
•Subjects may not use another TNF agent within 12 weeks of Screening Visit

Arms & Interventions

Maintenance High-Dose

Maintenance High-Dose group: 400 mg Certolizumab Pegol for subjects ≥ 40 kg or 200 mg Certolizumab Pegol for subjects 20 to \< 40 kg

Intervention: Certolizumab Pegol

Maintenance Low-Dose

Maintenance Low-Dose group: 200 mg Certolizumab Pegol for subjects ≥ 40 kg or 100 mg Certolizumab Pegol for subjects 20 to \< 40 kg

Intervention: Certolizumab Pegol

Outcomes

Primary Outcomes

Percentage of Subjects in Clinical Remission at Week 62

Time Frame: Week 62

Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.

Secondary Outcomes

Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62(Week 62)
Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
C-Reactive Protein (CRP) Levels at Week 62(Week 62)
Erythrocyte Sedimentation Rate (ESR) at Week 62(Week 62)
Percentage of Subjects in Corticosteroid-free Remission at the End of the Study(Last/Withdrawal Visit (up to Week 62))
Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)(From Week 0 to Week 62)
Percentage of Subjects Who Initiated Steroid Tapering(From Week 2 up to Week 8)