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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00962741