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

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
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 2011
Estimated Primary Completion Date :	March 2021
Estimated Study Completion Date :	March 2021

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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  Show 35 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01421069 History of Changes
Other Study ID Numbers:	B1801023; 0881A1-3342 ( Other Identifier: Alias Study Number ); 2010-023802-10 ( EudraCT Number )
First Posted:	August 22, 2011
Last Update Posted:	January 25, 2018
Last Verified:	January 2018

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:

Arthritis; Arthritis, Psoriatic; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin 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