Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis - Full Text View

Purpose

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	Intervention	Phase
Juvenile Idiopahtic Arthritis	Drug: etanercept	Phase 3


Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis psoriatic arthritis

MedlinePlus related topics: Arthritis Psoriatic Arthritis

Drug Information available for: Etanercept

Genetic and Rare Diseases Information Center resources: Enthesitis-related Juvenile Idiopathic Arthritis Spondylarthropathy

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Occurrence of malignancy [ Time Frame: up to 8 years ]

Secondary Outcome Measures:

Occurrence of withdrawals from investigational product [ Time Frame: up to 8 years ]
Physician's Global Assessment of Disease Activity on a 21-circle visual analogue scale [ Time Frame: up to 8 years ]
Patient/Parent Global Assessment on a 21-circle VAS [ Time Frame: up to 8 years ]
C-reative protein [ Time Frame: up to 8 years ]
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 ]
ACR Pediatric 30, 50, 70, 90, and 100 [ Time Frame: up to 8 years ]
Individual components of the ACR Pediatric Assessments [ Time Frame: up to 8 years ]
Pain Assessment on a 21-circle VAS [ Time Frame: up to 8 years ]
Duration of morning stiffness in minutes [ Time Frame: up to 8 years ]
Clinically inactive disease defined as follows per Wallace Criteria [ Time Frame: up to 8 years ]
The Juvenile Arthritis Disease Activity Score (JADAS) [ Time Frame: up to 8 years ]
Overall Back Pain and Nocturnal Back Pain on a 100 mm VAS (ERA subjects only) [ Time Frame: up to 8 years ]
Bath Ankylosing Spondylitis Metrology Index [ Time Frame: up to 8 years ]
Body Surface Area (PsA subjects only) [ Time Frame: up to 8 years ]
Physician Global Assessment of Psoriasis (PsA subjects only) [ Time Frame: up to 8 years ]


Enrollment:	109
Actual Study Start Date:	October 2011
Estimated Study Completion Date:	March 2021
Estimated Primary Completion Date:	March 2021 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421069

Show 35 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


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 )
Study First Received:	August 18, 2011
Last Updated:	August 14, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017

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