Phase 3
N=302
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01500551 ↗Enrolled (actual)
302
Serious AEs
15.9%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participants With Laboratory Test Abnormalities — 294 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tofacitinib (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Laboratory Test Abnormalities |
294 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
268 | — |
| PRIMARY Absolute Values of Body Weight at Baseline |
41.60 | — |
| PRIMARY Absolute Value of Body Weight at Month 12 and Its Change From Baseline at Month 12 |
49.16; 6.52 | — |
| PRIMARY Absolute Value of Body Weight at Month 24 and Its Change From Baseline at Month 24 |
52.42; 9.42 | — |
| PRIMARY Absolute Value of Body Weight at Month 36 and Its Change From Baseline at Month 36 |
56.96; 12.44 | — |
| PRIMARY Absolute Value of Body Weight at Month 48 and Its Change From Baseline at Month 48 |
56.72; 13.99 | — |
| PRIMARY Absolute Value of Body Weight at Month 60 and Its Change From Baseline at Month 60 |
58.07; 17.50 | — |
| PRIMARY Absolute Value of Body Weight at Month 72 and Its Change From Baseline at Month 72 |
58.38; 20.55 | — |
| PRIMARY Absolute Value of Body Weight at Month 84 and Its Change From Baseline at Month 84 |
59.31; 23.80 | — |
| PRIMARY Absolute Value of Height at Baseline |
141.36 | — |
| PRIMARY Absolute Value of Height at Month 12 and Its Change From Baseline at Month 12 |
147.87; 5.55 | — |
| PRIMARY Absolute Value of Height at Month 24 and Its Change From Baseline at Month 24 |
151.60; 9.30 | — |
| PRIMARY Absolute Value of Height at Month 36 and Its Change From Baseline at Month 36 |
155.76; 10.97 | — |
| PRIMARY Absolute Value of Height at Month 48 and Its Change From Baseline at Month 48 |
157.82; 14.07 | — |
| PRIMARY Absolute Value of Height at Month 60 and Its Change From Baseline at Month 60 |
158.92; 17.71 | — |
| PRIMARY Absolute Value of Height at Month 72 and Its Change From Baseline at Month 72 |
159.76; 22.92 | — |
| PRIMARY Absolute Value of Height at Month 84 and Its Change From Baseline at Month 84 |
163.15; 27.95 | — |
| PRIMARY Number of Participants According to Tanner Stage at Baseline |
12; 12; 26; 26; 3; 3 | — |
| PRIMARY Number of Participants With Shift in Tanner Stage From Baseline to Month 12 |
11; 11; 18; 6; 2; 1 | — |
| PRIMARY Number of Participants With Shift in Tanner Stage From Baseline to Month 24 |
7; 7; 8; 3; 1; 1 | — |
| PRIMARY Number of Participants With Shift in Tanner Stage From Baseline to Month 36 |
3; 3; 5; 1; 1; 1 | — |
| PRIMARY Number of Participants With Shift in Tanner Stage From Baseline to Month 48 |
1; 1; 3; 2; 1; 2 | — |
| PRIMARY Number of Participants With Shift in Tanner Stage From Baseline to Month 60 |
1; 1; 1; 3; 1; 1 | — |
| PRIMARY Number of Participants With Shift in Tanner Stage From Baseline to Month 72 |
1; 1; 2; 1; 1; 2 | — |
| PRIMARY Number of Participants With Shift in Tanner Stage From Baseline to Month 84 |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Systemic Juvenile Idiopathic Arthritis (sJIA) 1 Analysis Set |
-4.44; -4.95; -5.33; -5.02; -5.13; -4.49 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-4.56; -5.07; -5.24; -5.01; -4.98; -4.39 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-4.24; -4.71; -4.79; -4.94; -4.98; -5.20 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Enthesitis Related Arthritis (ERA) Analysis Set |
-4.00; -3.76; -3.37; -4.13; -3.80; -3.96 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Psoriatic Arthritis (PsA) Analysis Set |
-4.18; -4.36; -4.84; -5.00; -4.75; -4.70 | — |
| SECONDARY Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-7.31; -7.65; -8.69; -8.65; -10.15; -9.08 | — |
| SECONDARY Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-7.03; -7.68; -8.28; -8.33; -9.72; -8.53 | — |
| SECONDARY Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-9.64; -10.36; -10.44; -10.45; -10.98; -10.87 | — |
| SECONDARY Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-6.71; -6.24; -6.16; -6.87; -7.07; -7.54 | — |
| SECONDARY Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-8.68; -9.28; -9.94; -10.00; -9.75; -9.93 | — |
| SECONDARY Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-3.60; -3.85; -4.21; -4.40; -5.02; -5.50 | — |
| SECONDARY Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-3.26; -3.50; -3.65; -3.99; -4.68; -4.78 | — |
| SECONDARY Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-5.48; -5.97; -6.13; -6.25; -6.22; -6.72 | — |
| SECONDARY Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-4.48; -4.29; -4.00; -5.13; -5.53; -6.08 | — |
| SECONDARY Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-5.00; -5.06; -5.63; -5.50; -4.88; -5.07 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-2.29; -2.43; -2.67; -2.22; -2.25; -2.50 | — |
| SECONDARY Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-2.50; -2.76; -2.84; -2.33; -2.34; -2.87 | — |
| SECONDARY Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-0.78; -0.71; -0.79; -0.77; -0.71; -0.71 | — |
| SECONDARY Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-0.09; -0.07; -0.09; 0.01; 0.19; 0.08 | — |
| SECONDARY Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-0.37; -0.63; -0.66; -0.64; -0.64; -0.32 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-28.69; -32.32; -34.61; -29.47; -27.54; -25.53 | — |
| SECONDARY Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-30.49; -34.05; -36.21; -30.55; -29.17; -26.74 | — |
| SECONDARY Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-10.48; -10.52; -10.01; -11.31; -8.75; -11.53 | — |
| SECONDARY Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-5.74; -6.84; -5.89; -3.53; -0.87; -3.31 | — |
| SECONDARY Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-10.00; -9.33; -12.27; -12.60; -12.13; -8.67 | — |
| SECONDARY Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-0.87; -0.90; -0.96; -1.00; -0.83; -0.86 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-0.89; -0.94; -0.96; -1.01; -0.85; -0.85 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-0.52; -0.52; -0.59; -0.63; -0.65; -0.71 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-0.38; -0.31; -0.34; -0.40; -0.39; -0.38 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-0.48; -0.44; -0.44; -0.37; -0.41; -0.37 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-4.54; -4.94; -5.16; -5.23; -4.93; -4.59 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-4.70; -5.19; -5.26; -5.33; -5.06; -4.89 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-3.16; -3.28; -3.60; -3.66; -3.74; -3.76 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-3.32; -2.50; -3.25; -3.00; -3.77; -2.50 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-4.07; -4.34; -4.77; -3.60; -4.70; -3.90 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-4.53; -5.04; -5.11; -5.38; -4.85; -4.44 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-4.71; -5.32; -5.25; -5.51; -5.12; -4.83 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-2.83; -3.01; -3.34; -3.36; -3.38; -3.47 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-1.32; -1.69; -2.03; -2.93; -2.27; -2.62 | — |
| SECONDARY Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-2.96; -3.03; -3.43; -2.60; -3.17; -2.53 | — |
| SECONDARY Percentage of Participants Achieving a JIA American College of Rheumatology 30 (ACR 30) Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
84.71; 86.59; 92.31; 94.74; 94.92; 85.42 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
84.42; 87.84; 91.67; 94.20; 96.15; 85.00 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
89.84; 89.05; 92.91; 92.25; 92.86; 95.59 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
90.91; 85.71; 87.50; 92.31; 86.67; 92.31 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
86.67; 93.33; 100.00; 93.33; 93.33; 80.00 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
75.58; 82.93; 91.03; 86.84; 89.83; 83.33 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
77.92; 85.14; 90.28; 88.41; 92.31; 85.00 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
79.84; 83.94; 87.23; 87.32; 87.86; 90.44 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
72.73; 85.71; 87.50; 92.31; 80.00; 84.62 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
80.00; 86.67; 100.00; 93.33; 86.67; 80.00 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
63.95; 71.95; 78.21; 76.32; 76.27; 68.75 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
66.23; 74.32; 79.17; 76.81; 76.92; 72.50 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
60.00; 67.63; 73.05; 71.83; 73.05; 78.36 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
58.33; 46.67; 76.47; 76.92; 60.00; 61.54 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
52.94; 86.67; 73.33; 80.00; 86.67; 66.67 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
40.23; 51.19; 48.10; 49.35; 48.33; 43.75 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
42.86; 55.41; 50.00; 49.28; 49.06; 47.50 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
33.57; 36.99; 43.45; 48.25; 45.00; 54.48 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
30.77; 18.75; 33.33; 40.00; 33.33; 46.15 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
44.44; 58.82; 53.33; 53.33; 60.00; 60.00 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
26.44; 36.90; 37.97; 32.47; 31.67; 35.42 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
27.27; 39.19; 38.89; 33.33; 32.08; 37.50 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
26.57; 29.93; 38.10; 39.86; 40.29; 46.67 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
28.57; 17.65; 33.33; 33.33; 26.67; 46.15 | — |
| SECONDARY Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
38.89; 41.18; 53.33; 40.00; 33.33; 53.33 | — |
| SECONDARY Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
5.0; 9.3; 1.7; 8.2; 7.9; 0 | — |
| SECONDARY Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
5.6; 10.1; 1.9; 9.8; 6.3; 0 | — |
| SECONDARY Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
3.9; 4.8; 5.6; 3.6; 2.3; 3.9 | — |
| SECONDARY Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
5.9; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
0; 7.1; 6.7; 0; 0; 8.3 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
13.79; 16.67; 17.72; 19.74; 25.00; 25.53 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
14.47; 16.44; 16.90; 19.12; 24.53; 25.64 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
22.22; 28.09; 30.12; 32.91; 31.41; 33.56 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
20.00; 19.05; 31.58; 26.67; 26.67; 38.46 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
22.22; 11.11; 33.33; 26.67; 18.75; 26.67 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
7.89; 5.00; 4.26; 10.26; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
8.82; 3.77; 5.13; 9.38; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
18.35; 4.49; 3.42; 5.15; 2.27; 3.31 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
13.33; 6.67; 0; 8.33; 18.18; 0 | — |
| SECONDARY Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
6.67; 0; 6.67; 7.69; 15.38; 0 | — |
| SECONDARY Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-16.58; -17.82; -19.46; -19.07; -20.11; -18.25 | — |
| SECONDARY Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-16.86; -18.72; -19.36; -19.05; -19.91; -18.49 | — |
| SECONDARY Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-15.45; -16.29; -17.42; -17.17; -17.81; -18.00 | — |
| SECONDARY Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-8.80; -8.49; -9.61; -11.23; -10.16; -11.12 | — |
| SECONDARY Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-12.55; -13.69; -14.62; -14.08; -14.51; -13.58 | — |
| SECONDARY Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
-16.98; -18.33; -20.06; -19.38; -20.02; -17.94 | — |
| SECONDARY Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
-17.22; -19.16; -19.97; -19.32; -19.85; -17.86 | — |
| SECONDARY Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set |
-15.30; -16.39; -17.39; -17.25; -17.73; -18.00 | — |
| SECONDARY Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
-8.95; -8.76; -10.11; -11.51; -10.30; -11.48 | — |
| SECONDARY Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
-13.73; -13.96; -15.02; -14.58; -14.90; -14.25 | — |
| SECONDARY Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
43.2; 55.6; 56.4; 55.3; 54.2; 48.9 | — |
| SECONDARY Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
43.2; 57.5; 55.6; 55.1; 51.9; 48.7 | — |
| SECONDARY Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78:Participants in pJIA Analysis Set |
52.0; 58.1; 61.4; 58.7; 66.0; 66.4 | — |
| SECONDARY Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
54.5; 35.7; 43.8; 64.3; 46.7; 69.2 | — |
| SECONDARY Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
66.7; 64.3; 66.7; 60.0; 80.0; 66.7 | — |
| SECONDARY Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
24.7; 30.9; 30.8; 28.9; 28.8; 29.8 | — |
| SECONDARY Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
24.3; 31.5; 30.6; 27.5; 25.0; 33.3 | — |
| SECONDARY Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and ESR Score at Months 1,3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78:Participants in pJIA Analysis Set |
28.8; 35.3; 36.4; 38.5; 36.9; 37.3 | — |
| SECONDARY Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set |
36.4; 14.3; 31.3; 28.6; 40.0; 15.4 | — |
| SECONDARY Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set |
26.7; 35.7; 53.3; 26.7; 53.3; 26.7 | — |
| SECONDARY Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in sJIA1 Analysis Set |
12.05; 3.61; 8.43; 30.00; 70.00; 3.61 | — |
| SECONDARY Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in sJIA2 Analysis Set |
10.39; 3.90; 6.49; 37.50; 62.50; 3.90 | — |
| SECONDARY Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in pJIA Analysis Set |
8.90; 2.05; 6.85; 23.08; 76.92; 12.93 | — |
| SECONDARY Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in ERA Analysis Set |
0; 0; 0; 7.69; 0; 7.69 | — |
| SECONDARY Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in PsA Analysis Set |
6.67; 0; 6.67; 0; 100; 13.33 | — |
| SECONDARY Percentage of Participants Who Achieved Absence of Fever 1 Week Prior to Assessment at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set |
95.35; 97.59; 100; 97.44; 100; 97.96 | — |
| SECONDARY Percentage of Participants Who Achieved Absence of Fever 1 Week Prior to Assessment at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set |
94.81; 97.30; 100; 97.14; 100; 97.56 | — |
| SECONDARY Change From Baseline in Tender Entheseal Assessment at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set |
-4.47; -4.83; -4.33; -5.08; -5.33; -4.75 | — |
| SECONDARY Change From Baseline in Modified Schober's Test at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set |
0.37; 0.34; 0.20; 0.29; 0.09; -0.87 | — |
| SECONDARY Change From Baseline in Overall Back Pain at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set |
-3.18; -2.78; -3.57; -3.83; -3.70; -3.11 | — |
| SECONDARY Change From Baseline in Nocturnal Back Pain at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set |
-2.16; -1.78; -2.67; -3.04; -3.10; -2.44 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) at Months 3, 6, 12, 18, 24, 30 and 36: Participants in PsA Analysis Set |
-1.81; -2.03; -1.89; -1.73; -2.00; -1.77 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment (PGA) at Months 3, 6, 12, 18, 24, 30 and 36: Participants in PsA Analysis Set |
-0.56; -0.60; -0.71; -0.67; -0.64; -0.69 | — |
Summary
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
Eligibility Criteria
Inclusion Criteria
- Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
- The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
- Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
- Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.
Exclusion Criteria
- persistent oligoarthritis, and undifferentiated JIA.
- Infections:
- Chronic infections.
- Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug.
- Any treated infections within 2 weeks of baseline visit.
- A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
- History of infected joint prosthesis with prosthesis still in situ.
- History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
Data sourced from ClinicalTrials.gov (NCT01500551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.