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: April 11, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421069

  Hide Study Locations
Locations
Australia, New South Wales
The Children's Hospital Westmead
Westmead, Sydney, New South Wales, Australia, 2145
Australia, Victoria
Royal Children's Hospital
Parkville, Melbourne, Victoria, Australia, 3052
Belgium
Clinique Universitaires Saint Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Colombia
Servimed EU
Bucaramanga, Santander, Colombia
Czech Republic
Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie
Brno, Czech Republic, 625 00
Revmatologicky ustav
Praha 2, Czech Republic, 128 50
Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN, Ke Karlovu 2
Praha 2, Czech Republic, 121 00
France
Hopital NECKER-Enfants Malades
Paris, France, F-75015
Hopital Cochin
Paris Cedex 14, France, 75674
Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Klinikum Bremen-Mitte gGmbH
Bremen, Germany, 28177
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie
Hamburg, Germany, 22081
Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie
St. Augustin, Germany, 53757
Hungary
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary, 1094
Italy
Clinica Pediatrica - Centro di Ricerca Clinica
Chieti, Italy, 66013
Latvia
University Children Hospital Gailezers
Riga, Latvia, 1079
University Children Hospital
Riga, Latvia, LV1004
Lithuania
Children's Hospital at Vilnius University Hospital "Santariškių klinikos"
Vilnius, Lithuania, 08406
Mexico
CLIDITER S.A. de C.V.
Mexico City, Mexico, 06700
Netherlands
Universitair Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 EA
Norway
Depart. of Rheumatology
Oslo, Norway, 0027
Poland
Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego
Bydgoszcz, Poland, 85-667
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
Krakow, Poland, 31-503
Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Klinika i
Warszawa, Poland, 02-637
Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno
Wroclaw, Poland, 52-114
Russian Federation
Institution of Russian academy of medical sciences Scientific-Research Institute of Rheumatology
Moscow, Russian Federation, 115522
Saint-Petersburg State Pediatric Medical Academy of the Minzdravsotsrazvitiya of Russia
Saint-Petersburg, Russian Federation, 194100
Serbia
Institute of Rheumatology
Belgrade, Serbia, 11000
Children's Clinic of Internal Medicine
Nis, Serbia, 18000
Slovakia
Narodny ustav reumatickych chorob
Piestany, Slovakia, 921 12
Slovenia
University Medical Centre Ljubljana, University Children's Hospital
Ljubljana, Slovenia, 1000
Spain
Hospital San Juan de Dios
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Ramon Y Cajal
Madrid, Spain, 28034
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
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: April 11, 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, Psoriatic
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 14, 2014