TerminatedNCT00899678NURTUREUpdated Aug 7, 2018Results posted

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

A Phase 2 interventional study of Certolizumab Pegol and Certolizumab Pegol in Crohn's Disease, sponsored by UCB Celltech. Terminated at 35 sites in 4 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-08-07.

Sponsored by UCB Celltech · Phase 2, Interventional, and Treatment

Why this study was terminated

higher than projected discontinuation rate during Maintenance Phase

Phase: Phase 2
Study type: Interventional
Enrollment: 99
Allocation: Randomized
Ages: 6 Years to 17 Years
Sex: All

Study 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 studied

Crohn's Disease

Browse trials for

Crohn Disease 1,880

Keywords

Certolizumab Pegol
Cimzia ®
Crohn's Disease

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 99 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

UCB Celltech is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 99 participants (actual)

Study arms

Active comparator
Maintenance High-Dose
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
Active comparator
Maintenance Low-Dose
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

DrugCertolizumab Pegol
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
DrugCertolizumab Pegol
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
Also known as: Cimzia, CDP870

What researchers measure

Primary outcomes

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.
Time frame: Week 62

Secondary outcomes

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.
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)
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.
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)
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.
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Last/Withdrawal Visit (up to Week 62)

Results

Posted Nov 21, 2013

Participant flow

The Participant Flow refers to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.

Induction Period (Weeks 0 to 6)

Participant flow — Induction Period (Weeks 0 to 6)
Milestone	Induction Only	Maintenance Low-Dose	Maintenance High-Dose
Started	27	37	35
Completed	2	37	35
Not completed	25	0	0
Withdrew: Adverse event	6	0	0
Withdrew: Lack of efficacy	17	0	0
Withdrew: Protocol violation	1	0	0
Withdrew: Other reason	1	0	0

Maintenance Period (Weeks 8 to 62)

Participant flow — Maintenance Period (Weeks 8 to 62)
Milestone	Maintenance Low-Dose	Maintenance High-Dose
Started	37	35
Completed	12	7
Not completed	25	28
Withdrew: Adverse event	10	5
Withdrew: Lack of efficacy	11	18
Withdrew: Protocol violation	1	1
Withdrew: Withdrawal by subject	1	2
Withdrew: Other reason	2	2

Outcome measures

PrimaryPercentage 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.

Time frame:: Week 62
Reported as:: Number · percentage of participants

Percentage of Subjects in Clinical Remission at Week 62
percentage of participants	Maintenance Low-Dose	Maintenance High-Dose
Percentage of Subjects in Clinical Remission at Week 62	24.3 (10.5 to 38.1)	17.1 (4.7 to 29.6)

SecondaryAbsolute 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.

Time frame:: Week 62
Reported as:: Mean · Score on a scale

Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62
Score on a scale	Maintenance Low-Dose	Maintenance High-Dose
Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62	8.18 ± 6.900	7.14 ± 7.830

SecondaryChange 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
Reported as:: Mean · units on a scale

Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)
units on a scale	Maintenance Low-Dose	Maintenance High-Dose
Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)	-29.77 ± 8.097	-27.14 ± 5.669

SecondaryPercentage 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.

Time frame:: From Week 0 to Week 62
Reported as:: Number · percentage of participants

Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)
percentage of participants	Maintenance Low-Dose	Maintenance High-Dose
Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)	29.7 (15.0 to 44.5)	20.0 (6.7 to 33.3)

SecondaryC-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)

Time frame:: Week 62
Reported as:: Geometric mean · mg/L

C-Reactive Protein (CRP) Levels at Week 62
mg/L	Maintenance Low-Dose	Maintenance High-Dose
C-Reactive Protein (CRP) Levels at Week 62	7.2 (2.5 to 20.7)	5.8 (2.1 to 15.7)

SecondaryChange 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.

Time frame:: From Week 0 to Week 62
Reported as:: Geometric mean · ratio

Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)
ratio	Maintenance Low-Dose	Maintenance High-Dose
Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)	0.49 (0.17 to 1.41)	1.84 (0.27 to 12.71)

SecondaryErythrocyte Sedimentation Rate (ESR) at Week 62

The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).

Time frame:: Week 62
Reported as:: Geometric mean · mm/h

Erythrocyte Sedimentation Rate (ESR) at Week 62
mm/h	Maintenance Low-Dose	Maintenance High-Dose
Erythrocyte Sedimentation Rate (ESR) at Week 62	20.9 (11.8 to 37.2)	25.2 (12.3 to 51.7)

SecondaryChange 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.

Time frame:: From Week 0 to Week 62
Reported as:: Geometric mean · ratio

Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)
ratio	Maintenance Low-Dose	Maintenance High-Dose
Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)	0.57 (0.31 to 1.04)	1.08 (0.39 to 3.02)

SecondaryChange 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.

Time frame:: From Week 0 to Week 62
Reported as:: Number · participants

Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
participants	Maintenance Low-Dose	Maintenance High-Dose
Increase from Stage I to Stage II	2	0
Increase from Stage I to Stage III	1	1
Increase from Stage II to Stage III	0	1
Increase from Stage III to Stage IV	2	0
Increase from Stage IV to Stage V	0	1
Decrease from Stage IV to Stage III	1	1
Subjects remained in Stage I	0	1
Subjects remained in Stage III	0	2
Subjects remained in Stage IV	1	0
Subjects remained in Stage V	3	0

SecondaryPercentage 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.

Time frame:: From Week 2 up to Week 8
Reported as:: Number · percentage of subjects

Percentage of Subjects Who Initiated Steroid Tapering
percentage of subjects	Maintenance Low-Dose	Maintenance High-Dose
Percentage of Subjects Who Initiated Steroid Tapering	71.4 (52.1 to 90.8)	65.0 (44.1 to 85.9)

SecondaryPercentage 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.

Time frame:: Last/Withdrawal Visit (up to Week 62)
Reported as:: Number · percentage of paticipants

Percentage of Subjects in Corticosteroid-free Remission at the End of the Study
percentage of paticipants	Maintenance Low-Dose	Maintenance High-Dose
Percentage of Subjects in Corticosteroid-free Remission at the End of the Study	23.8 (5.6 to 42.0)	15.0 (0.0 to 30.6)

Adverse events

Collected over Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Induction Period	—	6/99 (6.1%)	59/99 (59.6%)
Maintenance Low-Dose	—	4/37 (10.8%)	28/37 (75.7%)
Maintenance High-Dose	—	4/35 (11.4%)	27/35 (77.1%)
Overall Study	—	14/99 (14.1%)	78/99 (78.8%)

Most frequent serious events

Showing 10 of 18

Most frequent serious events
Event	Induction Period	Maintenance Low-Dose	Maintenance High-Dose	Overall Study
Abdominal PainGastrointestinal disorders	0/99	0/37	1/35	1/99
HaematocheziaGastrointestinal disorders	1/99	0/37	1/35	2/99
GastroenteritisInfections and infestations	0/99	0/37	1/35	1/99
Viral infectionInfections and infestations	0/99	0/37	1/35	1/99
Weight decreasedInvestigations	0/99	0/37	1/35	1/99
Anal fistulaGastrointestinal disorders	0/99	1/37	0/35	1/99
DiarrhoeaGastrointestinal disorders	0/99	1/37	0/35	1/99
PyrexiaGeneral disorders	0/99	1/37	0/35	1/99
CandidiasisInfections and infestations	0/99	1/37	0/35	1/99
Oral herpesInfections and infestations	0/99	1/37	0/35	1/99

Most frequent other events

Showing 10 of 36

Most frequent other events
Event	Induction Period	Maintenance Low-Dose	Maintenance High-Dose	Overall Study
PyrexiaGeneral disorders	9/99	6/37	9/35	20/99
Injection site painGeneral disorders	22/99	4/37	6/35	22/99
Upper respiratory tract infectionInfections and infestations	0/99	8/37	2/35	10/99
Crohn's diseaseGastrointestinal disorders	0/99	5/37	7/35	12/99
VomitingGastrointestinal disorders	6/99	3/37	6/35	13/99
Abdominal pain upperGastrointestinal disorders	4/99	5/37	2/35	9/99
DiarrhoeaGastrointestinal disorders	7/99	3/37	3/35	12/99
ArthralgiaMusculoskeletal and connective tissue disorders	6/99	4/37	2/35	12/99
HeadacheNervous system disorders	9/99	4/37	3/35	12/99
Abdominal painGastrointestinal disorders	4/99	3/37	4/35	10/99

Baseline characteristics

The Baseline characteristics refer to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.

Age, Continuous
Age, Continuous(years)	Induction Only	Maintenance Low-Dose	Maintenance High-Dose	Total
Mean	13.8 ± 2.67	13.2 ± 2.41	13.4 ± 2.46	13.4 ± 2.48

Age, Customized
Age, Customized(participants)	Induction Only	Maintenance Low-Dose	Maintenance High-Dose	Total
6-11 years	6	9	8	23
12-17 years	21	28	27	76

Sex: Female, Male
Sex: Female, Male(Participants)	Induction Only	Maintenance Low-Dose	Maintenance High-Dose	Total
Female	10	10	21	41
Male	17	27	14	58

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Induction Only	Maintenance Low-Dose	Maintenance High-Dose	Total
American Indian / Alaskan Native	0	0	0	0
Asian	1	0	0	1
Black	3	3	8	14
Native Hawaiian or other Pacific islander	0	0	0	0
White	22	32	27	81
Other / Mixed	1	2	0	3

Weight
Weight(kilogram)	Induction Only	Maintenance Low-Dose	Maintenance High-Dose	Total
Mean	46.50 ± 12.565	45.67 ± 14.638	50.35 ± 18.569	47.55 ± 15.642

Height
Height(centimeter)	Induction Only	Maintenance Low-Dose	Maintenance High-Dose	Total
Mean	157.46 ± 13.841	155.32 ± 13.589	157.22 ± 13.320	156.57 ± 13.460

Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram per square meter)	Induction Only	Maintenance Low-Dose	Maintenance High-Dose	Total
Mean	18.39 ± 2.504	18.51 ± 3.531	19.79 ± 4.897	18.93 ± 3.869

Body Surface Area (BSA)
Body Surface Area (BSA)(square meter)	Induction Only	Maintenance Low-Dose	Maintenance High-Dose	Total
Mean	1.42 ± 0.250	1.39 ± 0.272	1.47 ± 0.319	1.43 ± 0.283

Study locations

35 sites

Phoenix, Arizona, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Hartford, Connecticut, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Morristown, New Jersey, United States
New Hyde Park, New York, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Randwick, New South Wales, Australia
Herston, Queensland, Australia
Parkville, Victoria, Australia
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Grafton, Auckland, New Zealand
Christchurch, Canterbury, New Zealand

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00899678
Lead sponsor: UCB Celltech
Responsible party: Sponsor
First posted: May 12, 2009
Start date: Apr 2009
Primary completion: Jul 2012
Completion: Jul 2012
Results posted: Nov 21, 2013
Last update: Aug 7, 2018

Study contacts

UCB Clinical Trial Call Center

study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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