Trial · NCT01421069
Registered outcomes80
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 80
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Malignancy: All Periods of Parent and Extension Study | 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. |
| Secondary | Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study | 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. |
| Secondary | Number of Participants With Serious Infections: All Periods of Parent and Extension Study | 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. |
| Secondary | Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study | 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. |
| Secondary | Number of Participants With Infections: All Periods of Parent and Extension Study | 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. |
| Secondary | Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study | 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. |
| Secondary | Number of Participants With Infections: Extension Study: Withdrawal Period | 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. |
| Secondary | Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study | 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. |
| Secondary | Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period | 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. |
| 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 | 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. |
| 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 | 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. |
| Secondary | Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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: | 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. |
| 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 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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