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

NCT ID: NCT00899678

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-07-31

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Certolizumab Pegol

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Certolizumab Pegol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Cimzia; CDP870; Cimzia; CDP870

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
• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Celltech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Phoenix, Arizona, United States

Los Angeles, California, United States

Orange, California, United States

San Francisco, California, United States

Aurora, Colorado, United States

Hartford, Connecticut, United States

Orlando, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Lexington, Kentucky, United States

Shreveport, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Rochester, Minnesota, United States

Morristown, New Jersey, United States

New Hyde Park, New York, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Seattle, Washington, United States

Milwaukee, Wisconsin, United States

Randwick, New South Wales, Australia

Herston, Queensland, Australia

Parkville, Victoria, Australia

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Halifax, Nova Scotia, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Toronto, Ontario, Canada

Grafton, Auckland, New Zealand

Christchurch, Canterbury, New Zealand

Countries

United States; Australia; Canada; New Zealand

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2014-004381-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C87035

Identifier Type: -

Identifier Source: org_study_id