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    Summary
    EudraCT Number:2014-004381-24
    Sponsor's Protocol Code Number:C87035
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004381-24
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents
    A.3.2Name or abbreviated title of the trial where available
    NURTURE
    A.4.1Sponsor's protocol code numberC87035
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00899678
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Celltech
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB Celltech
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Biosciences GmbH
    B.5.2Functional name of contact pointCTRRD
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Str. 10
    B.5.3.2Town/ cityMonheim am Rhein
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number00492173481515
    B.5.5Fax number00492173481572
    B.5.6E-mailclinicaltrials@ucb.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cimzia
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCertolizumab Pegol /Cimzia
    D.3.2Product code CDP870
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCERTOLIZUMAB PEGOL
    D.3.9.1CAS number 428863-50-7
    D.3.9.3Other descriptive nameCertolizumab Pegol
    D.3.9.4EV Substance CodeSUB25423
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study was to assess the efficacy of certolizumab pegol (CZP) in children and adolescents with moderately to severely active Crohn’s disease (CD).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of Subjects in Clinical Remission at Week 62
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 62
    E.5.2Secondary end point(s)
    - Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62
    - Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)
    - Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)
    - C-Reactive Protein (CRP) Levels at Week 62
    - Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)
    - Erythrocyte Sedimentation Rate (ESR) at Week 62
    - Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)
    - Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
    - Percentage of Subjects Who Initiated Steroid Tapering
    - Percentage of Subjects in Corticosteroid-free Remission at the End of the Study
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Week 62
    - From Week 0 to Week 62
    - From Week 2 up to Week 8
    - Last/Withdrawal Visit (up to Week 62)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Australia
    Canada
    New Zealand
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who completed the study could participate in the open-Label study CR0012 if they satisfied eligibility criteria of CR0012.
    Subjects who discontinued the study were to be given a standard treatment for Crohn's Disease deemed appropriate by the investigator.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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