Trial · NCT03000439
Outcomes65
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 65
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase | From randomization up to 248 weeks | Double blind full analysis set (DBFAS) consisted of all randomized participants who received at least one dose of investigational product in the DB phase. | Days | MEDIAN |
| SECONDARY | Probability of Occurrence of sJIA Disease Flare at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: Double-Blind Phase | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. | Percentage probability of occurrence | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Successful Corticosteroid Tapering: at the End of Open-label Phase Part 2 | From end of OL Part 1 to up to 24 weeks in OL Part 2 | Open-label part 2 (OLP2) analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Corticosteroid Dose of <= 0.2 mg/kg/Day or 10 mg/Day: at the End of Open-label Phase Part 2 | From end of OL Part 1 to up to 24 weeks in OL Part 2 | OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adapted JIA ACR 30/50/70/90/100 Response at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adapted JIA American College of Rheumatology (ACR) 30/50/70/90/100 Response at Part 1 Day 7, Weeks 2, 4, 8, 12, and 16: Open-Label Phase Part 1 | Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12, and 16 | OLPT1 analysis set included all participants enrolled into the OL part 1 phase and received at least 1 dose of investigational product in part 1. All participants reported as 'Number of participants analyzed' contributed data to table; but may not have evaluable data for every row. Here, Number analyzed participants evaluable for specified time points and used for calculating percentages. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adapted JIA ACR 30/50/70/90/100 Response at Part 2 Weeks 4, 8, 12, 16, 20 and 24: Open-label Phase Part 2 | Part 2 Weeks 4, 8, 12, 16, 20 and 24 | OLPT2 analysis set included all participants enrolled into the OL part 2 phase and received at least 1 dose of investigational product in part 1. All participants reported as 'Number of participants analyzed' contributed data to table; but may not have evaluable data for every row. Here, Number analyzed: participants evaluable for specified time points and used for calculating percentages. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1 | Part 1 Days 3, 7 and 14 | OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, Number analyzed signifies participants evaluable for the specified time points and used for calculating percentages. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With C-Reactive Protein (CRP) <= 10 mg/L at Baseline, Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1 | Baseline (last value collected prior to Day 1 of study treatment), Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16 | OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under Number of participants analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number analyzed signifies participants evaluable for the specified time points and used for calculating percentages. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With C-Reactive Protein (CRP) <= 10 mg/L at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-label Phase Part 2 | Part 2 Weeks 4, 8, 12, 16, 20, 24 | OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here Number analyzed signifies participants evaluable for specified time points and used for calculating percentages. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Absence of Fever Due to sJIA at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1 | Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12, 16 | OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here Number analyzed signifies participants evaluable for specified time points and used for calculating percentages. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Absence of Fever Due to sJIA at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Part 2 Weeks 4, 8, 12, 16, 20 and 24 | OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under 'Number of participants analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, Number analyzed signifies participants evaluable for specified time points and used for calculating percentages. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Absence of Fever Due to sJIA at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: Double Blind Phase | DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Time to First Adapted JIA ACR 30 Response: Open-label Phase Part 1 | From Day 1 up to 16 weeks | OLPT1 analysis set included all participants who were enrolled into the OP part 1 phase of the study and received at least one dose of investigational product in part 1. | Days | MEDIAN |
| SECONDARY | Change From Open Label Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) Erythrocyte Sedimentation Rate (ESR) at Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16 | OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under Number of participants analyzed contributed data to the table; however, may not have evaluable data for every row. Here Number analyzed signifies participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Change From Open-Label Baseline in JADAS-27 CRP at Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16 | OLPT1 analysis set included all participants who were enrolled into the OL part 1 phase of the study and received at least one dose of investigational product in part 1. All participants reported under Number of participants analyzed contributed data to the table; however, may not have evaluable data for every row. Here Number analyzed signifies participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24 | OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under Number of participants analyzed contributed data to the table; however, may not have evaluable data for every row. Here Number analyzed signifies number of participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2 | Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24 | OLPT2 analysis set included all participants who were enrolled into the OL part 2 phase of the study and received at least one dose of investigational product in part 2. All participants reported under Number of participants analyzed contributed data to the table; however, may not have evaluable data for every row. Here Number analyzed signifies participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Change From Double-Blind Baseline in JADAS-27 ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase | DB Baseline (at randomization on Day 1 in DB phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under Number of participants analyzed contributed data to the table; however, may not have evaluable data for every row. Here Number analyzed signifies number of participants evaluable for specified rows. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Double-Blind Baseline in JADAS-27 CRP at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase | DB Baseline (at randomization on Day 1 in DB phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase. All participants reported under Number of participants analyzed contributed data to the table; however, may not have evaluable data for every row. Here Number analyzed signifies number of participants evaluable for specified rows. | Units on a scale | LEAST_SQUARES_MEAN |
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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