Trial · NCT03000439
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
NCT03000439, Phase 3, Completed, Pfizer; results first posted 2025-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA. Trials, record NCT03000439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03000439
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
- NCT number
- NCT03000439
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Arthritis Juvenile Idiopathic
- Interventions
- In open-label phase: treatment with tofacitinib, In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
- First posted
- 2016-12-22
- Last updated
- 2025-06-03
- Other registries' IDs
- eudract:2017-002018-29
- Results first posted
- 2025-06-03
Source ClinicalTrials.gov
Registered outcomes65
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase | From randomization up to 248 weeks | Time to the disease flare=the number of days from randomization to flare in the DB phase and calculated as date of disease flare minus (-) date of randomization plus (+) 1. sJIA Flare=as at least one of the following criteria: Recurrence of fever \>38 degree Celsius (C)/100.4 degree Fahrenheit (F) on 2 or more consecutive days) was considered due to SJIA activity. Worsening of 30 percent (%) or more in three or more of the six variables included: Number of joints with active arthritis and limited range of motion, disease activity, parent child evaluation of overall well-being, functional ability, childhood health assessment questionnaire ( CHAQ disability index), erythrocyte sedimentation rate (ESR) millimeter/ hour (mm/hr), of the JIA core set with no more than one variable of the JIA core set improving by 30% compared to the day of randomization into the withdrawal phase. 95% Confidence Interval (CI) based on Brookmeyer and Crowley Method. |
| 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 | sJIA Flare was defined as at least one of the following criteria: recurrence of fever (\>38° C/100.4 degree F) on 2 or more consecutive days) was considered due to SJIA activity. Worsening of 30% or more in three or more of the six variables: number of joints with active arthritis and limited range of motion, disease activity, parent child evaluation of overall well-being, functional ability (CHAQ Disability Index), ESR. of the JIA core set with no more than one variable of the JIA core set improving by 30% compared to the day of randomization into the withdrawal phase. Probability of occurrence of sJIA disease flare with 95% CI were estimated using Kaplan-Meier method and reported in this outcome measure. |
| 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 | A successfully tapered participant was considered as the one that completed part 2 of the OL by reaching their target corticosteroid dose and maintained an adapted JIA American College of Rheumatology (ACR) 30 response for four weeks on this dose. The target CS dose at the end of part 2 included less than equal to (\<=) 0.5 milligram/kilogram/day (mg/kg/day) up to a maximum dose of 15 milligram/ day (mg/day) oral prednisone (or equivalent) for CS\>0.8 mg/kg/day oral prednisone; reduction to \<=0.3 mg/kg/day up to a maximum of 12 mg/day oral prednisone (or equivalent) for CS \<=0.8 mg/kg/day to greater than equal to (\>=) 0.5 mg/kg/day oral prednisone (or equivalent) and \<=0.2 mg/kg/day up to a maximum dose of 10 mg/day oral prednisone (or equivalent) for CS \<0.5 mg/kg/day-CS˃0.2 mg/kg/day oral prednisone (or equivalent). 95% CI was based on normal approximation. |
| 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 | 95% CI was based on normal approximation. |
| 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 | Adapted JIA ACR 30,50,70,90,100 response=absence of fever due to sJIA in preceding 7 days along with improvement of \>=30,50,70,90,100%, respectively in at least 3 out of 6 JIA core set variables with no more than 1 JIA core set variable worsening by \>=30%.Variables included: number of joints with active arthritis(any joint with swelling, or absence of swelling, limitation of motion accompanied by either pain on motion or tenderness);number of joints with limited range of motion; physician global evaluation of disease activity on VAS from 0=no disease activity to 10=very severe disease activity, higher scores:greater disease activity; parent/legal guardian/child evaluation of overall well-being on VAS from 0=very well to 10mm=very poor, higher scores: worsen condition; functional ability (Disability Index ranged from 0=no or minimal physical dysfunction, 3=very severe physical dysfunction, higher scores:more physical dysfunction;ESR (mm/hr).Missing response was imputed as non-response. |
| 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 | Adapted JIA ACR 30,50,70,90,100 response=absence of fever due to sJIA in preceding 7 days along with improvement of \>=30,50,70,90,100%, respectively in at least 3 out of 6 JIA core set variables with no more than 1 JIA core set variable worsening by \>=30%.Variables included: number of joints with active arthritis(any joint with swelling, or absence of swelling, limitation of motion accompanied by either pain on motion or tenderness);number of joints with limited range of motion; physician global evaluation of disease activity on VAS from 0=no disease activity to 10=very severe disease activity, higher scores: greater disease activity; parent/legal guardian/child evaluation of overall well-being on VAS from 0=very well to 10mm=very poor, higher scores: worsen condition; functional ability (Disability Index ranged from 0=no or minimal physical dysfunction, 3=very severe physical dysfunction, higher scores: more physical dysfunction; ESR (mm/hr). |
| 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 | Adapted JIA ACR 30,50,70,90,100 response=absence of fever due to sJIA in preceding 7 days along with improvement of \>=30,50,70,90,100%, respectively in at least 3 out of 6 JIA core set variables with no more than 1 JIA core set variable worsening by \>=30%.Variables included: number of joints with active arthritis(any joint with swelling, or absence of swelling, limitation of motion accompanied by either pain on motion or tenderness);number of joints with limited range of motion; physician global evaluation of disease activity on VAS from 0=no disease activity to 10=very severe disease activity, higher scores: greater disease activity; parent/legal guardian/child evaluation of overall well-being on VAS from 0=very well to 10mm=very poor, higher scores: worsen condition; functional ability (Disability Index ranged from 0=no or minimal physical dysfunction, 3=very severe physical dysfunction, higher scores: more physical dysfunction; ESR (mm/hr). |
| 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 | Fever was defined as an oral temperature of ˃38 degree Celsius/100.4 degree Fahrenheit. 95% CI was based on normal approximation. |
| 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 | Percentage of participants with CRP \<= 10 milligrams per liter (mg/L) along with 95% CI based on normal approximation is reported in this outcome. |
| 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 | Percentage of participants with CRP \<= 10 mg/L along with 95% CI based on normal approximation is reported in this outcome. |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 registered outcomesOutcomes65
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 outcomesResults by group1,057
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase | Tofacitinib 5mg BID DB | NA | 95% Confidence Interval 186.0 to NA | Days | |
| Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase | Placebo DB | 295.0 | 95% Confidence Interval 99.0 to NA | Days | |
| 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 | Tofacitinib 5mg BID DB | DB Week 4 | 7.1 | Percentage probability of occurrence | |
| 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 | Placebo DB | DB Week 4 | 6.5 | Percentage probability of occurrence | |
| 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 | Tofacitinib 5mg BID DB | DB Week 8 | 14.3 | Percentage probability of occurrence | |
| 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 | Placebo DB | DB Week 8 | 22.6 | Percentage probability of occurrence | |
| 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 | Tofacitinib 5mg BID DB | DB Week 12 | 21.4 | Percentage probability of occurrence | |
| 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 | Placebo DB | DB Week 12 | 32.3 | Percentage probability of occurrence | |
| 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 | Tofacitinib 5mg BID DB | DB Week 16 | 25.0 | Percentage probability of occurrence | |
| 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 | Placebo DB | DB Week 16 | 38.7 | Percentage probability of occurrence |
1 to 10 of 1,057Source ClinicalTrials.gov
See all 1,057 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open Label Part 1 | STARTED | Tofacitinib 5mg BID Open-Label (OL) Part 1 | 100 | |
| Open Label Part 1 | STARTED | Tofacitinib 5mg BID OL Part 2 | 0 | |
| Open Label Part 1 | STARTED | Tofacitinib 5mg BID DB | 0 | |
| Open Label Part 1 | STARTED | Placebo DB | 0 | |
| Open Label Part 1 | COMPLETED | Tofacitinib 5mg BID Open-Label (OL) Part 1 | 76 | |
| Open Label Part 1 | COMPLETED | Tofacitinib 5mg BID OL Part 2 | 0 | |
| Open Label Part 1 | COMPLETED | Tofacitinib 5mg BID DB | 0 | |
| Open Label Part 1 | COMPLETED | Placebo DB | 0 | |
| Open Label Part 1 | NOT COMPLETED | Tofacitinib 5mg BID Open-Label (OL) Part 1 | 24 | |
| Open Label Part 1 | NOT COMPLETED | Tofacitinib 5mg BID OL Part 2 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events356
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Tofacitinib 5mg BID OL Part 1 | 3 | 100 | 3 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Tofacitinib 5mg BID OL Part 2 | 0 | 54 | 0 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Tofacitinib 5mg BID DB | 1 | 28 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo DB | 0 | 31 | 0 |
| other | Nausea | Gastrointestinal disorders | Tofacitinib 5mg BID OL Part 1 | 3 | 100 | 4 |
| other | Nausea | Gastrointestinal disorders | Tofacitinib 5mg BID OL Part 2 | 0 | 54 | 0 |
| other | Nausea | Gastrointestinal disorders | Tofacitinib 5mg BID DB | 0 | 28 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo DB | 0 | 31 | 0 |
| other | Vomiting | Gastrointestinal disorders | Tofacitinib 5mg BID OL Part 1 | 3 | 100 | 3 |
| other | Vomiting | Gastrointestinal disorders | Tofacitinib 5mg BID OL Part 2 | 0 | 54 | 0 |
1 to 10 of 356Source ClinicalTrials.gov
See all 356 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tofacitinib 5mg BID OL Part 1 | 0 | 100 |
| Total, all-cause mortality | Tofacitinib 5mg BID OL Part 2 | 0 | 54 |
| Total, all-cause mortality | Tofacitinib 5mg BID DB | 0 | 28 |
| Total, all-cause mortality | Placebo DB | 0 | 31 |
| Total, other adverse events | Tofacitinib 5mg BID OL Part 1 | 33 | 100 |
| Total, other adverse events | Tofacitinib 5mg BID OL Part 2 | 15 | 54 |
| Total, other adverse events | Tofacitinib 5mg BID DB | 23 | 28 |
| Total, other adverse events | Placebo DB | 25 | 31 |
| Total, serious adverse events | Tofacitinib 5mg BID OL Part 1 | 7 | 100 |
| Total, serious adverse events | Tofacitinib 5mg BID OL Part 2 | 0 | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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