Crohn's DiseasePhase 2NURTURENCT00899678
The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents
A Phase 2 study testing Certolizumab Pegol in people with Crohn's Disease, run by UCB Celltech at 35 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Certolizumab Pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 35 sitesin 4 countries
- Study dates
- Apr 2009to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
United States24 sites
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Dallas, Texas
Study site
Hartford, Connecticut
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Milwaukee, Wisconsin
Study site
Morristown, New Jersey
Study site
Nashville, Tennessee
Study site
New Hyde Park, New York
Study site
Orange, California
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Rochester, Minnesota
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Shreveport, Louisiana
Canada6 sites
Study site
Edmonton, Alberta
Study site
Halifax, Nova Scotia
Study site
Hamilton, Ontario
Study site
London, Ontario
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Australia3 sites
Study site
Herston, Queensland
Study site
Parkville, Victoria
Study site
Randwick, New South Wales
New Zealand2 sites
Study site
Christchurch, Canterbury
Study site
Grafton, Auckland
About this study
Official 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)
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
- Being tested
- Certolizumab Pegol
- Keywords
- Certolizumab Pegol, Cimzia ®, Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab PegolDrug
Also called Cimzia, CDP870
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
Certolizumab PegolDrug
Also called Cimzia, CDP870
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Certolizumab Pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 62
Secondary outcomes (10)
Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62
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.
Measured: Week 62
Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)
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.
A negative value in change from Baseline indicates an improvement from Baseline to Week 62.
Measured: From Week 0 to Week 62
Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)
Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points.
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.
Measured: From Week 0 to Week 62
C-Reactive Protein (CRP) Levels at Week 62
The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD)
Measured: Week 62
Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)
The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD).
Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator.
Measured: From Week 0 to Week 62
Erythrocyte Sedimentation Rate (ESR) at Week 62
The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).
Measured: Week 62
Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)
The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).
Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator.
Measured: From Week 0 to Week 62
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.
Measured: From Week 0 to Week 62
Percentage of Subjects Who Initiated Steroid Tapering
Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose.
Measured: From Week 2 up to Week 8
Percentage of Subjects in Corticosteroid-free Remission at the End of the Study
Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available.
Measured: Last/Withdrawal Visit (up to Week 62)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: higher than projected discontinuation rate during Maintenance Phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Celltech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899678
- Sponsor's protocol ID
- C87035
- Other IDs
- 2014-004381-24, 2014
- Acronym
- NURTURE
- Status last verified
- Mar 2015
- First submitted
- 29 Apr 2009
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00899678
- Acronym / sponsor ID
- NURTURE / C87035
- Conditions
- Crohn's Disease
- Keywords
- Certolizumab Pegol, Cimzia ®, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: higher than projected discontinuation rate during Maintenance Phase
- Enrolment
- 99 participants (actual)
- Lead sponsor
- UCB CelltechIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 21 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance High-Dose | Active comparator | Drug: Certolizumab PegolMaintenance High-Dose group: 400 mg Certolizumab Pegol for subjects ≥ 40 kg or 200 mg Certolizumab Pegol for subjects 20 to < 40 kg |
| Maintenance Low-Dose | Active comparator | Drug: Certolizumab PegolMaintenance Low-Dose group: 200 mg Certolizumab Pegol for subjects ≥ 40 kg or 100 mg Certolizumab Pegol for subjects 20 to < 40 kg |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab PegolAlso: Cimzia, CDP870400 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 | Drug | Maintenance High-Dose |
| Certolizumab PegolAlso: Cimzia, CDP870200 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 | Drug | Maintenance Low-Dose |
Primary outcome
Percentage of Subjects in Clinical Remission at Week 62
Time frame: 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.
10 secondary outcomes
Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62
Time frame: Week 62
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 Achieving Clinical Response From Week 0 to the End of the Study (Week 62)
Time frame: From Week 0 to Week 62
C-Reactive Protein (CRP) Levels at Week 62
Time frame: 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
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
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
Percentage of Subjects Who Initiated Steroid Tapering
Time frame: From Week 2 up to Week 8
Percentage of Subjects in Corticosteroid-free Remission at the End of the Study
Time frame: Last/Withdrawal Visit (up to Week 62)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Certolizumab Pegol in people with Crohn's Disease, run by UCB Celltech at 35 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects in Clinical Remission at Week 62 (time frame: Week 62). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.