CLIPPER2: Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01421069

Collaborator

(none)

109

Enrollment

Locations

Arm

111.9

Actual Duration (Months)

3.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

N/A

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 :

Oct 10, 2011

Actual Primary Completion Date :

Feb 4, 2021

Actual Study Completion Date :

Feb 4, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Occurrence of malignancy [up to 8 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital at Westmead	Westmead, Sydney	New South Wales	Australia	2145
2	Royal Children's Hospital	Parkville, Melbourne	Victoria	Australia	3052
3	Cliniques Universitaires Saint Luc	Brussels		Belgium	1200
4	Universitair Ziekenhuis Gent	Gent		Belgium	9000
5	Servimed S.A.S	Bucaramanga	Santander	Colombia	680003
6	Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie	Brno		Czechia	61300
7	Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze	Praha 2		Czechia	121 00
8	Revmatologicky ustav	Praha 2		Czechia	128 50
9	Hopital Cochin	Paris		France	75014
10	Hopital NECKER-Enfants Malades	Paris		France	75015
11	HELIOS Klinikum Berlin-Buch	Berlin		Germany	13125
12	Klinikum Bremen-Mitte	Bremen		Germany	28177
13	Hamburger Zentrum fuer Kinder- und Jugendrheumatologie	Hamburg		Germany	22081
14	Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie	Saint Augustin		Germany	53757
15	Semmelweis Egyetem	Budapest		Hungary	1094
16	Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio"	Chieti Scalo		Italy	66013
17	University Children Hospital Gailezers	Riga		Latvia	1079
18	University Children Hospital	Riga		Latvia	LV1004
19	Children's Hospital at Vilnius University Hospital "Santaros klinikos"	Vilnius		Lithuania	08406
20	CLIDITER S.A. de C.V.	Mexico	D.f.	Mexico	06700
21	Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis, Room number KC 03-063	Utrecht		Netherlands	3584 EA
22	Depart. of Rheumatology	Oslo		Norway	0027
23	Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego	Bydgoszcz		Poland	85-667
24	Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,	Krakow		Poland	31-503
25	Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Klinika i	Warszawa		Poland	02-637
26	Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno - Reumatologiczny	Wroclaw		Poland	52-114
27	FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy	Moscow		Russian Federation	115522
28	SBEI HPE Saint Petersburg State Pediatric Medical University	Saint-Petersburg		Russian Federation	194100
29	Institute of Rheumatology	Belgrade		Serbia	11000
30	Children's Clinic of Internal Medicine	Nis		Serbia	18000
31	Narodny ustav reumatickych chorob	Piestany		Slovakia	921 12
32	University Medical Centre Ljubljana, University Children's Hospital	Ljubljana		Slovenia	1000
33	Hospital San Juan de Dios	Esplugues de Llobregat	Barcelona	Spain	08950
34	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
35	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain	46026