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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01421069

First received: August 18, 2011

Last updated: June 10, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 18, 2011

Last Updated Date

June 10, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

January 2021 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Occurrence of malignancy [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01421069 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Occurrence of withdrawals from investigational product [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Physician's Global Assessment of Disease Activity on a 21-circle visual analogue scale [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Patient/Parent Global Assessment on a 21-circle VAS [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
C-reative protein [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
ACR Pediatric 30, 50, 70, 90, and 100 [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Individual components of the ACR Pediatric Assessments [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Pain Assessment on a 21-circle VAS [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Duration of morning stiffness in minutes [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Clinically inactive disease defined as follows per Wallace Criteria [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
The Juvenile Arthritis Disease Activity Score (JADAS) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Overall Back Pain and Nocturnal Back Pain on a 100 mm VAS (ERA subjects only) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Bath Ankylosing Spondylitis Metrology Index [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Body Surface Area (PsA subjects only) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Physician Global Assessment of Psoriasis (PsA subjects only) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Occurrence of withdrawals from investigational product [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Physician's Global Assessment of Disease Activity on a 21-circle visual analogue scale [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Patient/Parent Global Assessment on a 21-circle VAS [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
C-reative protein [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Juvenile Idiopahtic Arthritis

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: 1

Intervention: Drug: etanercept

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

January 2021

Estimated Primary Completion Date

January 2021 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

2 Years to 30 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Belgium, Colombia, Czech Republic, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Slovenia, Spain

Administrative Information

NCT Number ^ICMJE

NCT01421069

Other Study ID Numbers ^ICMJE

B1801023, 0881A1-3342

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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