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The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents (NURTURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00899678
First received: April 29, 2009
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
 Drug: certolizumab pegol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • The primary efficacy variable is proportion of subjects in clinical remission using PCDAI. Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. [ Time Frame: Week 62 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute PCDAI scores [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
  • Change from Week 0 in PCDAI scores [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving clinical response, defined as a decrease from Week 0 in PCDAI score of a ≥ 15 points and a total PCDAI score ≤ 30 points [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
  • Proportion of subjects in clinical remission. Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10 at Week 62 [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
  • Change from Week 0 in CRP levels [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
  • Change from Week 0 in ESR [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
  • Change from Week 0 in growth scores (Tanner stage assessing puberty) [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
  • Proportion of subjects in corticosteroid free remission [ Time Frame: Week 62 ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 400mg/200mg
High-Dose group 400mg for subjects ≥ 40kg or 200mg for subjects 20 to < 40kg
 Drug: certolizumab pegol

400mg administered subcutaneously at once every 4 weeks for subjects ≥ 40kg or 200mg for subjects 20 to < 40kg

*prior to this dosing regimen, subjects will undergo an induction of certolizumab pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400mg for subjects ≥ 40kg or 200mg for subjects 20 to < 40kg

Other Names:
  • Cimzia
  • CDP870
Active Comparator: 200mg/100mg
Low-Dose group 200mg for subjects ≥40kg or 100mg for subjects 20 to <40kg
 Drug: certolizumab pegol

200mg administered subcutaneously at once every 4 weeks for subjects ≥ 40kg or 200mg for subjects 20 to < 40kg

*prior to this dosing regimen, subjects will undergo an induction of certolizumab pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400mg for subjects ≥ 40kg or 200mg for subjects 20 to < 40kg

Other Names:
  • Cimzia
  • CDP870

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Subjects who have lost response to another TNF agent
  • Subjects may not use another TNF agent within 12 weeks of Screening Visit
  • Subjects with any prior exposure to Tysabri (natalizumab)
  • Subjects who have current or recent activity (6 months)associated with significant and severe renal , hepatic, hematological, multiple sclerosis, demyelinating disease
  • Subjects with current or recent history (within 6 months to screening) of severe renal, hepatic, hematological, gastrointestinal (other than CD), endocrine, pulmonary, cardiac, neurological, cerebral disease, demyelinating disease or ischemic heart disease
  • Subjects with a current sign or symptom indicating recent or chronic infections (including herpes zoster)
  • Subject has negative test for IgG against Varicella zoster (chicken pox)
  • Subjects who have not completed their primary vaccination series, or are planning to have a live vaccine administered during the study period or up to 3 months after last dose of study drug
  • Subjects with known concurrent viral hepatitis or AIDS or known HIV infection
  • Subjects with concurrent malignancy or history of malignancy, excluding treated squamous cell carcinoma
  • Subjects with a history Lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoma at any time
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899678

  Show 35 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00899678     History of Changes
Other Study ID Numbers: C87035
Study First Received: April 29, 2009
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Keywords provided by UCB, Inc.:
Certolizumab Pegol
Cimzia ®
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013