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
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 35 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01421069     History of Changes
Other Study ID Numbers: B1801023, 0881A1-3342
Study First Received: August 18, 2011
Last Updated: September 10, 2014
Health Authority: European Union: European Medicines Agency

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, Juvenile
Arthritis, Psoriatic
Autoimmune Diseases
Bone Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014