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

This study has been terminated.
(higher than projected discontinuation rate during Maintenance Phase)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Celltech )
ClinicalTrials.gov Identifier:
NCT00899678
First received: April 29, 2009
Last updated: September 18, 2013
Last verified: September 2013
  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:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Percentage of Subjects in Clinical Remission at Week 62 [ Time Frame: Week 62 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62 [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
    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.

  • Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62) [ Time Frame: From Week 0 to Week 62 ] [ Designated as safety issue: No ]

    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.

    A negative value in change from Baseline indicates an improvement from Baseline to Week 62.


  • Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62) [ Time Frame: From Week 0 to Week 62 ] [ Designated as safety issue: No ]

    Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points.

    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.


  • C-Reactive Protein (CRP) Levels at Week 62 [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
    The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD)

  • Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62) [ Time Frame: From Week 0 to Week 62 ] [ Designated as safety issue: No ]

    The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD).

    Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator.


  • Erythrocyte Sedimentation Rate (ESR) at Week 62 [ Time Frame: Week 62 ] [ Designated as safety issue: No ]
    The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).

  • Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62) [ Time Frame: From Week 0 to Week 62 ] [ Designated as safety issue: No ]

    The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).

    Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator.


  • Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) [ Time Frame: From Week 0 to Week 62 ] [ Designated as safety issue: No ]
    The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.

  • Percentage of Subjects Who Initiated Steroid Tapering [ Time Frame: From Week 2 up to Week 8 ] [ Designated as safety issue: No ]
    Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose.

  • Percentage of Subjects in Corticosteroid-free Remission at the End of the Study [ Time Frame: Last/Withdrawal Visit (up to Week 62) ] [ Designated as safety issue: No ]
    Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available.


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: 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
Drug: Certolizumab Pegol

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

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

Other Names:
  • Cimzia
  • CDP870
Active Comparator: 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
Drug: Certolizumab Pegol

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

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

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 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
  • Subjects with any prior exposure to natalizumab
  • Subjects who have received mycophenolate or thalidomide within 4 weeks prior to Screening
  • Subjects who have received cyclosporin or tacrolimus within 6 months prior to Screening
  • Subjects who have received parenteral corticosteroids within 2 weeks prior to Screening
  • Subjects who have received corticosteroids or corticotrophins for indications other than CD within 2 weeks of Screening
  • Subject has a current or recent history (within 6 months prior to Screening) of significant and severe renal, hepatic, hematological, gastrointestinal (other than CD), endocrine, pulmonary, cardiac, neurological, or cerebral disease including blood dyscrasia (eg, pancytopenia, aplastic anemia), demyelinating disease (eg, multiple sclerosis, myelitis, optic neuritis), or ischemic heart disease
  • Subjects with a current sign or symptom indicating recent or chronic infections (including herpes zoster)
  • Subject has negative test for Immunoglobulin G (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
  • Subject has a history of TB or a positive chest x-ray suggestive of TB
  • Subjects with known concurrent viral hepatitis or Acquired Immune Deficiency Syndrome (AIDS) or known Human Immunodeficiency Virus (HIV) infection
  • Subjects with concurrent malignancy or history of malignancy, excluding treated squamous cell carcinoma of the skin
  • Subject has concurrent bowel dysplasia or a history of bowel dysplasia in the 5 years prior to Screening
  • Subjects with a history lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoma at any time
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899678

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

Additional Information:
No publications provided

Responsible Party: UCB Pharma ( UCB Celltech )
ClinicalTrials.gov Identifier: NCT00899678     History of Changes
Other Study ID Numbers: C87035
Study First Received: April 29, 2009
Results First Received: June 28, 2013
Last Updated: September 18, 2013
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 Pharma:
Certolizumab Pegol
Cimzia ®
Crohn's Disease

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

ClinicalTrials.gov processed this record on October 29, 2014