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

UCB

Status and phase

Terminated

Phase 2

Conditions

Crohn's Disease

Treatments

Drug: Certolizumab Pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00899678

2014-004381-24 (EudraCT Number)

C87035

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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