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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421069
Recruitment Status : Active, not recruiting
First Posted : August 22, 2011
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Juvenile Idiopahtic Arthritis Drug: etanercept Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
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)
Actual Study Start Date : October 2011
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Occurrence of malignancy [ Time Frame: up to 8 years ]

Secondary Outcome Measures :
  1. Occurrence of withdrawals from investigational product [ Time Frame: up to 8 years ]
  2. Physician's Global Assessment of Disease Activity on a 21-circle visual analogue scale [ Time Frame: up to 8 years ]
  3. Patient/Parent Global Assessment on a 21-circle VAS [ Time Frame: up to 8 years ]
  4. C-reative protein [ Time Frame: up to 8 years ]
  5. 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 ]
  6. ACR Pediatric 30, 50, 70, 90, and 100 [ Time Frame: up to 8 years ]
  7. Individual components of the ACR Pediatric Assessments [ Time Frame: up to 8 years ]
  8. Pain Assessment on a 21-circle VAS [ Time Frame: up to 8 years ]
  9. Duration of morning stiffness in minutes [ Time Frame: up to 8 years ]
  10. Clinically inactive disease defined as follows per Wallace Criteria [ Time Frame: up to 8 years ]
  11. The Juvenile Arthritis Disease Activity Score (JADAS) [ Time Frame: up to 8 years ]
  12. Overall Back Pain and Nocturnal Back Pain on a 100 mm VAS (ERA subjects only) [ Time Frame: up to 8 years ]
  13. Bath Ankylosing Spondylitis Metrology Index [ Time Frame: up to 8 years ]
  14. Body Surface Area (PsA subjects only) [ Time Frame: up to 8 years ]
  15. Physician Global Assessment of Psoriasis (PsA subjects only) [ Time Frame: up to 8 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421069

  Hide Study Locations
Australia, New South Wales
The Children's Hospital at Westmead
Westmead, Sydney, New South Wales, Australia, 2145
Australia, Victoria
Royal Children's Hospital
Parkville, Melbourne, Victoria, Australia, 3052
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Servimed S.A.S
Bucaramanga, Santander, Colombia, 680003
Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie
Brno, Czechia, 61300
Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze
Praha 2, Czechia, 121 00
Revmatologicky ustav
Praha 2, Czechia, 128 50
Hopital Cochin
Paris, France, 75014
Hopital NECKER-Enfants Malades
Paris, France, 75015
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Klinikum Bremen-Mitte gGmbH
Bremen, Germany, 28205
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie
Hamburg, Germany, 22081
Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie
Saint Augustin, Germany, 53757
Semmelweis Egyetem
Budapest, Hungary, 1094
Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio"
Chieti Scalo, Italy, 66013
University Children Hospital Gailezers
Riga, Latvia, 1079
University Children Hospital
Riga, Latvia, LV1004
Children's Hospital at Vilnius University Hospital "Santariškių klinikos"
Vilnius, Lithuania, 08406
Mexico, D.f., Mexico, 06700
Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis
Utrecht, Netherlands, 3584 EA
Depart. of Rheumatology
Oslo, Norway, 0027
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 - Reumatologiczny
Wroclaw, Poland, 52-114
Russian Federation
FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy
Moscow, Russian Federation, 115522
SBEI HPE Saint Petersburg State Pediatric Medical University
Saint-Petersburg, Russian Federation, 194100
Institute of Rheumatology
Belgrade, Serbia, 11000
Children's Clinic of Internal Medicine
Nis, Serbia, 18000
Narodny ustav reumatickych chorob
Piestany, Slovakia, 921 12
University Medical Centre Ljubljana, University Children's Hospital
Ljubljana, Slovenia, 1000
Hospital San Juan de Dios
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01421069     History of Changes
Other Study ID Numbers: B1801023
0881A1-3342 ( Other Identifier: Alias Study Number )
2010-023802-10 ( EudraCT Number )
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors