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

April 6, 2022 updated by: Pfizer

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Malignancy: All Periods of Parent and Extension Study
Time Frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study
Time Frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Number of Participants With Serious Infections: All Periods of Parent and Extension Study
Time Frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Serious infections were defined as any infections those were life threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalization.
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study
Time Frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Medically important infections were defined as an infection requiring parenteral (intravenous [IV], intramuscular [IM]) anti-infective agent(s) and/or hospitalization.
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Number of Participants With Infections: All Periods of Parent and Extension Study
Time Frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Number of participants who had infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study
Time Frame: Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)
Number of participants who had treatment emergent infections and injection site reactions as adverse events were reported. Treatment emergent infections were infections occurring in a participant who received study medication without regard to possibility of causal relationship to it. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)
Number of Participants With Infections: Extension Study: Withdrawal Period
Time Frame: Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)
Number of participants who had treatment emergent infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)
Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study
Time Frame: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period
Time Frame: Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)
Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study
Time Frame: Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)
Abnormality of laboratory parameters was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)
Change From Baseline of Parent Study in Z-Score at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
Growth parameters including weight, height and body-mass index (BMI) were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, greater than (>) 0 a greater mean, and less than (<0) a lesser mean than the standard.
Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 withdrawal period of extension study
Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard.
Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 withdrawal period of extension study
Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 re-treatment period of extension study
Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard.
Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 withdrawal period of extension study
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 withdrawal period of extension study
Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 re-treatment period of extension study
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 re-treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 of Extension Study: Active Treatment Period
Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
Time Frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period:
Time Frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
ACR50PR: >=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
Time Frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
ACR50PR: >=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
Time Frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
ACR50PR:>=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria:1)PGA of disease activity(DA),2)PtGA of arthritis pain,3) CHAQ 4)number(no.) of active joints5)no. of joints with limited range of motion 6)C-reactive protein.PGA of DA: 21-circle VAS ranging 0-10, with 0=&10=maximumDA,higher score=more severe disease.PGA:21-circle VAS ranging 0-10,0=very well,10=very poor,higher scores=worsening condition.CHAQ: assessment of functional disability,discomfort. Ability to perform activities:dressing,arising,eating,walking,hygiene,reach,grip, common activities distributed in total of 30 items. Ranging 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do.Highest score for each domain:score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered.Ranged 0=no difficulty to 3=extreme difficulty;higher scores indicated more functional disability and discomfort. Participants >18 years assessed using CHAQ.
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
Time Frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
Time Frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
Time Frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
Time Frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
PGA of disease activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants Years at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in C-reactive Protein at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in C-reactive Protein at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in C-reactive Protein at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 re-treatment period of extension study
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day = 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Percentage of Participants With Clinically Inactive Disease at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of less than or equal to (<=) 15 minutes.
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Percentage of Participants With Clinically Inactive Disease at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of <=15 minutes.
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Percentage of Participants With Clinically Inactive Disease at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of <=15 minutes.
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Time Frame: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Overall Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
Time Frame: Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Overall Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of Extension study
Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of Extension study
Change From Baseline (of Parent Study) in Overall Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Overall back pain assessed by participant's parent using a 100 mm VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
Time Frame: Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)
Time Frame: Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)
Time Frame: Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
Time Frame: Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored on a 3-point scale ranged from 0 to 2 (0=normal mobility, 2=severe reduction, where higher scores indicated more reduction). The total BASMI score range from 0 to 10, where higher scores indicated more reduction in spinal mobility.
Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Percentage Body Surface Area (BSA) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1% of BSA. Regions of the body were assigned specific number of palms with percentage (Head and neck= 10% [10 palms], upper extremities= 20% [20 palms], Trunk [axillae and groin]= 30% [30 palms], lower extremities [buttocks]= 40% [40 palms]). The total BSA affected was the summation of individual regions affected.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Change From Baseline (of Parent Study) in Physician's Global Assessment (PGA) of Psoriasis Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)
Time Frame: Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5, where 0= no psoriasis to 5= severe disease, where higher scores indicated more severity. 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
All Cause Mortality: All Periods of Extension Study
Time Frame: Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
The considered event was death due to any cause from baseline to the end of the study.
Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Number of Participants With Prior Non-study Medication: All Periods of Extension Study
Time Frame: Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Prior non-study medications were defined as any non-study medications taken before the first dose of investigational product taken at the start of the study. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs and oral non-steroidal anti-inflammatory medication.
Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Number of Participants With Concomitant Non-study Medication: All Periods of Extension Study
Time Frame: Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Concomitant non-study medications were defined as any non-study medications taken during the treatment period. These included anti-infective medications, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs.
Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Number of Participants With After Non-study Medication: All Periods of Extension Study
Time Frame: Extension study: Last dose of study medication up to 30 days (maximum up to 97 months)
After non-study medications referred to any non-study medications taken after the last dose of the investigational product. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory medication and non-steroidal anti-inflammatory medication.
Extension study: Last dose of study medication up to 30 days (maximum up to 97 months)
Exposure Time: Extension Study: Active Treatment Period
Time Frame: Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
The exposure time (in years) to etanercept was calculated for each participant using the following formula: (the last dose date minus the first dose date plus 1)/365.25. If the gap was less than 28 days between two etanercept treatment periods, the cumulative exposure included the gap. Else, the gap was excluded from the cumulative exposure. Exposure time in year was converted into weeks and reported here.
Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Percentage of Participants With Total Childhood Health Assessment Questionnaire (CHAQ) Score Improvement of >0.188 at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Number of Participants With Vital Signs Abnormalities: Extension Study: Active Treatment Period
Time Frame: Month 96 active treatment period of extension study
Vital signs assessment included temperature, pulse, systolic and diastolic blood pressure. Pulse rate was obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.
Month 96 active treatment period of extension study

Collaborators and Investigators

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Sponsor

Pfizer

Publications and helpful links

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General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2011

Primary Completion (ACTUAL)

February 4, 2021

Study Completion (ACTUAL)

February 4, 2021

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (ESTIMATE)

August 22, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1801023
  • 0881A1-3342 (OTHER: Alias Study Number)
  • 2010-023802-10 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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