Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (CLIPPER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00962741
First received: August 13, 2009
Last updated: May 29, 2014
Last verified: May 2014
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Arthritis, Juvenile Idiopathic
Intervention: Drug: Etanercept

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Etanercept Etanercept was administered 0.8 milligram/kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.

Participant Flow:   Overall Study
    Etanercept  
STARTED     127  
COMPLETED     119  
NOT COMPLETED     8  
Failed to return                 3  
Lost to Follow-up                 2  
Withdrawal by Subject                 1  
Lack of Efficacy                 1  
drug ineffective+prohibited drug taken                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Etanercept Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.

Baseline Measures
    Etanercept  
Number of Participants  
[units: participants]
  127  
Age  
[units: Years]
Mean ± Standard Deviation
  11.70  ± 4.51  
Gender  
[units: Participants]
 
Female     72  
Male     55  



  Outcome Measures
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1.  Primary:   Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Percentage of Participants With an ACR Pedi 30 Response   [ Time Frame: Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

3.  Secondary:   Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

4.  Secondary:   Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

5.  Secondary:   Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

6.  Secondary:   Percentage of Participants With an ACR Pedi 50 Response   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

7.  Secondary:   Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

8.  Secondary:   Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

9.  Secondary:   Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

10.  Secondary:   Percentage of Participants With an ACR Pedi 70 Response   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

11.  Secondary:   Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

12.  Secondary:   Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

13.  Secondary:   Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

14.  Secondary:   Percentage of Participants With an ACR Pedi 90 Response   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

15.  Secondary:   Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

16.  Secondary:   Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

17.  Secondary:   Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

18.  Secondary:   Percentage of Participants With an ACR Pedi 100 Response   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

19.  Secondary:   Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

20.  Secondary:   Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

21.  Secondary:   Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

22.  Secondary:   Physician's Global Assessment (PGA) of Disease Activity   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

23.  Secondary:   Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

24.  Secondary:   Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

25.  Secondary:   Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

26.  Secondary:   Patient/Parent Global Assessment   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

27.  Secondary:   Patient/Parent Global Assessment: eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

28.  Secondary:   Patient/Parent Global Assessment: ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

29.  Secondary:   Patient/Parent Global Assessment: PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

30.  Secondary:   Number of Active Joints   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

31.  Secondary:   Number of Active Joints: eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

32.  Secondary:   Number of Active Joints: ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

33.  Secondary:   Number of Active Joints: PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

34.  Secondary:   Number of Joints With Limitation of Motion   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

35.  Secondary:   Number of Joints With Limitation of Motion: eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

36.  Secondary:   Number of Joints With Limitation of Motion: ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

37.  Secondary:   Number of Joints With Limitation of Motion: PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

38.  Secondary:   C-reactive Protein (CRP)   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

39.  Secondary:   C-reactive Protein (CRP): eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

40.  Secondary:   C-reactive Protein (CRP): ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

41.  Secondary:   C-reactive Protein (CRP): PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

42.  Secondary:   Pain Assessment   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

43.  Secondary:   Pain Assessment: eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

44.  Secondary:   Pain Assessment: ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

45.  Secondary:   Pain Assessment: PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

46.  Secondary:   Duration of Morning Stiffness   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

47.  Secondary:   Duration of Morning Stiffness: eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

48.  Secondary:   Duration of Morning Stiffness: ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

49.  Secondary:   Duration of Morning Stiffness: PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

50.  Secondary:   Percentage of Participants With Inactive Disease Per Wallace 2004 Definition   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

51.  Secondary:   Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

52.  Secondary:   Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

53.  Secondary:   Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

54.  Secondary:   Childhood Health Assessment Questionnaire (CHAQ) Score   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

55.  Secondary:   Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

56.  Secondary:   Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

57.  Secondary:   Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

58.  Other Pre-specified:   Tender Entheseal Assessment for ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

59.  Other Pre-specified:   Overall Back Pain Score for ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

60.  Other Pre-specified:   Nocturnal Back Pain Score for ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

61.  Other Pre-specified:   Modified Schober's Test for ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

62.  Other Pre-specified:   Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

63.  Other Pre-specified:   Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

64.  Other Pre-specified:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Week 12, Week 96 ]

65.  Other Pre-specified:   Number of Participants With Adverse Events (AEs): eoJIA Subpopulation   [ Time Frame: Week 12, Week 96 ]

66.  Other Pre-specified:   Number of Participants With Adverse Events (AEs): ERA Sub-population   [ Time Frame: Week 12, Week 96 ]

67.  Other Pre-specified:   Number of Participants With Adverse Events (AEs): PsA Sub-population   [ Time Frame: Week 12, Week 96 ]

68.  Other Pre-specified:   Tanner Assessment Score by Age Group   [ Time Frame: Baseline, Week 12, Week 48, Week 96 ]

69.  Other Pre-specified:   Tanner Assessment Score by Age Group for eoJIA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 96 ]

70.  Other Pre-specified:   Tanner Assessment Score by Age Group for ERA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 96 ]

71.  Other Pre-specified:   Tanner Assessment Score by Age Group for PsA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 96 ]

72.  Other Pre-specified:   Height z-Score by Age Group   [ Time Frame: Baseline, Week 12, Week 48, Week 72, Week 96 ]

73.  Other Pre-specified:   Height z-Score by Age Group for eoJIA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 72, Week 96 ]

74.  Other Pre-specified:   Height z-Score by Age Group for ERA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 72, Week 96 ]

75.  Other Pre-specified:   Height z-Score by Age Group for PsA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 72, Week 96 ]

76.  Other Pre-specified:   Weight z-Scores by Age Group   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

77.  Other Pre-specified:   Weight z-Scores by Age Group for eoJIA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

78.  Other Pre-specified:   Weight z-Scores by Age Group for ERA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

79.  Other Pre-specified:   Weight z-Scores by Age Group for PsA Sub-population   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]

80.  Other Pre-specified:   Body Mass Index (BMI) z-Score by Age Group   [ Time Frame: Baseline, Week 12, Week 48, Week 72, Week 96 ]

81.  Other Pre-specified:   Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 72, Week 96 ]

82.  Other Pre-specified:   Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 72, Week 96 ]

83.  Other Pre-specified:   Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population   [ Time Frame: Baseline, Week 12, Week 48, Week 72, Week 96 ]

84.  Other Pre-specified:   Number of Participants With Anti-etanercept Antibodies   [ Time Frame: Baseline up to Week 12, Week 48, Week 96 ]

85.  Other Pre-specified:   Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population   [ Time Frame: Baseline up to Week 12, Week 48, Week 96 ]

86.  Other Pre-specified:   Number of Participants With Anti-etanercept Antibodies: ERA Sub-population   [ Time Frame: Baseline up to Week 12, Week 48, Week 96 ]

87.  Other Pre-specified:   Number of Participants With Anti-etanercept Antibodies: PsA Sub-population   [ Time Frame: Baseline up to Week 12, Week 48, Week 96 ]

88.  Other Pre-specified:   Number of Participants With Neutralizing Anti-etanercept Antibodies   [ Time Frame: Baseline up to Week 12, Week 48, Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Results include data for Part 1 (up to Week 12) and Part 2 (up to week 96) of the study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00962741     History of Changes
Other Study ID Numbers: 0881A1-3338, B1801014
Study First Received: August 13, 2009
Results First Received: June 14, 2012
Last Updated: May 29, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Depart