Trial · NCT02592434
Efficacy Study Of Tofacitinib In Pediatric JIA Population
NCT02592434, Phase 3, Completed, Pfizer; results first posted 2020-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study Of Tofacitinib In Pediatric JIA Population. Trials, record NCT02592434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02592434
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study Of Tofacitinib In Pediatric JIA Population
- NCT number
- NCT02592434
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 225 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- CP-690,550 (tofacitinib), placebo
- First posted
- 2015-10-30
- Last updated
- 2020-04-13
- Other registries' IDs
- eudract:2015-001438-46
- Results first posted
- 2020-02-21
- Limitations and caveats
Data not reported for the PK endpoints, since the PK dataset will be combined together with PK data from other studies and analyze in a pooled analysis; the results of this pooled analysis will be reported separately.
Source ClinicalTrials.gov
Registered outcomes72
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44 | Week 44 | According to PRCSG/PRINTO, disease flare defined as worsening of \>=30 percent(%) in \>=3 of 6 variables of JIA core set, with no more than 1 variable improving by \>=30%. Six core variables: 1) Number of joints with active arthritis (joint with swelling/in absence of swelling, limited range of motion accompanied by pain/tenderness), 2)Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a Visual Analog Scale\[VAS\] of 0\[no activity\] to 10\[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0\[very well\] to 10\[very poor\], 5) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI): 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score,which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) Erythrocyte Sedimentation Rate(ESR). |
| Secondary | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44 | Week 44 | JIA ACR50 response defined as: \>=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by \>=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 \[no activity\] to 10 \[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 \[very well\] to 10 \[very poor\], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR. |
| Secondary | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44 | Week 44 | JIA ACR30 response defined as: \>=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by \>=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 \[no activity\] to 10 \[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 \[very well\] to 10 \[very poor\], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR. |
| Secondary | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44 | Week 44 | JIA ACR70 response defined as: \>=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by \>=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 \[no activity\] to 10 \[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 \[very well\] to 10 \[very poor\], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR. |
| Secondary | Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Score at Week 44 | Baseline, Week 44 | CHAQ is a valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from double-blind baseline at Week 44 in DI total score is reported. |
| Secondary | Open-Label Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 2, 4, 8, 12 and 18 | Weeks 2, 4, 8, 12 and 18 | According to PRCSG/PRINTO, disease flare defined as worsening of \>=30% in \>=3 of 6 variables of JIA core set, with no more than 1 variable improving by \>=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 \[no activity\] to 10 \[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 \[very well\] to 10 \[very poor\], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR. |
| Secondary | Double Blind Phase: Percentage of Participants With Disease Flare According to PRCSG/PRINTO Disease Flare Criteria at Week 20, 24, 28, 32, 36 and 40 | Weeks 20, 24, 28, 32, 36 and 40 | According to PRCSG/PRINTO, disease flare defined as worsening of \>=30% in \>=3 of 6 variables of JIA core set, with no more than 1 variable improving by \>=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 \[no activity\] to 10 \[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 \[very well\] to 10 \[very poor\], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR. |
| Secondary | Open-Label Phase: Time to Disease Flare | Day 1 up to week 18 | Time to disease flare:time (in days) from first dose of study drug until the day of disease flare in open-label phase. According to PRCSG/PRINTO, disease flare: worsening of \>=30% in \>=3 of 6 variables of JIA core set, with no more than 1 variable improving by \>=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 \[no activity\] to 10 \[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 \[very well\] to 10 \[very poor\], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR. |
| Secondary | Double Blind Phase: Time to Disease Flare | Day 1 of Week 19 up to week 44 | Time to disease flare: time (in days) from first dose of study drug until the day of disease flare in double blind phase. According to PRCSG/PRINTO, disease flare: worsening of \>=30% in \>=3 of 6 variables of JIA core set, with no more than 1 variable improving by \>=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 \[no activity\] to 10 \[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 \[very well\] to 10 \[very poor\], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR. |
| Secondary | Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Weeks 2, 4, 8, 12 and 18 | Weeks 2, 4, 8, 12 and 18 | JIA ACR30 response defined as: \>=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by \>=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 \[no activity\] to 10 \[maximum activity\]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 \[very well\] to 10 \[very poor\], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR. |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 registered outcomesOutcomes72
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44 | Week 44 | The Double Blind polyarticular course JIA analysis set (DBJAS) included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. | percentage of participants | NUMBER |
| SECONDARY | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44 | Week 44 | The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. | percentage of participants | NUMBER |
| SECONDARY | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44 | Week 44 | The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. | percentage of participants | NUMBER |
| SECONDARY | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44 | Week 44 | The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. | percentage of participants | NUMBER |
| SECONDARY | Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Score at Week 44 | Baseline, Week 44 | The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Open-Label Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 2, 4, 8, 12 and 18 | Weeks 2, 4, 8, 12 and 18 | The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, 'number analyzed' (n) signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Double Blind Phase: Percentage of Participants With Disease Flare According to PRCSG/PRINTO Disease Flare Criteria at Week 20, 24, 28, 32, 36 and 40 | Weeks 20, 24, 28, 32, 36 and 40 | The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. | percentage of participants | NUMBER |
| SECONDARY | Open-Label Phase: Time to Disease Flare | Day 1 up to week 18 | The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. | days | MEDIAN |
| SECONDARY | Double Blind Phase: Time to Disease Flare | Day 1 of Week 19 up to week 44 | The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. | days | MEDIAN |
| SECONDARY | Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Weeks 2, 4, 8, 12 and 18 | Weeks 2, 4, 8, 12 and 18 | The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, n signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 outcomesResults by group1,073
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44 | Tofacitinib: Double Blind Phase | 29.17 | percentage of participants | ||
Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44 | Placebo | 52.86 | percentage of participants | ||
| Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44 | Tofacitinib: Double Blind Phase | 66.67 | percentage of participants | ||
| Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44 | Placebo | 47.14 | percentage of participants | ||
| Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44 | Tofacitinib: Double Blind Phase | 70.83 | percentage of participants | ||
| Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44 | Placebo | 47.14 | percentage of participants | ||
| Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44 | Tofacitinib: Double Blind Phase | 54.17 | percentage of participants | ||
| Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44 | Placebo | 37.14 | percentage of participants | ||
| Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Score at Week 44 | Tofacitinib: Double Blind Phase | -0.09 | Standard Error 0.04 | units on a scale | |
| Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Score at Week 44 | Placebo | 0.03 | Standard Error 0.04 | units on a scale |
1 to 10 of 1,073Source ClinicalTrials.gov
See all 1,073 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Phase (18 Weeks) | STARTED | Tofacitinib: Open-Label Phase | 225 | |
| Open-Label Phase (18 Weeks) | STARTED | Tofacitinib: Double Blind Phase | 0 | |
| Open-Label Phase (18 Weeks) | STARTED | Placebo | 0 | |
| Open-Label Phase (18 Weeks) | Treated | Tofacitinib: Open-Label Phase | 225 | |
| Open-Label Phase (18 Weeks) | Treated | Tofacitinib: Double Blind Phase | 0 | |
| Open-Label Phase (18 Weeks) | Treated | Placebo | 0 | |
| Open-Label Phase (18 Weeks) | COMPLETED | Tofacitinib: Open-Label Phase | 185 | |
| Open-Label Phase (18 Weeks) | COMPLETED | Tofacitinib: Double Blind Phase | 0 | |
| Open-Label Phase (18 Weeks) | COMPLETED | Placebo | 0 | |
| Open-Label Phase (18 Weeks) | NOT COMPLETED | Tofacitinib: Open-Label Phase | 40 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events174
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 | Ear pain | Ear and labyrinth disorders | Tofacitinib: Open-Label Phase | 0 | 225 | |
| other | Ear pain | Ear and labyrinth disorders | Tofacitinib: Double Blind Phase | 2 | 88 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 1 | 85 | |
| other | Uveitis | Eye disorders | Tofacitinib: Open-Label Phase | 0 | 225 | |
| other | Uveitis | Eye disorders | Tofacitinib: Double Blind Phase | 0 | 88 | |
| other | Uveitis | Eye disorders | Placebo | 2 | 85 | |
| other | Disease progression | General disorders | Tofacitinib: Open-Label Phase | 5 | 225 | |
| other | Disease progression | General disorders | Tofacitinib: Double Blind Phase | 8 | 88 | |
| other | Disease progression | General disorders | Placebo | 13 | 85 | |
| other | Pyrexia | General disorders | Tofacitinib: Open-Label Phase | 11 | 225 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tofacitinib: Open-Label Phase | 0 | 225 |
| Total, all-cause mortality | Tofacitinib: Double Blind Phase | 0 | 88 |
| Total, all-cause mortality | Placebo | 0 | 85 |
| Total, other adverse events | Tofacitinib: Open-Label Phase | 108 | 225 |
| Total, other adverse events | Tofacitinib: Double Blind Phase | 57 | 88 |
| Total, other adverse events | Placebo | 57 | 85 |
| Total, serious adverse events | Tofacitinib: Open-Label Phase | 7 | 225 |
| Total, serious adverse events | Tofacitinib: Double Blind Phase | 1 | 88 |
| Total, serious adverse events | Placebo | 2 | 85 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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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