Juvenile Idiopahtic Arthritis Clinical Trial
— CLIPPER2Official 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)
| Verified date | April 2022 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | February 4, 2021 |
| Est. primary completion date | February 4, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 30 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Children's Hospital | Parkville, Melbourne | Victoria |
| Australia | The Children's Hospital at Westmead | Westmead, Sydney | New South Wales |
| Belgium | Cliniques Universitaires Saint Luc | Brussels | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Colombia | Servimed S.A.S | Bucaramanga | Santander |
| Czechia | Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie | Brno | |
| Czechia | Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze | Praha 2 | |
| Czechia | Revmatologicky ustav | Praha 2 | |
| France | Hopital Cochin | Paris | |
| France | Hopital NECKER-Enfants Malades | Paris | |
| Germany | HELIOS Klinikum Berlin-Buch | Berlin | |
| Germany | Klinikum Bremen-Mitte | Bremen | |
| Germany | Schön Klinik Hamburg Eilbek | Hamburg | |
| Germany | Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie | Saint Augustin | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Italy | Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio" | Chieti Scalo | |
| Latvia | University Children Hospital | Riga | |
| Latvia | University Children Hospital Gailezers | Riga | |
| Lithuania | Children's Hospital at Vilnius University Hospital "Santaros klinikos" | Vilnius | |
| Mexico | CLIDITER S.A. de C.V. | Mexico | D.f. |
| Netherlands | Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis, Room number KC 03-063 | Utrecht | |
| Norway | Depart. of Rheumatology | Oslo | |
| Poland | Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego | Bydgoszcz | |
| Poland | Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, | Krakow | |
| Poland | Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Klinika i | Warszawa | |
| Poland | Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno - Reumatologiczny | Wroclaw | |
| Russian Federation | FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy | Moscow | |
| Russian Federation | SBEI HPE Saint Petersburg State Pediatric Medical University | Saint-Petersburg | |
| Serbia | Institute of Rheumatology | Belgrade | |
| Serbia | Children's Clinic of Internal Medicine | Nis | |
| Slovakia | Narodny ustav reumatickych chorob | Piestany | |
| Slovenia | University Medical Centre Ljubljana, University Children's Hospital | Ljubljana | |
| Spain | Hospital San Juan de Dios | Esplugues de Llobregat | Barcelona |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | |
| Spain | Hospital Universitari i Politecnic La Fe de Valencia | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Australia, Belgium, Colombia, Czechia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Slovenia, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Malignancy: All Periods of Parent and 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 | Number of Participants With Serious Adverse Events: All Periods of Parent and 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) | |
| Secondary | Number of Participants With Serious Infections: All Periods of Parent and 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) | |
| Secondary | Number of Participants With Medically Important Infections: All Periods of Parent and 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) | |
| Secondary | Number of Participants With Infections: All Periods of Parent and 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) | |
| Secondary | Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study | 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) | |
| Secondary | Number of Participants With Infections: Extension Study: Withdrawal Period | 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) | |
| Secondary | Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and 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) | |
| Secondary | Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period | 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) | |
| Secondary | 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 | 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) | |
| Secondary | 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 | 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 | |
| Secondary | Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period | 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 | |
| Secondary | Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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: | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | 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) | 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 | |
| Secondary | 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) | 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 | |
| Secondary | 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) | 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 | |
| Secondary | 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) | 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 | |
| Secondary | 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) | 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 | |
| Secondary | 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) | 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 | |
| Secondary | 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) | 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 | |
| Secondary | 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) | 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 | |
| Secondary | 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) | 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 | |
| Secondary | All Cause Mortality: All Periods of Extension Study | 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) | |
| Secondary | Number of Participants With Prior Non-study Medication: All Periods of Extension Study | 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) | |
| Secondary | Number of Participants With Concomitant Non-study Medication: All Periods of Extension Study | 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) | |
| Secondary | Number of Participants With After Non-study Medication: All Periods of Extension Study | 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) | |
| Secondary | Exposure Time: Extension Study: Active Treatment Period | 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) | |
| Secondary | 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 | 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 | |
| Secondary | Number of Participants With Vital Signs Abnormalities: Extension Study: Active Treatment Period | 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 |