The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents - Full Text View

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Certolizumab pegol

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

Hide Study Locations

Locations

United States, Arizona

Phoenix, Arizona, United States
United States, California

Los Angeles, California, United States

Orange, California, United States

San Francisco, California, United States
United States, Colorado

Aurora, Colorado, United States
United States, Connecticut

Hartford, Connecticut, United States
United States, Florida

Orlando, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Illinois

Chicago, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Kentucky

Lexington, Kentucky, United States
United States, Louisiana

Shreveport, Louisiana, United States
United States, Maryland

Baltimore, Maryland, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, Minnesota

Rochester, Minnesota, United States
United States, New Jersey

Morristown, New Jersey, United States
United States, New York

New Hyde Park, New York, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States
United States, Tennessee

Nashville, Tennessee, United States
United States, Texas

Dallas, Texas, United States

Houston, Texas, United States
United States, Washington

Seattle, Washington, United States
United States, Wisconsin

Milwaukee, Wisconsin, United States
Australia, New South Wales

Randwick, New South Wales, Australia
Australia, Queensland

Herston, Queensland, Australia
Australia, Victoria

Parkville, Victoria, Australia
Canada, Alberta

Edmonton, Alberta, Canada
Canada, British Columbia

Vancouver, British Columbia, Canada
Canada, Nova Scotia

Halifax, Nova Scotia, Canada
Canada, Ontario

Hamilton, Ontario, Canada

London, Ontario, Canada

Toronto, Ontario, Canada
New Zealand

Grafton, Auckland, New Zealand

Christchurch, Canterbury, New Zealand

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 19, 2013

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