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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00899678
• Date of registration: 29/04/2009
• Prospective Registration: No
• Primary sponsor: UCB Celltech
• Public title: The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents NURTURE
• Scientific 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)
• Date of first enrolment: April 2009
• Target sample size: 99
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00899678
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, New Zealand, United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Certolizumab Pegol

Primary Outcome(s)

Percentage of Subjects in Clinical Remission at Week 62 [Time Frame: Week 62]

Secondary Outcome(s)

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]

Percentage of Subjects in Corticosteroid-free Remission at the End of the Study [Time Frame: Last/Withdrawal Visit (up to Week 62)]

Percentage of Subjects Who Initiated Steroid Tapering [Time Frame: From Week 2 up to Week 8]

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]

Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62 [Time Frame: Week 62]

C-Reactive Protein (CRP) Levels at Week 62 [Time Frame: Week 62]

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]

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]

Erythrocyte Sedimentation Rate (ESR) at Week 62 [Time Frame: 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]

Secondary ID(s)

C87035

2014-004381-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/11/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00899678