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

NCT00899678 | Terminated Phase 2 Results DMC

• 2 other identifiers: C870352014-004381-24
• Study Type: interventional
• Target: 99
• Locations: 4 countries
• Sites: 35

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

Keywords

Certolizumab Pegol; Cimzia ®; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects in Clinical Remission at 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.

  Week 62

Secondary Outcomes (10)

• Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62

  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

• Percentage of Subjects Achieving Clinical Response 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

• Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)

  From Week 0 to Week 62

Study Arms (2)

Maintenance High-Dose

ACTIVE COMPARATOR

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

Maintenance Low-Dose

ACTIVE COMPARATOR

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

Interventions

Certolizumab Pegol 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

Also known as: Cimzia, CDP870

Maintenance High-Dose

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Celltech: lead

Study Sites (35)

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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Orange, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Hartford, Connecticut, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Rochester, Minnesota, United States

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Morristown, New Jersey, United States

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New Hyde Park, New York, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Randwick, New South Wales, Australia

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Herston, Queensland, Australia

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Parkville, Victoria, Australia

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Grafton, Auckland, New Zealand

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Christchurch, Canterbury, New Zealand

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Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Crohn Disease

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: May 12, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 7, 2018
• Results First Posted: November 21, 2013

Record last verified: 2015-03

Locations

CA (6); US (24); AU (3); NZ (2)