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Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (CLIPPER2)

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ClinicalTrials.gov Identifier: NCT01421069
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).

Condition or disease Intervention/treatment Phase
Juvenile Idiopahtic Arthritis Drug: etanercept Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: N/A
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)
Actual Study Start Date : October 10, 2011
Actual Primary Completion Date : February 4, 2021
Actual Study Completion Date : February 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Etanercept

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: etanercept

Subjects aged <18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW).

Subjects aged greater than or equal to 18 years or >62 kg will receive etanercept SC at a dose of 50 mg QW.


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of malignancy [ Time Frame: up to 8 years ]

Secondary Outcome Measures :
  1. Occurrence of withdrawals from investigational product [ Time Frame: up to 8 years ]
  2. Physician's Global Assessment of Disease Activity on a 21-circle visual analogue scale [ Time Frame: up to 8 years ]
  3. Patient/Parent Global Assessment on a 21-circle VAS [ Time Frame: up to 8 years ]
  4. C-reative protein [ Time Frame: up to 8 years ]
  5. Childhood Health Assessment Questionnaire (CHAQ) for subjects less than 18 years of age; Health Assessment Questionnaire (HAQ) for subjects greater than or equal to 18 years of age. [ Time Frame: up to 8 years ]
  6. ACR Pediatric 30, 50, 70, 90, and 100 [ Time Frame: up to 8 years ]
  7. Individual components of the ACR Pediatric Assessments [ Time Frame: up to 8 years ]
  8. Pain Assessment on a 21-circle VAS [ Time Frame: up to 8 years ]
  9. Duration of morning stiffness in minutes [ Time Frame: up to 8 years ]
  10. Clinically inactive disease defined as follows per Wallace Criteria [ Time Frame: up to 8 years ]
  11. The Juvenile Arthritis Disease Activity Score (JADAS) [ Time Frame: up to 8 years ]
  12. Overall Back Pain and Nocturnal Back Pain on a 100 mm VAS (ERA subjects only) [ Time Frame: up to 8 years ]
  13. Bath Ankylosing Spondylitis Metrology Index [ Time Frame: up to 8 years ]
  14. Body Surface Area (PsA subjects only) [ Time Frame: up to 8 years ]
  15. Physician Global Assessment of Psoriasis (PsA subjects only) [ Time Frame: up to 8 years ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)

Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Exclusion criteria for subject planning to continue investigational product:

withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).

History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421069


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01421069    
Other Study ID Numbers: B1801023
0881A1-3342 ( Other Identifier: Alias Study Number )
2010-023802-10 ( EudraCT Number )
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
Use of etanercept to treat pediatric subjects with extended oligoarticular JIA
enthestitis related arthritis (ERA)
or psoriatic arthritis (PsA).
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors