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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01421069
First received: August 18, 2011
Last updated: September 10, 2014
Last verified: September 2014

August 18, 2011
September 10, 2014
October 2011
January 2021   (final data collection date for primary outcome measure)
Occurrence of malignancy [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01421069 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
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

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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Juvenile Idiopahtic Arthritis
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.

Experimental: 1
Intervention: Drug: etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2021
January 2021   (final data collection date for primary outcome measure)

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.

Both
2 Years to 30 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Australia,   Belgium,   Colombia,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain
 
NCT01421069
B1801023, 0881A1-3342
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

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