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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00962741




Registration number
NCT00962741
Ethics application status
Date submitted
13/08/2009
Date registered
20/08/2009
Date last updated
10/06/2014

Titles & IDs
Public title
Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Scientific title
A 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
Secondary ID [1] 0 0
B1801014
Secondary ID [2] 0 0
0881A1-3338
Universal Trial Number (UTN)
Trial acronym
CLIPPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Juvenile Idiopathic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etanercept

Experimental: 1 - Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg


Treatment: Drugs: Etanercept
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants With an ACR Pedi 30 Response
Timepoint [1] 0 0
Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [2] 0 0
Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population
Timepoint [2] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [3] 0 0
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Timepoint [3] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [4] 0 0
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Timepoint [4] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [5] 0 0
Percentage of Participants With an ACR Pedi 50 Response
Timepoint [5] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [6] 0 0
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Timepoint [6] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [7] 0 0
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Timepoint [7] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [8] 0 0
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Timepoint [8] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [9] 0 0
Percentage of Participants With an ACR Pedi 70 Response
Timepoint [9] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [10] 0 0
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Timepoint [10] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [11] 0 0
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Timepoint [11] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [12] 0 0
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Timepoint [12] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [13] 0 0
Percentage of Participants With an ACR Pedi 90 Response
Timepoint [13] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [14] 0 0
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Timepoint [14] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [15] 0 0
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Timepoint [15] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [16] 0 0
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Timepoint [16] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [17] 0 0
Percentage of Participants With an ACR Pedi 100 Response
Timepoint [17] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [18] 0 0
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Timepoint [18] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [19] 0 0
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Timepoint [19] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [20] 0 0
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Timepoint [20] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [21] 0 0
Physician's Global Assessment (PGA) of Disease Activity
Timepoint [21] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [22] 0 0
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
Timepoint [22] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [23] 0 0
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population
Timepoint [23] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [24] 0 0
Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population
Timepoint [24] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [25] 0 0
Patient/Parent Global Assessment
Timepoint [25] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [26] 0 0
Patient/Parent Global Assessment: eoJIA Sub-population
Timepoint [26] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [27] 0 0
Patient/Parent Global Assessment: ERA Sub-population
Timepoint [27] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [28] 0 0
Patient/Parent Global Assessment: PsA Sub-population
Timepoint [28] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [29] 0 0
Number of Active Joints
Timepoint [29] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [30] 0 0
Number of Active Joints: eoJIA Sub-population
Timepoint [30] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [31] 0 0
Number of Active Joints: ERA Sub-population
Timepoint [31] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [32] 0 0
Number of Active Joints: PsA Sub-population
Timepoint [32] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [33] 0 0
Number of Joints With Limitation of Motion
Timepoint [33] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [34] 0 0
Number of Joints With Limitation of Motion: eoJIA Sub-population
Timepoint [34] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [35] 0 0
Number of Joints With Limitation of Motion: ERA Sub-population
Timepoint [35] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [36] 0 0
Number of Joints With Limitation of Motion: PsA Sub-population
Timepoint [36] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [37] 0 0
C-reactive Protein (CRP)
Timepoint [37] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [38] 0 0
C-reactive Protein (CRP): eoJIA Sub-population
Timepoint [38] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [39] 0 0
C-reactive Protein (CRP): ERA Sub-population
Timepoint [39] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [40] 0 0
C-reactive Protein (CRP): PsA Sub-population
Timepoint [40] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [41] 0 0
Pain Assessment
Timepoint [41] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [42] 0 0
Pain Assessment: eoJIA Sub-population
Timepoint [42] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [43] 0 0
Pain Assessment: ERA Sub-population
Timepoint [43] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [44] 0 0
Pain Assessment: PsA Sub-population
Timepoint [44] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [45] 0 0
Duration of Morning Stiffness
Timepoint [45] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [46] 0 0
Duration of Morning Stiffness: eoJIA Sub-population
Timepoint [46] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [47] 0 0
Duration of Morning Stiffness: ERA Sub-population
Timepoint [47] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [48] 0 0
Duration of Morning Stiffness: PsA Sub-population
Timepoint [48] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [49] 0 0
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Timepoint [49] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [50] 0 0
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Timepoint [50] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [51] 0 0
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Timepoint [51] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [52] 0 0
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Timepoint [52] 0 0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [53] 0 0
Childhood Health Assessment Questionnaire (CHAQ) Score
Timepoint [53] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [54] 0 0
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Timepoint [54] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [55] 0 0
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Timepoint [55] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Secondary outcome [56] 0 0
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Timepoint [56] 0 0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Eligibility
Key inclusion criteria
- Male and female subjects with a diagnosis per International League of Associations for
Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis
(JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between
the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and
17 years.

- >= 2 active joints and the following for the relevant JIA subtype: extended
oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response
to a disease modifying antirheumatic drug (DMARD); or ERA with a history of
intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug
(NSAID) or a DMARD.
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated
arthritis per ILAR criteria.

- Other rheumatic diseases.

- Active uveitis within 6 months of the baseline visit.

- Any other significant health problem.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Westmead, Sydney
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Parkville, Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead, Sydney
Recruitment postcode(s) [2] 0 0
3052 - Parkville, Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Colombia
State/province [4] 0 0
Atlantico
Country [5] 0 0
Colombia
State/province [5] 0 0
Cundinamarca
Country [6] 0 0
Colombia
State/province [6] 0 0
Santander
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Brno
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha 2
Country [9] 0 0
France
State/province [9] 0 0
Le Kremlin Bicetre
Country [10] 0 0
France
State/province [10] 0 0
Paris Cedex 14
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Bremen
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Hannover
Country [16] 0 0
Germany
State/province [16] 0 0
St. Augustin
Country [17] 0 0
Hungary
State/province [17] 0 0
Budapest
Country [18] 0 0
Italy
State/province [18] 0 0
Chieti
Country [19] 0 0
Latvia
State/province [19] 0 0
Riga
Country [20] 0 0
Lithuania
State/province [20] 0 0
Vilnius
Country [21] 0 0
Mexico
State/province [21] 0 0
Mexico City
Country [22] 0 0
Netherlands
State/province [22] 0 0
Utrecht
Country [23] 0 0
Norway
State/province [23] 0 0
Oslo
Country [24] 0 0
Poland
State/province [24] 0 0
Bydgoszcz
Country [25] 0 0
Poland
State/province [25] 0 0
Krakow
Country [26] 0 0
Poland
State/province [26] 0 0
Warszawa
Country [27] 0 0
Poland
State/province [27] 0 0
Wroclaw
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Saint-Petersburg
Country [30] 0 0
Serbia
State/province [30] 0 0
Belgrade
Country [31] 0 0
Serbia
State/province [31] 0 0
Nis
Country [32] 0 0
Slovakia
State/province [32] 0 0
Kosice
Country [33] 0 0
Slovakia
State/province [33] 0 0
Piestany
Country [34] 0 0
Slovenia
State/province [34] 0 0
Ljubljana
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the effect of etanercept on the clinical benefit, safety, and
physical functioning (ability to function in daily life) in children and adolescent subjects
with 3 subtypes of childhood arthritis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00962741
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries