Trial Outcomes & Findings for A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA (NCT NCT03000439)
NCT ID: NCT03000439
Last Updated: 2025-06-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
From randomization up to 248 weeks
Results posted on
2025-06-03
Participant Flow
Participants who were diagnosed with Systemic Juvenile Idiopathic Arthritis (sJIA) with active systemic features were enrolled.
A total of 168 participants were screened, of which 68 failed screening and only 100 participants were enrolled in open label part 1 (OLP1). From the total of 100 participants enrolled into OLP1 of the study, 54 participants were treated in open label part 2 (OLP2), and 59 participants were randomized between the treatment groups in the double-blinded (DB) phase.
Participant milestones
| Measure |
Tofacitinib 5mg BID Open-Label (OL) Part 1
Participants were administered tofacitinib 5 milligram (mg) twice a day (BID) via the oral route and continued to receive a stable dose of corticosteroids (Cs) during open label part 1.
|
Tofacitinib 5mg BID OL Part 2
Participants who achieved sJIA American college of rheumatology (ACR) 50 response and maintained sJIA ACR 30 response for 4 weeks were administered tofacitinib 5 mg BID and tapering dose of CSs for participants treated with greater than (˃0.2) milligram/kilogram/day (mg/kg/day) oral prednisone (or equivalent).
|
Tofacitinib 5mg BID DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the open-label phase continued to receive tofacitinib 5 mg BID orally during the double-blind withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the open-label phase were randomized to receive placebo BID orally during the double-blind withdrawal phase of the study.
|
|---|---|---|---|---|
|
Open Label Part 1
STARTED
|
100
|
0
|
0
|
0
|
|
Open Label Part 1
COMPLETED
|
76
|
0
|
0
|
0
|
|
Open Label Part 1
NOT COMPLETED
|
24
|
0
|
0
|
0
|
|
Open Label Part 2
STARTED
|
0
|
54
|
0
|
0
|
|
Open Label Part 2
COMPLETED
|
0
|
37
|
0
|
0
|
|
Open Label Part 2
NOT COMPLETED
|
0
|
17
|
0
|
0
|
|
Double Blind Phase
STARTED
|
0
|
0
|
28
|
31
|
|
Double Blind Phase
COMPLETED
|
0
|
0
|
14
|
17
|
|
Double Blind Phase
NOT COMPLETED
|
0
|
0
|
14
|
14
|
Reasons for withdrawal
| Measure |
Tofacitinib 5mg BID Open-Label (OL) Part 1
Participants were administered tofacitinib 5 milligram (mg) twice a day (BID) via the oral route and continued to receive a stable dose of corticosteroids (Cs) during open label part 1.
|
Tofacitinib 5mg BID OL Part 2
Participants who achieved sJIA American college of rheumatology (ACR) 50 response and maintained sJIA ACR 30 response for 4 weeks were administered tofacitinib 5 mg BID and tapering dose of CSs for participants treated with greater than (˃0.2) milligram/kilogram/day (mg/kg/day) oral prednisone (or equivalent).
|
Tofacitinib 5mg BID DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the open-label phase continued to receive tofacitinib 5 mg BID orally during the double-blind withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the open-label phase were randomized to receive placebo BID orally during the double-blind withdrawal phase of the study.
|
|---|---|---|---|---|
|
Open Label Part 1
Adverse Event
|
6
|
0
|
0
|
0
|
|
Open Label Part 1
Other
|
2
|
0
|
0
|
0
|
|
Open Label Part 1
Insufficient clinical response
|
16
|
0
|
0
|
0
|
|
Open Label Part 2
Other
|
0
|
5
|
0
|
0
|
|
Open Label Part 2
Insufficient clinical response
|
0
|
12
|
0
|
0
|
|
Double Blind Phase
Adverse Event
|
0
|
0
|
2
|
1
|
|
Double Blind Phase
Withdrawal by parent/guardian
|
0
|
0
|
2
|
0
|
|
Double Blind Phase
Other
|
0
|
0
|
10
|
11
|
|
Double Blind Phase
Insufficient clinical response
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
Baseline characteristics by cohort
| Measure |
Overall
n=100 Participants
All participants who received at least one dose of investigational product in the study.
|
|---|---|
|
Age, Customized
2 to less than (<) 6 Years
|
17 Participants
n=5 Participants
|
|
Age, Customized
6 to < 12 Years
|
43 Participants
n=5 Participants
|
|
Age, Customized
12 to < 18 Years
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
86 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization up to 248 weeksPopulation: Double blind full analysis set (DBFAS) consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
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.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase
|
NA Days
Interval 186.0 to
Median and upper limit of 95% CI were not estimated due to insufficient number of participants with event.
|
295.0 Days
Interval 99.0 to
Upper limit of 95% CI was not estimated due to insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
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.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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 Week 4
|
7.1 Percentage probability of occurrence
|
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
DB Week 8
|
14.3 Percentage probability of occurrence
|
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
DB Week 12
|
21.4 Percentage probability of occurrence
|
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
DB Week 16
|
25.0 Percentage probability of occurrence
|
38.7 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
DB Week 20
|
32.1 Percentage probability of occurrence
|
45.4 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
DB Week 24
|
32.1 Percentage probability of occurrence
|
45.4 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
DB Week 28
|
35.9 Percentage probability of occurrence
|
45.4 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
DB Week 32
|
35.9 Percentage probability of occurrence
|
49.9 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
DB Week 36
|
40.5 Percentage probability of occurrence
|
49.9 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
DB Week 40
|
40.5 Percentage probability of occurrence
|
49.9 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
DB Week 44
|
40.5 Percentage probability of occurrence
|
55.5 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
DB Week 48
|
40.5 Percentage probability of occurrence
|
55.5 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
DB Week 52
|
40.5 Percentage probability of occurrence
|
55.5 Percentage probability of occurrence
|
SECONDARY outcome
Timeframe: From end of OL Part 1 to up to 24 weeks in OL Part 2Population: 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.
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.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants Who Achieved Successful Corticosteroid Tapering: at the End of Open-label Phase Part 2
|
70.37 Percentage of participants
Interval 58.19 to 82.55
|
—
|
SECONDARY outcome
Timeframe: From end of OL Part 1 to up to 24 weeks in OL Part 2Population: 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.
95% CI was based on normal approximation.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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
|
59.26 Percentage of participants
Interval 46.15 to 72.36
|
—
|
SECONDARY outcome
Timeframe: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
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.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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
ACR100:DB Week 12
|
14.29 Percentage of participants
Interval 1.32 to 27.25
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR100:DB Week 16
|
17.86 Percentage of participants
Interval 3.67 to 32.04
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR100:DB Week 20
|
14.29 Percentage of participants
Interval 1.32 to 27.25
|
12.90 Percentage of participants
Interval 1.1 to 24.7
|
|
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
ACR100:DB Week 24
|
17.86 Percentage of participants
Interval 3.67 to 32.04
|
19.35 Percentage of participants
Interval 5.45 to 33.26
|
|
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
ACR100:DB Week 28
|
14.29 Percentage of participants
Interval 1.32 to 27.25
|
22.58 Percentage of participants
Interval 7.86 to 37.3
|
|
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
ACR100:DB Week 32
|
10.71 Percentage of participants
Interval 0.0 to 22.17
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR100:DB Week 36
|
14.29 Percentage of participants
Interval 1.32 to 27.25
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR100:DB Week 40
|
21.43 Percentage of participants
Interval 6.23 to 36.63
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
|
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
ACR100:DB Week 44
|
21.43 Percentage of participants
Interval 6.23 to 36.63
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR100:DB Week 48
|
25.00 Percentage of participants
Interval 8.96 to 41.04
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR100:DB Week 52
|
25.00 Percentage of participants
Interval 8.96 to 41.04
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR30:DB Week 4
|
82.14 Percentage of participants
Interval 67.96 to 96.33
|
93.55 Percentage of participants
Interval 84.9 to 100.0
|
|
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
ACR30:DB Week 8
|
82.14 Percentage of participants
Interval 67.96 to 96.33
|
80.65 Percentage of participants
Interval 66.74 to 94.55
|
|
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
ACR30:DB Week 12
|
71.43 Percentage of participants
Interval 54.7 to 88.16
|
70.97 Percentage of participants
Interval 54.99 to 86.95
|
|
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
ACR30:DB Week 16
|
71.43 Percentage of participants
Interval 54.7 to 88.16
|
61.29 Percentage of participants
Interval 44.14 to 78.44
|
|
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
ACR30:DB Week 20
|
67.86 Percentage of participants
Interval 50.56 to 85.16
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR30:DB Week 24
|
64.29 Percentage of participants
Interval 46.54 to 82.03
|
54.84 Percentage of participants
Interval 37.32 to 72.36
|
|
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
ACR30:DB Week 28
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR30:DB Week 32
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR30:DB Week 36
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR30:DB Week 40
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR30:DB Week 44
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR30:DB Week 48
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR30:DB Week 52
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR50:DB Week 4
|
82.14 Percentage of participants
Interval 67.96 to 96.33
|
93.55 Percentage of participants
Interval 84.9 to 100.0
|
|
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
ACR50:DB Week 8
|
82.14 Percentage of participants
Interval 67.96 to 96.33
|
77.42 Percentage of participants
Interval 62.7 to 92.14
|
|
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
ACR50:DB Week 12
|
71.43 Percentage of participants
Interval 54.7 to 88.16
|
70.97 Percentage of participants
Interval 54.99 to 86.95
|
|
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
ACR50:DB Week 16
|
71.43 Percentage of participants
Interval 54.7 to 88.16
|
58.06 Percentage of participants
Interval 40.69 to 75.44
|
|
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
ACR50:DB Week 20
|
67.86 Percentage of participants
Interval 50.56 to 85.16
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR50:DB Week 24
|
64.29 Percentage of participants
Interval 46.54 to 82.03
|
54.84 Percentage of participants
Interval 37.32 to 72.36
|
|
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
ACR50:DB Week 28
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR50:DB Week 32
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR50:DB Week 36
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR50:DB Week 40
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR50:DB Week 44
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR50:DB Week 48
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR50:DB Week 52
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR70:DB Week 4
|
57.14 Percentage of participants
Interval 38.81 to 75.47
|
70.97 Percentage of participants
Interval 54.99 to 86.95
|
|
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
ACR70:DB Week 8
|
67.86 Percentage of participants
Interval 50.56 to 85.16
|
77.42 Percentage of participants
Interval 62.7 to 92.14
|
|
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
ACR70:DB Week 12
|
64.29 Percentage of participants
Interval 46.54 to 82.03
|
64.52 Percentage of participants
Interval 47.67 to 81.36
|
|
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
ACR70:DB Week 16
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
54.84 Percentage of participants
Interval 37.32 to 72.36
|
|
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
ACR70:DB Week 20
|
64.29 Percentage of participants
Interval 46.54 to 82.03
|
45.16 Percentage of participants
Interval 27.64 to 62.68
|
|
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
ACR70:DB Week 24
|
53.57 Percentage of participants
Interval 35.1 to 72.04
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR70:DB Week 28
|
57.14 Percentage of participants
Interval 38.81 to 75.47
|
41.94 Percentage of participants
Interval 24.56 to 59.31
|
|
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
ACR70:DB Week 32
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR70:DB Week 36
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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
ACR70:DB Week 40
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR70:DB Week 44
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR70:DB Week 48
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR70:DB Week 52
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR90:DB Week 4
|
28.57 Percentage of participants
Interval 11.84 to 45.3
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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
ACR90:DB Week 8
|
21.43 Percentage of participants
Interval 6.23 to 36.63
|
38.71 Percentage of participants
Interval 21.56 to 55.86
|
|
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
ACR90:DB Week 12
|
25.00 Percentage of participants
Interval 8.96 to 41.04
|
38.71 Percentage of participants
Interval 21.56 to 55.86
|
|
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
ACR90:DB Week 16
|
25.00 Percentage of participants
Interval 8.96 to 41.04
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
|
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
ACR90:DB Week 20
|
21.43 Percentage of participants
Interval 6.23 to 36.63
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
|
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
ACR90:DB Week 24
|
21.43 Percentage of participants
Interval 6.23 to 36.63
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR90:DB Week 28
|
17.86 Percentage of participants
Interval 3.67 to 32.04
|
25.81 Percentage of participants
Interval 10.4 to 41.21
|
|
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
ACR90:DB Week 32
|
14.29 Percentage of participants
Interval 1.32 to 27.25
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
|
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
ACR90:DB Week 36
|
28.57 Percentage of participants
Interval 11.84 to 45.3
|
35.48 Percentage of participants
Interval 18.64 to 52.33
|
|
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
ACR90:DB Week 40
|
28.57 Percentage of participants
Interval 11.84 to 45.3
|
32.26 Percentage of participants
Interval 15.8 to 48.71
|
|
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
ACR90:DB Week 44
|
28.57 Percentage of participants
Interval 11.84 to 45.3
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
|
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
ACR90:DB Week 48
|
28.57 Percentage of participants
Interval 11.84 to 45.3
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
|
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
ACR90:DB Week 52
|
28.57 Percentage of participants
Interval 11.84 to 45.3
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
|
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
ACR100:DB Week 4
|
14.29 Percentage of participants
Interval 1.32 to 27.25
|
35.48 Percentage of participants
Interval 18.64 to 52.33
|
|
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
ACR100:DB Week 8
|
10.71 Percentage of participants
Interval 0.0 to 22.17
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
SECONDARY outcome
Timeframe: Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12, and 16Population: 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.
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).
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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
ACR30: Part 1 Day 7
|
26.26 Percentage of participants
Interval 17.59 to 34.93
|
—
|
|
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
ACR30: Part 1 Week 2
|
42.42 Percentage of participants
Interval 32.69 to 52.16
|
—
|
|
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
ACR30: Part 1 Week 4
|
68.04 Percentage of participants
Interval 58.76 to 77.32
|
—
|
|
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
ACR30: Part 1 Week 8
|
86.59 Percentage of participants
Interval 79.21 to 93.96
|
—
|
|
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
ACR30:Part 1 Week 12
|
90.91 Percentage of participants
Interval 82.41 to 99.4
|
—
|
|
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
ACR30: Part 1 Week 16
|
83.33 Percentage of participants
Interval 68.42 to 98.24
|
—
|
|
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
ACR50:Part 1 Day 7
|
18.18 Percentage of participants
Interval 10.58 to 25.78
|
—
|
|
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
ACR50:Part 1 Week 2
|
28.28 Percentage of participants
Interval 19.41 to 37.15
|
—
|
|
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
ACR50:Part 1 Week 4
|
44.33 Percentage of participants
Interval 34.44 to 54.22
|
—
|
|
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
ACR50:Part 1 Week 8
|
59.04 Percentage of participants
Interval 48.46 to 69.62
|
—
|
|
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
ACR50:Part 1 Week 12
|
79.55 Percentage of participants
Interval 67.63 to 91.46
|
—
|
|
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
ACR50:Part 1 Week 16
|
75.00 Percentage of participants
Interval 57.68 to 92.32
|
—
|
|
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
ACR70:Part 1 Day 7
|
10.10 Percentage of participants
Interval 4.16 to 16.04
|
—
|
|
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
ACR70:Part 1 Week 2
|
16.16 Percentage of participants
Interval 8.91 to 23.41
|
—
|
|
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
ACR70:Part 1 Week 4
|
19.59 Percentage of participants
Interval 11.69 to 27.49
|
—
|
|
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
ACR70:Part 1 Week 8
|
34.15 Percentage of participants
Interval 23.88 to 44.41
|
—
|
|
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
ACR70:Part 1 Week 12
|
38.64 Percentage of participants
Interval 24.25 to 53.02
|
—
|
|
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
ACR70:Part 1 Week 16
|
33.33 Percentage of participants
Interval 14.47 to 52.19
|
—
|
|
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
ACR90:Part 1 Day 7
|
5.05 Percentage of participants
Interval 0.74 to 9.36
|
—
|
|
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
ACR90:Part 1 Week 2
|
6.06 Percentage of participants
Interval 1.36 to 10.76
|
—
|
|
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
ACR90:Part 1 Week 4
|
11.34 Percentage of participants
Interval 5.03 to 17.65
|
—
|
|
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
ACR90:Part 1 Week 8
|
18.29 Percentage of participants
Interval 9.92 to 26.66
|
—
|
|
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
ACR90:Part 1 Week 12
|
15.91 Percentage of participants
Interval 5.1 to 26.72
|
—
|
|
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
ACR90:Part 1 Week 16
|
16.67 Percentage of participants
Interval 1.76 to 31.58
|
—
|
|
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
ACR100:Part 1 Day 7
|
3.03 Percentage of participants
Interval 0.0 to 6.41
|
—
|
|
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
ACR100:Part 1 Week 2
|
5.05 Percentage of participants
Interval 0.74 to 9.36
|
—
|
|
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
ACR100:Part 1 Week 4
|
8.25 Percentage of participants
Interval 2.77 to 13.72
|
—
|
|
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
ACR100:Part 1 Week 8
|
13.41 Percentage of participants
Interval 6.04 to 20.79
|
—
|
|
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
ACR100:Part 1 Week 12
|
9.09 Percentage of participants
Interval 0.6 to 17.59
|
—
|
|
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
ACR100:Part 1 Week 16
|
8.33 Percentage of participants
Interval 0.0 to 19.39
|
—
|
SECONDARY outcome
Timeframe: Part 2 Weeks 4, 8, 12, 16, 20 and 24Population: 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.
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).
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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
ACR30:Part 2 Week 4
|
90.00 Percentage of participants
Interval 81.68 to 98.32
|
—
|
|
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
ACR30:Part 2 Week 8
|
87.50 Percentage of participants
Interval 77.25 to 97.75
|
—
|
|
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
ACR30:Part 2 Week 12
|
90.32 Percentage of participants
Interval 79.91 to 100.0
|
—
|
|
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
ACR30:Part 2 week 16
|
86.96 Percentage of participants
Interval 73.19 to 100.0
|
—
|
|
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
ACR30:Part 2 Week 20
|
100 Percentage of participants
Interval 100.0 to 100.0
|
—
|
|
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
ACR30:Part 2 Week 24
|
100 Percentage of participants
Interval 100.0 to 100.0
|
—
|
|
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
ACR50:Part 2 Week 4
|
86.00 Percentage of participants
Interval 76.38 to 95.62
|
—
|
|
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
ACR50:Part 2 Week 8
|
77.50 Percentage of participants
Interval 64.56 to 90.44
|
—
|
|
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
ACR50:Part 2 Week 12
|
80.65 Percentage of participants
Interval 66.74 to 94.55
|
—
|
|
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
ACR50:Part 2 Week 16
|
73.91 Percentage of participants
Interval 55.97 to 91.86
|
—
|
|
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
ACR50:Part 2 Week 20
|
92.31 Percentage of participants
Interval 77.82 to 100.0
|
—
|
|
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
ACR50:Part 2 Week 24
|
100 Percentage of participants
Interval 100.0 to 100.0
|
—
|
|
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
ACR70:Part 2 Week 4
|
68.00 Percentage of participants
Interval 55.07 to 80.93
|
—
|
|
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
ACR70:Part 2 Week 8
|
67.50 Percentage of participants
Interval 52.98 to 82.02
|
—
|
|
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
ACR70:Part 2 Week 12
|
70.97 Percentage of participants
Interval 54.99 to 86.95
|
—
|
|
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
ACR70:Part 2 Week 16
|
73.91 Percentage of participants
Interval 55.97 to 91.86
|
—
|
|
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
ACR70:Part 2 Week 20
|
92.31 Percentage of participants
Interval 77.82 to 100.0
|
—
|
|
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
ACR70:Part 2 Week 24
|
66.67 Percentage of participants
Interval 13.32 to 100.0
|
—
|
|
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
ACR90:Part 2 Week 4
|
32.00 Percentage of participants
Interval 19.07 to 44.93
|
—
|
|
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
ACR90:Part 2 Week 8
|
27.50 Percentage of participants
Interval 13.66 to 41.34
|
—
|
|
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
ACR90:Part 2 Week 12
|
22.58 Percentage of participants
Interval 7.86 to 37.3
|
—
|
|
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
ACR90:Part 2 Week 16
|
34.78 Percentage of participants
Interval 15.32 to 54.25
|
—
|
|
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
ACR90:Part 2 Week 20
|
53.85 Percentage of participants
Interval 26.75 to 80.95
|
—
|
|
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
ACR90:Part 2 Week 24
|
33.33 Percentage of participants
Interval 0.0 to 86.68
|
—
|
|
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
ACR100:Part 2 Week 4
|
28.00 Percentage of participants
Interval 15.55 to 40.45
|
—
|
|
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
ACR100:Part 2 Week 8
|
27.50 Percentage of participants
Interval 13.66 to 41.34
|
—
|
|
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
ACR100:Part 2 Week 12
|
16.13 Percentage of participants
Interval 3.18 to 29.08
|
—
|
|
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
ACR100:Part 2 Week 16
|
26.09 Percentage of participants
Interval 8.14 to 44.03
|
—
|
|
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
ACR100:Part 2 Week 20
|
38.46 Percentage of participants
Interval 12.01 to 64.91
|
—
|
|
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
ACR100:Part 2 Week 24
|
33.33 Percentage of participants
Interval 0.0 to 86.68
|
—
|
SECONDARY outcome
Timeframe: Part 1 Days 3, 7 and 14Population: 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.
Fever was defined as an oral temperature of ˃38 degree Celsius/100.4 degree Fahrenheit. 95% CI was based on normal approximation.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1
Part 1 Day 3
|
3.13 Percentage of participants
Interval 0.0 to 6.61
|
—
|
|
Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1
Part 1 Day 7
|
1.03 Percentage of participants
Interval 0.0 to 3.04
|
—
|
|
Percentage of Participants With Fever Attributed to sJIA at Part 1 Days 3, 7 and 14: Open-Label Phase Part 1
Part 1 Day 14
|
4.12 Percentage of participants
Interval 0.17 to 8.08
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to Day 1 of study treatment), Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16Population: 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 with CRP \<= 10 milligrams per liter (mg/L) along with 95% CI based on normal approximation is reported in this outcome.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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
|
30.00 Percentage of participants
Interval 21.02 to 38.98
|
—
|
|
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
Part 1 Day 3
|
32.63 Percentage of participants
Interval 23.2 to 42.06
|
—
|
|
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
Part 1 Day 7
|
45.36 Percentage of participants
Interval 35.45 to 55.27
|
—
|
|
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
Part 1 Week 2
|
49.48 Percentage of participants
Interval 39.53 to 59.43
|
—
|
|
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
Part 1 Week 4
|
55.67 Percentage of participants
Interval 45.78 to 65.56
|
—
|
|
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
Part 1 Week 8
|
60.00 Percentage of participants
Interval 49.26 to 70.74
|
—
|
|
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
Part 1 Week 12
|
59.09 Percentage of participants
Interval 44.56 to 73.62
|
—
|
|
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
Part 1 Week 16
|
41.67 Percentage of participants
Interval 21.94 to 61.39
|
—
|
SECONDARY outcome
Timeframe: Part 2 Weeks 4, 8, 12, 16, 20, 24Population: 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 with CRP \<= 10 mg/L along with 95% CI based on normal approximation is reported in this outcome.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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 Week 4
|
68.00 Percentage of participants
Interval 55.07 to 80.93
|
—
|
|
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 Week 8
|
62.50 Percentage of participants
Interval 47.5 to 77.5
|
—
|
|
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 Week 12
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
—
|
|
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 Week 16
|
54.55 Percentage of participants
Interval 33.74 to 75.35
|
—
|
|
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 Week 20
|
76.92 Percentage of participants
Interval 54.02 to 99.83
|
—
|
|
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 Week 24
|
33.33 Percentage of participants
Interval 0.0 to 86.68
|
—
|
SECONDARY outcome
Timeframe: Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12, 16Population: 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 with absence of fever along with 95% CI based on normal approximation is reported in this outcome.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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
|
83.51 Percentage of participants
Interval 76.12 to 90.89
|
—
|
|
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 Week 2
|
82.47 Percentage of participants
Interval 74.91 to 90.04
|
—
|
|
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 Week 4
|
90.72 Percentage of participants
Interval 84.95 to 96.5
|
—
|
|
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 Week 8
|
96.39 Percentage of participants
Interval 92.37 to 100.0
|
—
|
|
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 Week 12
|
100 Percentage of participants
Interval 100.0 to 100.0
|
—
|
|
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 Week 16
|
95.83 Percentage of participants
Interval 87.84 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Part 2 Weeks 4, 8, 12, 16, 20 and 24Population: 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 with absence of fever along with 95% CI based on normal approximation is reported in this outcome.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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 Week 4
|
98.00 Percentage of participants
Interval 94.12 to 100.0
|
—
|
|
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 Week 8
|
92.31 Percentage of participants
Interval 83.94 to 100.0
|
—
|
|
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 Week 12
|
96.77 Percentage of participants
Interval 90.55 to 100.0
|
—
|
|
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 Week 16
|
90.91 Percentage of participants
Interval 78.9 to 100.0
|
—
|
|
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 Week 20
|
100 Percentage of participants
Interval 100.0 to 100.0
|
—
|
|
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 Week 24
|
100 Percentage of participants
Interval 100.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
Percentage of participants with absence of fever due sJIA is reported in this outcome. Missing response was imputed as non-response.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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 Week 44
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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 Week 4
|
85.71 Percentage of participants
Interval 72.75 to 98.68
|
93.55 Percentage of participants
Interval 84.9 to 100.0
|
|
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 Week 8
|
85.71 Percentage of participants
Interval 72.75 to 98.68
|
80.65 Percentage of participants
Interval 66.74 to 94.55
|
|
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 Week 12
|
75.00 Percentage of participants
Interval 58.96 to 91.04
|
74.19 Percentage of participants
Interval 58.79 to 89.6
|
|
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 Week 16
|
71.43 Percentage of participants
Interval 54.7 to 88.16
|
61.29 Percentage of participants
Interval 44.14 to 78.44
|
|
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 Week 20
|
67.86 Percentage of participants
Interval 50.56 to 85.16
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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 Week 24
|
64.29 Percentage of participants
Interval 46.54 to 82.03
|
54.84 Percentage of participants
Interval 37.32 to 72.36
|
|
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 Week 28
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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 Week 32
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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 Week 36
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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 Week 40
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
51.61 Percentage of participants
Interval 34.02 to 69.21
|
|
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 Week 48
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
|
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 Week 52
|
60.71 Percentage of participants
Interval 42.62 to 78.8
|
48.39 Percentage of participants
Interval 30.79 to 65.98
|
SECONDARY outcome
Timeframe: From Day 1 up to 16 weeksPopulation: 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.
Time to the first adapted JIA ACR 30 response was measured in number of days since Day 1 (day of adapted JIA ACR 30 response - Day 1 + 1) in the OL Phase Part 1. Participants that did not achieve an adapted JIA ACR30 response defined as absence of fever due to sJIA \[temperature =\<38 degree Celsius/100.4 degree F in the preceding 7 days along with an improvement of at least 30% from baseline (Day 1 of study drug before first tofacitinib administration) in at least 3 of the 6 JIA core components, with worsening of \>=30 in no more than 1 of the remaining components, which in Part 1 (withdrew from the study) were censored at their last available response assessment in Part 1. 95% CI was based on the Brookmeyer and Crowley Method.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Time to First Adapted JIA ACR 30 Response: Open-label Phase Part 1
|
27.0 Days
Interval 15.0 to 29.0
|
—
|
SECONDARY outcome
Timeframe: 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 16Population: 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.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ) assessed on a VAS of 0 \[very well\] to 10 \[very poor\], ESR (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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
Part 1 Day 7
|
-5.64 Units on a scale
Standard Deviation 5.20
|
—
|
|
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
Part 1 Week 2
|
-8.57 Units on a scale
Standard Deviation 5.97
|
—
|
|
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
Part 1 Week 4
|
-11.95 Units on a scale
Standard Deviation 6.53
|
—
|
|
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
Part 1 Week 8
|
-15.09 Units on a scale
Standard Deviation 7.27
|
—
|
|
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
Part 1 Week 12
|
-15.77 Units on a scale
Standard Deviation 7.24
|
—
|
|
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
Part 1 Week 16
|
-14.08 Units on a scale
Standard Deviation 6.09
|
—
|
SECONDARY outcome
Timeframe: 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 16Population: 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.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was determined based on four components: physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 \[very well\] to 10 \[very poor\]), CRP (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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
Part 1 Day 7
|
-6.25 Units on a scale
Standard Deviation 5.53
|
—
|
|
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
Part 1 Week 2
|
-8.55 Units on a scale
Standard Deviation 6.10
|
—
|
|
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
Part 1 Week 4
|
-11.88 Units on a scale
Standard Deviation 7.28
|
—
|
|
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
Part 1 Week 8
|
-15.07 Units on a scale
Standard Deviation 8.46
|
—
|
|
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
Part 1 Week 12
|
-15.19 Units on a scale
Standard Deviation 7.73
|
—
|
|
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
Part 1 Week 16
|
-13.10 Units on a scale
Standard Deviation 6.37
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24Population: 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.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was determined based on four components: physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 \[very well\] to 10 \[very poor\]), ESR (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-17.05 Units on a scale
Standard Deviation 8.18
|
—
|
|
Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-17.13 Units on a scale
Standard Deviation 8.14
|
—
|
|
Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-18.17 Units on a scale
Standard Deviation 7.74
|
—
|
|
Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-18.89 Units on a scale
Standard Deviation 7.56
|
—
|
|
Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-21.14 Units on a scale
Standard Deviation 5.78
|
—
|
|
Change From Open-Label Baseline in JADAS-27 ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-22.17 Units on a scale
Standard Deviation 7.58
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20 and 24Population: 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.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was determined based on four components: physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 \[very well\] to 10 \[very poor\]), CRP (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-17.16 Units on a scale
Standard Deviation 8.87
|
—
|
|
Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-17.44 Units on a scale
Standard Deviation 8.03
|
—
|
|
Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-18.99 Units on a scale
Standard Deviation 7.67
|
—
|
|
Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-20.31 Units on a scale
Standard Deviation 6.41
|
—
|
|
Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-22.16 Units on a scale
Standard Deviation 7.05
|
—
|
|
Change From Open-Label Baseline in JADAS-27 CRP at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-25.61 Units on a scale
Standard Deviation 9.82
|
—
|
SECONDARY outcome
Timeframe: 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 52Population: 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.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ) (assessed on a VAS of 0 \[very well\] to 10 \[very poor\]), ESR (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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 Week 36
|
-1.52 Units on a scale
Standard Error 0.50
|
-1.26 Units on a scale
Standard Error 0.54
|
|
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 Week 40
|
-0.23 Units on a scale
Standard Error 0.91
|
-0.96 Units on a scale
Standard Error 0.96
|
|
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 Week 4
|
1.07 Units on a scale
Standard Error 0.84
|
1.08 Units on a scale
Standard Error 0.79
|
|
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 Week 8
|
1.75 Units on a scale
Standard Error 1.08
|
0.81 Units on a scale
Standard Error 1.06
|
|
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 Week 12
|
1.47 Units on a scale
Standard Error 1.46
|
1.71 Units on a scale
Standard Error 1.40
|
|
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 Week 16
|
0.43 Units on a scale
Standard Error 1.03
|
1.29 Units on a scale
Standard Error 1.04
|
|
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 Week 20
|
-1.04 Units on a scale
Standard Error 0.65
|
0.05 Units on a scale
Standard Error 0.69
|
|
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 Week 24
|
-0.49 Units on a scale
Standard Error 0.57
|
-0.79 Units on a scale
Standard Error 0.60
|
|
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 Week 28
|
2.58 Units on a scale
Standard Error 2.05
|
3.86 Units on a scale
Standard Error 2.25
|
|
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 Week 32
|
-0.21 Units on a scale
Standard Error 0.77
|
-0.68 Units on a scale
Standard Error 0.83
|
|
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 Week 44
|
-1.67 Units on a scale
Standard Error 0.75
|
-0.83 Units on a scale
Standard Error 0.79
|
|
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 Week 48
|
-2.29 Units on a scale
Standard Error 0.38
|
-2.06 Units on a scale
Standard Error 0.60
|
|
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 Week 52
|
-2.41 Units on a scale
Standard Error 0.60
|
-1.65 Units on a scale
Standard Error 1.07
|
SECONDARY outcome
Timeframe: 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 52Population: 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.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 \[very well\] to 10 \[very poor\]), CRP (value normalized to 0 to 10 scale) and number of joints with active disease (27 joint assessment ranging from 0 to 27). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
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 Week 4
|
1.62 Units on a scale
Standard Error 0.96
|
0.71 Units on a scale
Standard Error 0.90
|
|
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 Week 8
|
2.12 Units on a scale
Standard Error 0.95
|
0.01 Units on a scale
Standard Error 0.93
|
|
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 Week 12
|
1.78 Units on a scale
Standard Error 1.46
|
1.80 Units on a scale
Standard Error 1.40
|
|
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 Week 16
|
0.84 Units on a scale
Standard Error 1.09
|
1.95 Units on a scale
Standard Error 1.08
|
|
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 Week 20
|
-0.17 Units on a scale
Standard Error 0.84
|
0.36 Units on a scale
Standard Error 0.87
|
|
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 Week 24
|
1.58 Units on a scale
Standard Error 1.04
|
-0.26 Units on a scale
Standard Error 1.08
|
|
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 Week 28
|
2.64 Units on a scale
Standard Error 1.86
|
2.72 Units on a scale
Standard Error 2.04
|
|
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 Week 32
|
0.49 Units on a scale
Standard Error 0.99
|
1.18 Units on a scale
Standard Error 1.07
|
|
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 Week 36
|
-1.59 Units on a scale
Standard Error 0.50
|
-1.24 Units on a scale
Standard Error 0.53
|
|
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 Week 40
|
0.38 Units on a scale
Standard Error 1.15
|
0.41 Units on a scale
Standard Error 1.21
|
|
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 Week 44
|
-1.09 Units on a scale
Standard Error 0.99
|
1.50 Units on a scale
Standard Error 1.02
|
|
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 Week 48
|
-2.04 Units on a scale
Standard Error 0.51
|
-1.23 Units on a scale
Standard Error 0.76
|
|
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 Week 52
|
-2.31 Units on a scale
Standard Error 0.60
|
-1.85 Units on a scale
Standard Error 1.10
|
SECONDARY outcome
Timeframe: 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 16Population: 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 number of participants evaluable for specified rows.
The ACR defined a joint with active arthritis as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain on motion, or tenderness.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 7
|
-2.96 Joints
Standard Deviation 4.17
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 2
|
-4.21 Joints
Standard Deviation 5.31
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 4
|
-6.03 Joints
Standard Deviation 6.04
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 8
|
-7.80 Joints
Standard Deviation 9.25
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 12
|
-7.52 Joints
Standard Deviation 7.38
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 16
|
-6.38 Joints
Standard Deviation 7.87
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24Population: 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.
The ACR defined a joint with active arthritis as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain on motion, or tenderness.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-7.73 Joints
Standard Deviation 8.40
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-7.78 Joints
Standard Deviation 7.78
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-9.26 Joints
Standard Deviation 7.98
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-10.00 Joints
Standard Deviation 7.99
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-10.85 Joints
Standard Deviation 7.83
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-13.67 Joints
Standard Deviation 11.02
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16Population: 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 number of participants evaluable for specified rows.
Limitation of motion were assessed in the following joints: Temporomandibular, shoulder, elbow, wrist, metacarpophalangeal (MCP I-V), proximal interphalangeal (PIP I-V), distal interphalangeal (II-V), hip, knee, ankle, subtalar joints, intertarsal joints, metatarsophalangeal (MTP I-V), toe interphalangeal (I-V), cervical spine, thoracic spine, lumbar spine.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 7
|
-1.83 Joints
Standard Deviation 4.26
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 2
|
-2.06 Joints
Standard Deviation 4.70
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 4
|
-2.90 Joints
Standard Deviation 5.42
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 8
|
-4.36 Joints
Standard Deviation 8.59
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 12
|
-3.64 Joints
Standard Deviation 6.05
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 16
|
-2.33 Joints
Standard Deviation 3.48
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24Population: 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.
Limitation of motion were assessed in the following joints: Temporomandibular, shoulder, elbow, wrist, metacarpophalangeal (MCP I-V), proximal interphalangeal (PIP I-V), distal interphalangeal (II-V), hip, knee, ankle, subtalar joints, intertarsal joints, metatarsophalangeal (MTP I-V), Toe interphalangeal (I-V), cervical spine, thoracic spine, lumbar spine.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-4.26 Joints
Standard Deviation 6.75
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-3.90 Joints
Standard Deviation 6.08
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-5.81 Joints
Standard Deviation 7.48
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-5.74 Joints
Standard Deviation 7.13
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-5.92 Joints
Standard Deviation 9.32
|
—
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-15.67 Joints
Standard Deviation 11.02
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16Population: 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 number of participants evaluable for specified rows.
Physician global evaluation of disease activity was assessed on a 21-numbered circle VAS ranging from 0 to 10, where 0= no disease activity and 10= maximum disease activity. Where higher scores indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1
Part 1 Day 7
|
-1.18 units on a scale
Standard Deviation 1.36
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1
Part 1 Week 2
|
-1.82 units on a scale
Standard Deviation 1.68
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1
Part 1 Week 4
|
-2.62 units on a scale
Standard Deviation 1.75
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1
Part 1 Week 8
|
-3.40 units on a scale
Standard Deviation 2.01
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1
Part 1 Week 12
|
-3.66 units on a scale
Standard Deviation 2.08
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-label Phase Part 1
Part 1 Week 16
|
-3.50 units on a scale
Standard Deviation 1.93
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24Population: 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.
Physician global evaluation of disease activity was assessed on a 21-numbered circle VAS ranging from 0 to 10, where 0= no disease activity and 10= maximum disease activity. Where higher scores indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-4.54 Unit on a scale
Standard Deviation 2.10
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-4.53 Unit on a scale
Standard Deviation 1.74
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-4.65 Unit on a scale
Standard Deviation 1.57
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-4.89 Unit on a scale
Standard Deviation 1.77
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-5.62 Unit on a scale
Standard Deviation 1.21
|
—
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-6.17 Unit on a scale
Standard Deviation 1.44
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16Population: 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 number of participants evaluable for specified rows.
ESR was determined using an ESR testing kit.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 7
|
-11.00 Millimeter per hour
Standard Deviation 16.96
|
—
|
|
Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 2
|
-18.60 Millimeter per hour
Standard Deviation 19.78
|
—
|
|
Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 4
|
-24.70 Millimeter per hour
Standard Deviation 23.86
|
—
|
|
Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 8
|
-30.59 Millimeter per hour
Standard Deviation 23.12
|
—
|
|
Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 12
|
-31.74 Millimeter per hour
Standard Deviation 21.75
|
—
|
|
Change From Open-Label Baseline in ESR at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 16
|
-27.65 Millimeter per hour
Standard Deviation 28.84
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24Population: 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.
ESR was determined using an ESR testing kit.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-24.33 Millimeter per hour
Standard Deviation 6.03
|
—
|
|
Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-33.64 Millimeter per hour
Standard Deviation 28.16
|
—
|
|
Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-30.73 Millimeter per hour
Standard Deviation 27.11
|
—
|
|
Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-27.52 Millimeter per hour
Standard Deviation 28.13
|
—
|
|
Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-23.48 Millimeter per hour
Standard Deviation 24.70
|
—
|
|
Change From Open-Label Baseline in ESR at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-37.54 Millimeter per hour
Standard Deviation 20.93
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Days 3,7, Part 1 Weeks 2, 4, 8, 12, 16Population: 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 number of participants evaluable for specified rows.
The CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. For assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being by entering a number from 0 to 10 (in 0.5 increments), on a 21-circle VAS where '0= very well and 10=very poorly. Where higher scores indicated worse condition.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 3
|
-0.73 Units on a scale
Standard Deviation 1.53
|
—
|
|
Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 7
|
-1.36 Units on a scale
Standard Deviation 1.91
|
—
|
|
Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 2
|
-1.96 Units on a scale
Standard Deviation 1.89
|
—
|
|
Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 4
|
-2.65 Units on a scale
Standard Deviation 2.44
|
—
|
|
Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 8
|
-3.35 Units on a scale
Standard Deviation 2.38
|
—
|
|
Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 12
|
-3.45 Units on a scale
Standard Deviation 2.45
|
—
|
|
Change From Open-Label Baseline in CHAQ- Parental Evaluation of Overall Well-being at Part 1 Days 3, 7, Part 1 Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 16
|
-3.48 Units on a scale
Standard Deviation 2.78
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24Population: 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.
The CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. For assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being by entering a number from 0 to 10 (in 0.5 increments), on a 21-circle VAS where '0=Very Well and 10=Very Poorly. Where higher scores indicated worse condition.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in CHAQ - Parental Evaluation of Overall Well-being at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-4.09 Units on a scale
Standard Deviation 2.68
|
—
|
|
Change From Open-Label Baseline in CHAQ - Parental Evaluation of Overall Well-being at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-4.50 Units on a scale
Standard Deviation 2.88
|
—
|
|
Change From Open-Label Baseline in CHAQ - Parental Evaluation of Overall Well-being at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-4.73 Units on a scale
Standard Deviation 2.83
|
—
|
|
Change From Open-Label Baseline in CHAQ - Parental Evaluation of Overall Well-being at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-5.11 Units on a scale
Standard Deviation 2.50
|
—
|
|
Change From Open-Label Baseline in CHAQ - Parental Evaluation of Overall Well-being at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-5.65 Units on a scale
Standard Deviation 2.89
|
—
|
|
Change From Open-Label Baseline in CHAQ - Parental Evaluation of Overall Well-being at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-6.33 Units on a scale
Standard Deviation 2.31
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 1 Day 7, Weeks 2, 4, 8, 12, 16Population: 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 number of participants evaluable for specified rows.
CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall Well-being. CHAQ disability index consisted of 30 items in 8 areas: 1. dressing and grooming, 2. arising, 3. eating, 4. walking, 5. hygiene, 6. reach, 7. grip, and 8. activities distributed. Each item was rated on a 4-point scale, scored from 0 (no difficulty) to 3 (unable to do). The eight areas of the CHAQ were averaged to calculate the total disability index score which ranged from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher scores indicated more disability. A participant must have score for at least six of the eight areas, otherwise a CHAQ-DI score was not valid.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in CHAQ - Disability Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 7
|
-0.21 Units on a scale
Standard Deviation 0.35
|
—
|
|
Change From Open-Label Baseline in CHAQ - Disability Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 2
|
-0.38 Units on a scale
Standard Deviation 0.43
|
—
|
|
Change From Open-Label Baseline in CHAQ - Disability Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 4
|
-0.52 Units on a scale
Standard Deviation 0.56
|
—
|
|
Change From Open-Label Baseline in CHAQ - Disability Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 8
|
-0.59 Units on a scale
Standard Deviation 0.57
|
—
|
|
Change From Open-Label Baseline in CHAQ - Disability Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 12
|
-0.51 Units on a scale
Standard Deviation 0.56
|
—
|
|
Change From Open-Label Baseline in CHAQ - Disability Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 16
|
-0.74 Units on a scale
Standard Deviation 0.73
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), Part 2 Weeks 4, 8, 12, 16, 20, 24Population: 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 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 number of participants evaluable for specified rows.
CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. CHAQ disability index consisted of 30 items in 8 areas, 1. dressing and grooming, 2. arising, 3. eating, 4. walking, 5. hygiene, 6. reach, 7. grip, and 8. activities distributed. Each item was rated on a 4-point scale, scored from 0 (no difficulty) to-3 (unable to do). The eight areas of the CHAQ were averaged to calculate the total disability index score which ranged from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher scores indicated more disability. A participant must have score for at least six of the eight areas, otherwise a CHAQ-DI score was not valid.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-0.79 Units on a scale
Standard Deviation 0.63
|
—
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-0.78 Units on a scale
Standard Deviation 0.76
|
—
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-0.85 Units on a scale
Standard Deviation 0.80
|
—
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-0.67 Units on a scale
Standard Deviation 0.74
|
—
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-0.93 Units on a scale
Standard Deviation 0.77
|
—
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-0.96 Units on a scale
Standard Deviation 0.92
|
—
|
SECONDARY outcome
Timeframe: OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
The ACR defined a joint with active arthritis as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain on motion, or tenderness.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
-6.53 Joints
Standard Error 0.34
|
-7.39 Joints
Standard Error 0.32
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
-6.36 Joints
Standard Error 0.38
|
-7.69 Joints
Standard Error 0.38
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
-5.92 Joints
Standard Error 0.80
|
-7.36 Joints
Standard Error 0.76
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-7.34 Joints
Standard Error 0.25
|
-7.37 Joints
Standard Error 0.25
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-7.41 Joints
Standard Error 0.18
|
-7.51 Joints
Standard Error 0.20
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-7.33 Joints
Standard Error 0.13
|
-7.76 Joints
Standard Error 0.13
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
-6.36 Joints
Standard Error 0.59
|
-6.56 Joints
Standard Error 0.67
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-7.27 Joints
Standard Error 0.17
|
-7.76 Joints
Standard Error 0.19
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-7.43 Joints
Standard Error 0.14
|
-7.78 Joints
Standard Error 0.16
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-7.06 Joints
Standard Error 0.24
|
-7.58 Joints
Standard Error 0.27
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-7.39 Joints
Standard Error 0.33
|
-7.20 Joints
Standard Error 0.35
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-7.54 Joints
Standard Error 0.20
|
-7.75 Joints
Standard Error 0.25
|
|
Change From Open-Label Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-7.46 Joints
Standard Error 0.26
|
-7.51 Joints
Standard Error 0.28
|
SECONDARY outcome
Timeframe: DB Baseline (randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
The ACR defined a joint with active arthritis as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain on motion, or tenderness.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
0.38 Joints
Standard Error 0.26
|
0.09 Joints
Standard Error 0.24
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
0.78 Joints
Standard Error 0.38
|
-0.23 Joints
Standard Error 0.37
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
1.47 Joints
Standard Error 0.85
|
0.22 Joints
Standard Error 0.81
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
0.05 Joints
Standard Error 0.27
|
-0.05 Joints
Standard Error 0.27
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-0.15 Joints
Standard Error 0.15
|
-0.02 Joints
Standard Error 0.17
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-0.06 Joints
Standard Error 0.12
|
-0.39 Joints
Standard Error 0.13
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
0.71 Joints
Standard Error 0.70
|
0.88 Joints
Standard Error 0.84
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
0.01 Joints
Standard Error 0.18
|
-0.41 Joints
Standard Error 0.20
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-0.14 Joints
Standard Error 0.15
|
-0.47 Joints
Standard Error 0.17
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
0.31 Joints
Standard Error 0.25
|
-0.37 Joints
Standard Error 0.28
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-0.05 Joints
Standard Error 0.35
|
0.11 Joints
Standard Error 0.38
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-0.20 Joints
Standard Error 0.21
|
-0.56 Joints
Standard Error 0.27
|
|
Change From Double-Blind Baseline in Number of Joints With Active Arthritis at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-0.14 Joints
Standard Error 0.28
|
-0.38 Joints
Standard Error 0.34
|
SECONDARY outcome
Timeframe: OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
The parents were asked to provide responses to questions designed to assessed function in 8 distributed, among a total of 30 items. Each question was rated on a four-point scale, scored from 0-3. The question with the highest score determined the score for the functional area. If aids or devices were used or assistance was required, the minimum score for that was 2. Each question was rated 0 for no difficulty, 1 for some difficulties, 2 for much difficulties, and 3 for unable to do. The 8 areas of the CHAQ were averaged to calculated disability index which was ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction). A participant must have score for at least 6 of the 8 categories, otherwise a CHAQ-DI score was not valid.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
-0.81 Units on a scale
Standard Error 0.10
|
-1.03 Units on a scale
Standard Error 0.09
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
-0.93 Units on a scale
Standard Error 0.08
|
-1.02 Units on a scale
Standard Error 0.08
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
-0.99 Units on a scale
Standard Error 0.08
|
-1.04 Units on a scale
Standard Error 0.07
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-0.95 Units on a scale
Standard Error 0.09
|
-1.05 Units on a scale
Standard Error 0.09
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-1.02 Units on a scale
Standard Error 0.07
|
-1.21 Units on a scale
Standard Error 0.07
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-0.94 Units on a scale
Standard Error 0.08
|
-1.05 Units on a scale
Standard Error 0.08
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
-0.94 Units on a scale
Standard Error 0.08
|
-1.01 Units on a scale
Standard Error 0.09
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-0.96 Units on a scale
Standard Error 0.07
|
-1.11 Units on a scale
Standard Error 0.07
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-1.05 Units on a scale
Standard Error 0.08
|
-1.16 Units on a scale
Standard Error 0.09
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-1.07 Units on a scale
Standard Error 0.07
|
-1.22 Units on a scale
Standard Error 0.08
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-1.04 Units on a scale
Standard Error 0.09
|
-1.08 Units on a scale
Standard Error 0.09
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-1.01 Units on a scale
Standard Error 0.09
|
-1.10 Units on a scale
Standard Error 0.11
|
|
Change From Open-Label Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-1.04 Units on a scale
Standard Error 0.10
|
-1.13 Units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: DB Baseline (randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
The parents were asked to provide responses to questions designed to assessed function in 8 distributed, among a total of 30 items. Each question was rated on a four-point scale, scored from 0-3. The question with the highest score determined the score for the functional area. If aids or devices were used or assistance was required, the minimum score for that was 2. Each question was rated 0 for no difficulty, 1 for some difficulties, 2 for much difficulties, and 3 for unable to do. The 8 areas of the CHAQ were averaged to calculated disability index which was ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction). A participant must have score for at least 6 of the 8 categories, otherwise a CHAQ-DI score was not valid.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
0.04 Units on a scale
Standard Error 0.06
|
-0.02 Units on a scale
Standard Error 0.06
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
-0.03 Units on a scale
Standard Error 0.06
|
-0.01 Units on a scale
Standard Error 0.06
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
-0.06 Units on a scale
Standard Error 0.06
|
-0.05 Units on a scale
Standard Error 0.06
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-0.03 Units on a scale
Standard Error 0.07
|
-0.05 Units on a scale
Standard Error 0.07
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-0.08 Units on a scale
Standard Error 0.06
|
-0.23 Units on a scale
Standard Error 0.06
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
0.06 Units on a scale
Standard Error 0.08
|
-0.09 Units on a scale
Standard Error 0.08
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
0.05 Units on a scale
Standard Error 0.08
|
-0.04 Units on a scale
Standard Error 0.09
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
0.02 Units on a scale
Standard Error 0.07
|
-0.13 Units on a scale
Standard Error 0.07
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-0.03 Units on a scale
Standard Error 0.09
|
-0.19 Units on a scale
Standard Error 0.09
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-0.09 Units on a scale
Standard Error 0.07
|
-0.25 Units on a scale
Standard Error 0.07
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-0.06 Units on a scale
Standard Error 0.09
|
-0.10 Units on a scale
Standard Error 0.09
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-0.03 Units on a scale
Standard Error 0.09
|
-0.19 Units on a scale
Standard Error 0.12
|
|
Change From Double Blind Baseline in CHAQ-Disability Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-0.05 Units on a scale
Standard Error 0.10
|
-0.21 Units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: OL baseline (last value collected prior to day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
Limitation of motion were assessed in the following joints: Temporomandibular, shoulder, elbow, wrist, metacarpophalangeal (MCP I-V), proximal interphalangeal (PIP I-V), distal interphalangeal (II-V), hip, knee, ankle, subtalar joints, intertarsal joints, metatarsophalangeal (MTP I-V), toe interphalangeal (I-V), cervical spine, thoracic spine, lumbar spine.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
-2.47 Joints
Standard Error 0.43
|
-2.69 Joints
Standard Error 0.41
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
-2.31 Joints
Standard Error 0.45
|
-2.89 Joints
Standard Error 0.44
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
-2.09 Joints
Standard Error 0.71
|
-3.29 Joints
Standard Error 0.68
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-2.76 Joints
Standard Error 0.44
|
-2.70 Joints
Standard Error 0.43
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-2.79 Joints
Standard Error 0.19
|
-3.05 Joints
Standard Error 0.19
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-2.98 Joints
Standard Error 0.19
|
-3.07 Joints
Standard Error 0.19
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
-2.56 Joints
Standard Error 0.54
|
-2.10 Joints
Standard Error 0.56
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-2.89 Joints
Standard Error 0.18
|
-3.24 Joints
Standard Error 0.19
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-2.90 Joints
Standard Error 0.19
|
-3.21 Joints
Standard Error 0.21
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-2.96 Joints
Standard Error 0.24
|
-3.24 Joints
Standard Error 0.25
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-2.95 Joints
Standard Error 0.25
|
-3.24 Joints
Standard Error 0.26
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-3.03 Joints
Standard Error 0.27
|
-3.25 Joints
Standard Error 0.30
|
|
Change From Open-Label Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-2.75 Joints
Standard Error 0.36
|
-3.20 Joints
Standard Error 0.36
|
SECONDARY outcome
Timeframe: DB Baseline (values at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
Limitation of motion were assessed in the following joints: Temporomandibular, shoulder, elbow, wrist, metacarpophalangeal (MCP I-V), proximal interphalangeal (PIP I-V), distal interphalangeal (II-V), hip, knee, ankle, subtalar joints, intertarsal joints, metatarsophalangeal (MTP I-V), toe interphalangeal (I-V), cervical spine, thoracic spine, lumbar spine.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
0.45 Joints
Standard Error 0.42
|
0.06 Joints
Standard Error 0.42
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
0.48 Joints
Standard Error 0.44
|
-0.23 Joints
Standard Error 0.42
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-0.30 Joints
Standard Error 0.17
|
0.10 Joints
Standard Error 0.17
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-0.36 Joints
Standard Error 0.10
|
-0.19 Joints
Standard Error 0.11
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-0.53 Joints
Standard Error 0.10
|
-0.22 Joints
Standard Error 0.11
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
-0.05 Joints
Standard Error 0.40
|
1.05 Joints
Standard Error 0.46
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-0.41 Joints
Standard Error 0.10
|
-0.48 Joints
Standard Error 0.12
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-0.48 Joints
Standard Error 0.09
|
-0.46 Joints
Standard Error 0.10
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-0.48 Joints
Standard Error 0.15
|
-0.43 Joints
Standard Error 0.17
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-0.47 Joints
Standard Error 0.16
|
-0.43 Joints
Standard Error 0.17
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-0.50 Joints
Standard Error 0.20
|
-0.47 Joints
Standard Error 0.24
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-0.21 Joints
Standard Error 0.31
|
-0.42 Joints
Standard Error 0.33
|
|
Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
0.08 Joints
Standard Error 0.22
|
0.21 Joints
Standard Error 0.20
|
SECONDARY outcome
Timeframe: OL label Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
Physician global evaluation of disease activity was assessed on a 21-numbered circle VAS ranging from 0 to 10, where 0= no disease activity and 10=maximum disease activity, where higher scores indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
-4.22 Units on a scale
Standard Error 0.33
|
-5.22 Units on a scale
Standard Error 0.32
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
-4.23 Units on a scale
Standard Error 0.32
|
-5.55 Units on a scale
Standard Error 0.32
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
-4.89 Units on a scale
Standard Error 0.36
|
-5.42 Units on a scale
Standard Error 0.34
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-4.96 Units on a scale
Standard Error 0.32
|
-5.22 Units on a scale
Standard Error 0.32
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-5.32 Units on a scale
Standard Error 0.23
|
-5.64 Units on a scale
Standard Error 0.24
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-5.11 Units on a scale
Standard Error 0.22
|
-5.66 Units on a scale
Standard Error 0.23
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
-5.06 Units on a scale
Standard Error 0.37
|
-5.26 Units on a scale
Standard Error 0.40
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-5.08 Units on a scale
Standard Error 0.26
|
-5.71 Units on a scale
Standard Error 0.28
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-5.55 Units on a scale
Standard Error 0.16
|
-6.03 Units on a scale
Standard Error 0.18
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-5.23 Units on a scale
Standard Error 0.30
|
-5.88 Units on a scale
Standard Error 0.33
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-5.65 Units on a scale
Standard Error 0.21
|
-5.87 Units on a scale
Standard Error 0.22
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-5.87 Units on a scale
Standard Error 0.18
|
-6.14 Units on a scale
Standard Error 0.24
|
|
Change From Open-Label Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-5.86 Units on a scale
Standard Error 0.26
|
-5.97 Units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: DB label Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
Physician global evaluation of disease activity was assessed on a 21-numbered circle VAS ranging from 0 to 10, where 0= no disease activity and 10=maximum disease activity, where higher scores indicated more disease activity.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
0.16 Units on a scale
Standard Error 0.25
|
0.21 Units on a scale
Standard Error 0.24
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
0.45 Units on a scale
Standard Error 0.32
|
-0.14 Units on a scale
Standard Error 0.32
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
0.10 Units on a scale
Standard Error 0.40
|
-0.02 Units on a scale
Standard Error 0.39
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-0.11 Units on a scale
Standard Error 0.34
|
0.15 Units on a scale
Standard Error 0.34
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-0.51 Units on a scale
Standard Error 0.22
|
-0.35 Units on a scale
Standard Error 0.23
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-0.32 Units on a scale
Standard Error 0.22
|
-0.37 Units on a scale
Standard Error 0.22
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
0.09 Units on a scale
Standard Error 0.43
|
0.19 Units on a scale
Standard Error 0.47
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-0.11 Units on a scale
Standard Error 0.29
|
-0.42 Units on a scale
Standard Error 0.32
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-0.74 Units on a scale
Standard Error 0.17
|
-0.92 Units on a scale
Standard Error 0.18
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-0.17 Units on a scale
Standard Error 0.35
|
-0.53 Units on a scale
Standard Error 0.37
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-0.79 Units on a scale
Standard Error 0.21
|
-0.70 Units on a scale
Standard Error 0.22
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-1.03 Units on a scale
Standard Error 0.20
|
-1.09 Units on a scale
Standard Error 0.29
|
|
Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-1.00 Units on a scale
Standard Error 0.27
|
-0.92 Units on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: OL Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
ESR was determined using an ESR testing kit.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
-32.65 Millimeter per hour (mm/h)
Standard Error 4.72
|
-31.19 Millimeter per hour (mm/h)
Standard Error 4.49
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
-36.55 Millimeter per hour (mm/h)
Standard Error 4.38
|
-29.32 Millimeter per hour (mm/h)
Standard Error 4.29
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
-38.30 Millimeter per hour (mm/h)
Standard Error 4.50
|
-31.69 Millimeter per hour (mm/h)
Standard Error 4.35
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-39.52 Millimeter per hour (mm/h)
Standard Error 4.06
|
-31.02 Millimeter per hour (mm/h)
Standard Error 4.06
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-41.82 Millimeter per hour (mm/h)
Standard Error 2.22
|
-37.86 Millimeter per hour (mm/h)
Standard Error 2.32
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-42.25 Millimeter per hour (mm/h)
Standard Error 2.25
|
-40.81 Millimeter per hour (mm/h)
Standard Error 2.33
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
-37.83 Millimeter per hour (mm/h)
Standard Error 4.07
|
-33.51 Millimeter per hour (mm/h)
Standard Error 4.39
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-37.90 Millimeter per hour (mm/h)
Standard Error 3.67
|
-35.04 Millimeter per hour (mm/h)
Standard Error 3.91
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-39.36 Millimeter per hour (mm/h)
Standard Error 4.49
|
-28.41 Millimeter per hour (mm/h)
Standard Error 4.79
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-39.98 Millimeter per hour (mm/h)
Standard Error 4.12
|
-35.70 Millimeter per hour (mm/h)
Standard Error 4.31
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-47.16 Millimeter per hour (mm/h)
Standard Error 2.28
|
-38.84 Millimeter per hour (mm/h)
Standard Error 2.34
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-47.16 Millimeter per hour (mm/h)
Standard Error 2.29
|
-42.32 Millimeter per hour (mm/h)
Standard Error 2.72
|
|
Change From Open-Label Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-51.46 Millimeter per hour (mm/h)
Standard Error 1.08
|
-50.12 Millimeter per hour (mm/h)
Standard Error 1.24
|
SECONDARY outcome
Timeframe: DB Baseline (values at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
ESR was determined using an ESR testing kit.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-8.07 Millimeter/ hour (mm/h)
Standard Error 2.38
|
-2.14 Millimeter/ hour (mm/h)
Standard Error 2.96
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
3.35 Millimeter/ hour (mm/h)
Standard Error 3.71
|
9.41 Millimeter/ hour (mm/h)
Standard Error 3.50
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
1.94 Millimeter/ hour (mm/h)
Standard Error 3.97
|
12.39 Millimeter/ hour (mm/h)
Standard Error 3.93
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
1.42 Millimeter/ hour (mm/h)
Standard Error 4.53
|
12.28 Millimeter/ hour (mm/h)
Standard Error 4.40
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
0.45 Millimeter/ hour (mm/h)
Standard Error 4.32
|
13.59 Millimeter/ hour (mm/h)
Standard Error 4.35
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-2.04 Millimeter/ hour (mm/h)
Standard Error 2.17
|
4.98 Millimeter/ hour (mm/h)
Standard Error 2.31
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-2.51 Millimeter/ hour (mm/h)
Standard Error 2.14
|
2.01 Millimeter/ hour (mm/h)
Standard Error 2.28
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
1.73 Millimeter/ hour (mm/h)
Standard Error 4.19
|
11.08 Millimeter/ hour (mm/h)
Standard Error 4.55
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
2.01 Millimeter/ hour (mm/h)
Standard Error 3.78
|
8.77 Millimeter/ hour (mm/h)
Standard Error 4.05
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
0.88 Millimeter/ hour (mm/h)
Standard Error 4.83
|
16.37 Millimeter/ hour (mm/h)
Standard Error 5.17
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
0.34 Millimeter/ hour (mm/h)
Standard Error 4.25
|
8.33 Millimeter/ hour (mm/h)
Standard Error 4.47
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-7.05 Millimeter/ hour (mm/h)
Standard Error 2.34
|
3.44 Millimeter/ hour (mm/h)
Standard Error 2.41
|
|
Change From Double-Blind Baseline in ESR at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-11.70 Millimeter/ hour (mm/h)
Standard Error 1.39
|
-9.14 Millimeter/ hour (mm/h)
Standard Error 1.73
|
SECONDARY outcome
Timeframe: OL label Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
The CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. For assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being by entering a number from 0 to 10 (in 0.5 increments), on a 21-circle VAS where '0'= very well' and '10= very poorly, where higher scores indicated worse condition.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
-4.88 Units on a scale
Standard Error 0.29
|
-5.46 Units on a scale
Standard Error 0.29
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
-4.31 Units on a scale
Standard Error 0.37
|
-5.52 Units on a scale
Standard Error 0.34
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
-4.56 Units on a scale
Standard Error 0.36
|
-5.38 Units on a scale
Standard Error 0.35
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
-4.97 Units on a scale
Standard Error 0.34
|
-5.28 Units on a scale
Standard Error 0.33
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
-5.19 Units on a scale
Standard Error 0.32
|
-5.36 Units on a scale
Standard Error 0.34
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
-4.97 Units on a scale
Standard Error 0.29
|
-5.62 Units on a scale
Standard Error 0.30
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
-5.08 Units on a scale
Standard Error 0.44
|
-5.00 Units on a scale
Standard Error 0.48
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-5.63 Units on a scale
Standard Error 0.18
|
-5.55 Units on a scale
Standard Error 0.20
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-5.81 Units on a scale
Standard Error 0.18
|
-5.87 Units on a scale
Standard Error 0.21
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-5.98 Units on a scale
Standard Error 0.16
|
-5.94 Units on a scale
Standard Error 0.18
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-5.95 Units on a scale
Standard Error 0.21
|
-5.79 Units on a scale
Standard Error 0.23
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-5.45 Units on a scale
Standard Error 0.31
|
-5.30 Units on a scale
Standard Error 0.57
|
|
Change From Open-Label Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-6.06 Units on a scale
Standard Error 0.25
|
-5.98 Units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: DB Baseline (value at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: 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.
The CHAQ, derived from the adult health assessment questionnaire, comprised of two indices disability and discomfort, and parent global assessment of overall well-being. For assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being by entering a number from 0 to 10 (in 0.5 increments), on a 21-circle VAS where '0'= very well' and '10=very poorly.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-0.82 Units on a scale
Standard Error 0.26
|
-0.87 Units on a scale
Standard Error 0.38
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-0.16 Units on a scale
Standard Error 0.36
|
-0.37 Units on a scale
Standard Error 0.53
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
0.46 Units on a scale
Standard Error 0.28
|
-0.03 Units on a scale
Standard Error 0.27
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
0.60 Units on a scale
Standard Error 0.38
|
0.12 Units on a scale
Standard Error 0.38
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
0.25 Units on a scale
Standard Error 0.36
|
0.22 Units on a scale
Standard Error 0.35
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
0.27 Units on a scale
Standard Error 0.31
|
0.04 Units on a scale
Standard Error 0.31
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
0.14 Units on a scale
Standard Error 0.37
|
0.05 Units on a scale
Standard Error 0.38
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
0.14 Units on a scale
Standard Error 0.29
|
-0.14 Units on a scale
Standard Error 0.30
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
0.54 Units on a scale
Standard Error 0.52
|
0.52 Units on a scale
Standard Error 0.56
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-0.32 Units on a scale
Standard Error 0.24
|
-0.34 Units on a scale
Standard Error 0.25
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-0.56 Units on a scale
Standard Error 0.21
|
-0.63 Units on a scale
Standard Error 0.22
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-0.72 Units on a scale
Standard Error 0.19
|
-0.78 Units on a scale
Standard Error 0.20
|
|
Change From Double-Blind Baseline in CHAQ -Parental Evaluation of Overall Well-being at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-0.65 Units on a scale
Standard Error 0.24
|
-0.54 Units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: OL Baseline up to 16 weeksPopulation: 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 number of participants evaluable for specified rows.
The CHQ is a validated general pediatric quality of life instrument. The CHQ assessed for 14 physical and psychosocial domains: general health perceptions (global health perception), physical functioning, role/social physical functioning, bodily pain, role/social emotional functioning, role/social behavioral functioning, parent/legal guardian/adult caregiver impact-time, parent/legal guardian/adult caregiver impact-emotional, self-esteem, mental health, behavior, family activities, family cohesion, and change in health. The response options for the CHQ are ordinal scales that vary by the item. Each item consisted of 4-6 response options. The CHQ score was determined based on the parent/legal guardian/adult caregiver's questionnaire responses. Range on subscales and the overall scale is 0 to 100, where 0 is the worst possible health state and 100 the best possible health state.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Family Activities Subscale Standardized Score
|
74.03 Units on a scale
Standard Deviation 22.41
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Family Cohesion Subscale Standardized Score
|
8.10 Units on a scale
Standard Deviation 22.67
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Global Health Subscale Standardized Score
|
26.12 Units on a scale
Standard Deviation 29.10
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Physical Functioning Subscale Standardized Score
|
28.95 Units on a scale
Standard Deviation 33.79
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Social Limitations: Emotional Subscale Standardized Score
|
27.51 Units on a scale
Standard Deviation 38.39
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Social Limitations: Physical Subscale Standardized Score
|
31.15 Units on a scale
Standard Deviation 42.96
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Bodily Pain Subscale Standardized Score
|
32.00 Units on a scale
Standard Deviation 26.67
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Behavior Subscale Standardized Score
|
10.98 Units on a scale
Standard Deviation 17.14
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Global Behavior Subscale Standardized Score
|
11.18 Units on a scale
Standard Deviation 27.75
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Mental Health Subscale Standardized Score
|
13.33 Units on a scale
Standard Deviation 20.20
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Self Esteem Subscale Standardized Score
|
7.68 Units on a scale
Standard Deviation 21.29
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
General Health Subscale Standardized Score
|
8.37 Units on a scale
Standard Deviation 13.93
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Change in Health Subscale Score
|
1.28 Units on a scale
Standard Deviation 1.10
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Emotional Impact on Parent Subscale Standardized Score
|
12.75 Units on a scale
Standard Deviation 26.43
|
—
|
|
Change From Open-Label Baseline in Child Health Questionnaire (CHQ) Responses at End of Open-Label Phase Part 1
Time Impact on Parent Subscale Standardized Score
|
14.81 Units on a scale
Standard Deviation 28.62
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) up to 24 weeksPopulation: 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.
The CHQ is a validated general pediatric quality of life instrument. The CHQ assessed for 14 physical and psychosocial domains: general health perceptions (global health perception), physical functioning, role/social physical functioning, bodily pain, role/social emotional functioning, role/social behavioral functioning, parent/legal guardian/adult caregiver impact-time, parent/legal guardian/adult caregiver impact-emotional, self-esteem, mental health, behavior, family activities, family cohesion, and change in health. The response options for the CHQ are ordinal scales that vary by the item. Each item consisted of 4-6 response options. The CHQ score was determined based on the parent/legal guardian/adult caregiver's questionnaire responses. Range on subscales and the overall scale is 0 to 100, where 0 is the worst possible health state and 100 the best possible health state.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=29 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Mental Health Standardized Score
|
18.04 Units on a scale
Standard Deviation 21.01
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Global Health Standardized Score
|
25.52 Units on a scale
Standard Deviation 35.46
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Physical Functioning Standardized Score
|
33.33 Units on a scale
Standard Deviation 31.29
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Social Limitations: Emotional Score
|
28.17 Units on a scale
Standard Deviation 43.98
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Social Limitations: Physical Score
|
38.10 Units on a scale
Standard Deviation 42.28
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Bodily Pain Standardized Score
|
34.48 Units on a scale
Standard Deviation 26.80
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Behavior Standardized Score
|
13.02 Units on a scale
Standard Deviation 21.14
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Global Behavior Standardized Score
|
10.00 Units on a scale
Standard Deviation 34.10
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Self Esteem Standardized Score
|
8.30 Units on a scale
Standard Deviation 34.18
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
General Health Standardized Score
|
8.18 Units on a scale
Standard Deviation 15.94
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Change in Health Subscale Score
|
1.54 Units on a scale
Standard Deviation 1.23
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Emotional Impact on Parent Standardized Score
|
22.92 Units on a scale
Standard Deviation 36.33
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Time Impact on Parent Standardized Score
|
34.57 Units on a scale
Standard Deviation 25.66
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Family Activities Standardized Score
|
27.62 Units on a scale
Standard Deviation 25.87
|
—
|
|
Change From Open-Label Baseline in CHQ Responses at End of Open-Label Phase Part 2
Family Cohesion Standardized Score
|
10.00 Units on a scale
Standard Deviation 23.25
|
—
|
SECONDARY outcome
Timeframe: DB Baseline (values at randomization), DB Weeks 24, 48Population: 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.
The CHQ is a validated general pediatric quality of life instrument. The CHQ assessed for 14 physical and psychosocial domains: general health perceptions (global health perception), physical functioning, role/social physical functioning, bodily pain, role/social emotional functioning, role/social behavioral functioning, parent/legal guardian/adult caregiver impact-time, parent/legal guardian/adult caregiver impact-emotional, self-esteem, mental health, behavior, family activities, family cohesion, and change in health. The response options for the CHQ are ordinal scales that vary by the item. Each item consisted of 4-6 response options. The CHQ score was determined based on the parent/legal guardian/adult caregiver's questionnaire responses. Range on subscales and the overall scale is 0 to 100, where 0 is the worst possible health state and 100 the best possible health state.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=17 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=15 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Global Health Subscale Standardized Score: DB Week 24
|
4.02 Units on a scale
Standard Error 4.71
|
-1.98 Units on a scale
Standard Error 5.02
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Physical Functioning Subscale Standardized Score: DB Week 48
|
5.24 Units on a scale
Standard Error 9.13
|
2.93 Units on a scale
Standard Error 14.02
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Global Health Subscale Standardized Score: DB Week 48
|
4.09 Units on a scale
Standard Error 3.93
|
1.24 Units on a scale
Standard Error 4.49
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Physical Functioning Subscale Standardized Score: DB Week 24
|
2.51 Units on a scale
Standard Error 3.86
|
6.70 Units on a scale
Standard Error 3.99
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Social Limitations: Emotional Subscale Standardized Score: DB Week 24
|
2.62 Units on a scale
Standard Error 4.00
|
8.09 Units on a scale
Standard Error 4.18
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Social Limitations: Emotional Subscale Standardized Score: DB Week 48
|
6.09 Units on a scale
Standard Error 7.69
|
-0.73 Units on a scale
Standard Error 10.33
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Social Limitations: Physical Subscale Standardized Score: DB Week 24
|
2.75 Units on a scale
Standard Error 4.27
|
8.98 Units on a scale
Standard Error 4.54
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Social Limitations: Physical Subscale Standardized Score: DB Week 48
|
3.45 Units on a scale
Standard Error 13.33
|
-7.64 Units on a scale
Standard Error 20.06
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24
|
-1.61 Units on a scale
Standard Error 4.19
|
-0.16 Units on a scale
Standard Error 4.41
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48
|
-2.72 Units on a scale
Standard Error 10.19
|
-19.92 Units on a scale
Standard Error 13.98
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Behavior Subscale Standardized Score: DB Week 24
|
2.33 Units on a scale
Standard Error 2.68
|
7.48 Units on a scale
Standard Error 2.87
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Behavior Subscale Standardized Score: DB Week 48
|
-4.50 Units on a scale
Standard Error 4.97
|
10.53 Units on a scale
Standard Error 5.35
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Global Behavior Subscale Standardized Score: DB Week 24
|
4.17 Units on a scale
Standard Error 3.89
|
9.48 Units on a scale
Standard Error 4.13
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Global Behavior Subscale Standardized Score: DB Week 48
|
5.90 Units on a scale
Standard Error 4.00
|
13.14 Units on a scale
Standard Error 4.54
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Mental Health Subscale Standardized Score: DB Week 24
|
6.59 Units on a scale
Standard Error 3.56
|
2.14 Units on a scale
Standard Error 3.78
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Mental Health Subscale Standardized Score: DB Week 48
|
0.79 Units on a scale
Standard Error 4.98
|
8.26 Units on a scale
Standard Error 5.71
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Self Esteem Subscale Standardized Score: DB Week 24
|
6.68 Units on a scale
Standard Error 3.05
|
6.69 Units on a scale
Standard Error 3.24
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Self Esteem Subscale Standardized Score: DB Week 48
|
3.05 Units on a scale
Standard Error 7.24
|
10.64 Units on a scale
Standard Error 8.04
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-General Health Subscale Standardized Score: DB Week 24
|
5.02 Units on a scale
Standard Error 3.21
|
0.03 Units on a scale
Standard Error 3.42
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-General Health Subscale Standardized Score: DB Week 48
|
9.59 Units on a scale
Standard Error 5.20
|
10.60 Units on a scale
Standard Error 5.92
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Change in Health Subscale Score: DB Week 24
|
0.45 Units on a scale
Standard Error 0.12
|
0.48 Units on a scale
Standard Error 0.13
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Change in Health Subscale Score: DB Week 48
|
0.64 Units on a scale
Standard Error 0.32
|
0.16 Units on a scale
Standard Error 0.35
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Emotion al Impact on Parent Subscale Standardized Score: DB Week 24
|
15.00 Units on a scale
Standard Error 4.28
|
12.75 Units on a scale
Standard Error 4.53
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Emotion al Impact on Parent Subscale Standardized Score: DB Week 48
|
7.15 Units on a scale
Standard Error 10.25
|
32.22 Units on a scale
Standard Error 11.79
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Time Impact on Parent Subscale Standardized Score: DB Week 24
|
7.53 Units on a scale
Standard Error 5.10
|
5.66 Units on a scale
Standard Error 5.25
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Time Impact on Parent Subscale Standardized Score: DB Week 48
|
11.60 Units on a scale
Standard Error 8.94
|
20.79 Units on a scale
Standard Error 14.05
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Family Activities Subscale Standardized Score: DB Week 24
|
5.71 Units on a scale
Standard Error 2.96
|
9.68 Units on a scale
Standard Error 3.13
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Family Activities Subscale Standardized Score: DB Week 48
|
6.65 Units on a scale
Standard Error 5.73
|
15.95 Units on a scale
Standard Error 7.16
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Family Cohesion Subscale Standardized Score: DB Week 24
|
2.84 Units on a scale
Standard Error 3.71
|
6.36 Units on a scale
Standard Error 3.96
|
|
Change From Double-Blind Baseline in CHQ Responses at DB Weeks 24, 48: Double-Blind Phase
CHQ01-Family Cohesion Subscale Standardized Score: DB Week 48
|
-12.24 Units on a scale
Standard Error 13.08
|
8.18 Units on a scale
Standard Error 15.58
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) Part 1 Day 7, Weeks 2, 4, 8, 12, 16Population: OLPT1 consisted of all participants who were enrolled into the OL part 1 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 number of participants evaluable for specified rows.
For the assessment of discomfort, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall pain the participant had due to illness by entering a number from 0 to 10 (in 0.5 increments), with '0' as 'no pain' and '10' as 'very severe pain' on a 21-circle VAS, where higher scores indicated more severe pain.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-Label Baseline in CHAQ-Discomfort Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 7
|
-1.20 Units on a scale
Standard Deviation 1.77
|
—
|
|
Change From Open-Label Baseline in CHAQ-Discomfort Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 2
|
-1.87 Units on a scale
Standard Deviation 2.07
|
—
|
|
Change From Open-Label Baseline in CHAQ-Discomfort Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 4
|
-2.57 Units on a scale
Standard Deviation 2.14
|
—
|
|
Change From Open-Label Baseline in CHAQ-Discomfort Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 8
|
-3.30 Units on a scale
Standard Deviation 2.45
|
—
|
|
Change From Open-Label Baseline in CHAQ-Discomfort Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 12
|
-3.57 Units on a scale
Standard Deviation 2.50
|
—
|
|
Change From Open-Label Baseline in CHAQ-Discomfort Index at Part 1 Day 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 16
|
-3.69 Units on a scale
Standard Deviation 2.28
|
—
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) Part 2 Weeks 4, 8, 12, 16, 20, 24Population: OLPT2 consisted of all participants who were enrolled into the OL part 2 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.
For the assessment of discomfort, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall pain the participant had due to illness by entering a number from 0 to 10 (in 0.5 increments), with '0' as 'no pain' and '10' as 'very severe pain' on a 21-circle VAS, where higher scores indicated more pain.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
-4.23 Units on a scale
Standard Deviation 3.14
|
—
|
|
Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
-4.38 Units on a scale
Standard Deviation 2.95
|
—
|
|
Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
-4.42 Units on a scale
Standard Deviation 3.26
|
—
|
|
Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
-4.48 Units on a scale
Standard Deviation 2.88
|
—
|
|
Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
-5.15 Units on a scale
Standard Deviation 3.52
|
—
|
|
Change From Open-label Baseline in CHAQ-Discomfort Index at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
-6.00 Units on a scale
Standard Deviation 1.73
|
—
|
SECONDARY outcome
Timeframe: DB Baseline (value at randomization), DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
For the assessment of discomfort, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall pain the participant had due to illness by entering a number from 0 to 10 (in 0.5 increments), with '0' as 'no pain' and '10' as 'very severe pain' on a 21-circle VAS, where higher scores indicated more severe pain.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
0.13 Units on a scale
Standard Error 0.28
|
0.37 Units on a scale
Standard Error 0.26
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
0.56 Units on a scale
Standard Error 0.36
|
0.02 Units on a scale
Standard Error 0.35
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
0.04 Units on a scale
Standard Error 0.34
|
0.09 Units on a scale
Standard Error 0.32
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
0.44 Units on a scale
Standard Error 0.36
|
-0.11 Units on a scale
Standard Error 0.35
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
0.09 Units on a scale
Standard Error 0.40
|
-0.14 Units on a scale
Standard Error 0.42
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
0.07 Units on a scale
Standard Error 0.27
|
-0.25 Units on a scale
Standard Error 0.28
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
-0.03 Units on a scale
Standard Error 0.47
|
0.39 Units on a scale
Standard Error 0.51
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
-0.31 Units on a scale
Standard Error 0.39
|
0.01 Units on a scale
Standard Error 0.42
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
-0.55 Units on a scale
Standard Error 0.34
|
-0.24 Units on a scale
Standard Error 0.37
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
-0.76 Units on a scale
Standard Error 0.20
|
-0.83 Units on a scale
Standard Error 0.21
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
-1.09 Units on a scale
Standard Error 0.23
|
-0.79 Units on a scale
Standard Error 0.24
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
-0.19 Units on a scale
Standard Error 0.49
|
-0.43 Units on a scale
Standard Error 0.79
|
|
Change From Double-Blind Baseline in CHAQ-Discomfort Index at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
-0.85 Units on a scale
Standard Error 0.21
|
-0.76 Units on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Part 1 Day 7, Part 1 Weeks 2, 4, 8, 12 and 16Population: OLPT1 consisted of all participants who were enrolled into the OL part 1 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": participants evaluable for specified time points and used for calculating percentages.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (\>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of: \<= 3.8. For participants with oligoarthritis (\<= 4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of \<=2.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Day 7
|
3.09 Percentage of participants
Interval 0.0 to 6.54
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 2
|
5.21 Percentage of participants
Interval 0.76 to 9.65
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 4
|
6.19 Percentage of participants
Interval 1.39 to 10.98
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 8
|
13.75 Percentage of participants
Interval 6.2 to 21.3
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 12
|
13.64 Percentage of participants
Interval 3.5 to 23.78
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 16
|
25.00 Percentage of participants
Interval 7.68 to 42.32
|
—
|
SECONDARY outcome
Timeframe: Part 1 Day 7, Weeks 2, 4, 8, 12 and 16Population: OLPT1 consisted of all participants who were enrolled into the OL part 1 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": participants evaluable for specified time points and used for calculating percentages.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (\>4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of: \<= 3.8. For participants with oligoarthritis (\<= 4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of \<=2.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Day 7
|
1.02 Percentage of participants
Interval 0.0 to 3.01
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 2
|
4.08 Percentage of participants
Interval 0.16 to 8.0
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 4
|
7.22 Percentage of participants
Interval 2.07 to 12.37
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 8
|
14.81 Percentage of participants
Interval 7.08 to 22.55
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 12
|
15.91 Percentage of participants
Interval 5.1 to 26.72
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 16
|
20.83 Percentage of participants
Interval 4.59 to 37.08
|
—
|
SECONDARY outcome
Timeframe: Part 2 Weeks 4, 8, 12, 16, 20, 24Population: OLPT2 consisted of all participants who were enrolled into the OL part 2 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": participants evaluable for specified time points and used for calculating percentages.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (\>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of: \<= 3.8. For participants with oligoarthritis (\<= 4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of \<=2.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
36.00 Percentage of participants
Interval 22.7 to 49.3
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
30.00 Percentage of participants
Interval 15.8 to 44.2
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
32.26 Percentage of participants
Interval 15.8 to 48.71
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
36.36 Percentage of participants
Interval 16.26 to 56.47
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
53.85 Percentage of participants
Interval 26.75 to 80.95
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
33.33 Percentage of participants
Interval 0.0 to 86.68
|
—
|
SECONDARY outcome
Timeframe: Part 2 Weeks 4, 8, 12, 16, 20, 24Population: OLPT2 consisted of all participants who were enrolled into the OL part 2 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": participants evaluable for specified time points and used for calculating percentages.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (\>4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of: \<= 3.8. For participants with oligoarthritis (\<= 4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of \<=2.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
32.00 Percentage of participants
Interval 19.07 to 44.93
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
27.50 Percentage of participants
Interval 13.66 to 41.34
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
29.03 Percentage of participants
Interval 13.05 to 45.01
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
34.78 Percentage of participants
Interval 15.32 to 54.25
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
53.85 Percentage of participants
Interval 26.75 to 80.95
|
—
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
33.33 Percentage of participants
Interval 0.0 to 86.68
|
—
|
SECONDARY outcome
Timeframe: Part 1 Day 7, Weeks 2, 4, 8, 12 and 16Population: OLPT1 consisted of all participants who were enrolled into the OL part 1 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": participants evaluable for specified time points and used for calculating percentages.
JADAS-27 is a validated composite disease activity measure for JIA. Score were determined based on four components:Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores:more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27,where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57,where higher scores:more disease activity.Inactive disease activity based on JADAS-27 CRP score was defined as: For participants with polyarthritis (\>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of:\<=1.For participants with oligoarthritis (\<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of \<=1.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Day 7
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 2
|
3.13 Percentage of Participants
Interval 0.0 to 6.61
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 4
|
3.09 Percentage of Participants
Interval 0.0 to 6.54
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 8
|
5.00 Percentage of Participants
Interval 0.22 to 9.78
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 12
|
4.55 Percentage of Participants
Interval 0.0 to 10.7
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-label Phase Part 1
Part 1 Week 16
|
4.17 Percentage of Participants
Interval 0.0 to 12.16
|
—
|
SECONDARY outcome
Timeframe: Part 1 Day 7, Weeks 2, 4, 8, 12 and 16Population: OLPT1 consisted of all participants who were enrolled into the OL part 1 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": participants evaluable for specified time points and used for calculating percentages.
JADAS-27 is a validated composite disease activity measure for JIA. Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity);parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores:more inflammation and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores:more disease activity. Inactive Disease activity based on JADAS-27 ESR score was defined as for participants with polyarthritis(\>4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of:\<=1. For participants with oligoarthritis (\<=4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of \<=1.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Day 7
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 2
|
2.04 Percentage of Participants
Interval 0.0 to 4.84
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 4
|
1.03 Percentage of Participants
Interval 0.0 to 3.04
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 8
|
3.70 Percentage of Participants
Interval 0.0 to 7.82
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 12
|
6.82 Percentage of Participants
Interval 0.0 to 14.27
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 1 Day 7, Weeks 2, 4, 8, 12 and 16: Open-Label Phase Part 1
Part 1 Week 16
|
4.17 Percentage of Participants
Interval 0.0 to 12.16
|
—
|
SECONDARY outcome
Timeframe: Part 2 Weeks 4, 8, 12, 16, 20, 24Population: OLPT2 consisted of all participants who were enrolled into the OL part 2 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": participants evaluable for specified time points and used for calculating percentages.
JADAS-27 is a validated composite disease activity measure for JIA.Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity);parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores: more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27,where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57,where higher scores: more disease activity.Inactive disease activity based on JADAS-27 CRP score was defined as: For participants with polyarthritis (\>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of:\<=1.For participants with oligoarthritis (\<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of \<=1.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
16.00 Percentage of Participants
Interval 5.84 to 26.16
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
20.00 Percentage of Participants
Interval 7.6 to 32.4
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
9.68 Percentage of Participants
Interval 0.0 to 20.09
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
18.18 Percentage of Participants
Interval 2.06 to 34.3
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
38.46 Percentage of Participants
Interval 12.01 to 64.91
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
33.33 Percentage of Participants
Interval 0.0 to 86.68
|
—
|
SECONDARY outcome
Timeframe: Part 2 Weeks 4, 8, 12, 16, 20, 24Population: OLPT2 consisted of all participants who were enrolled into the OL part 2 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": participants evaluable for specified time points and used for calculating percentages.
JADAS-27 is a validated composite disease activity measure for JIA. Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity);parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores:more inflammation and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores:more disease activity. Inactive Disease activity based on JADAS-27 ESR score was defined as for participants with polyarthritis(\>4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of:\<=1. For participants with oligoarthritis (\<=4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of \<=1.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
16.00 Percentage of Participants
Interval 5.84 to 26.16
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
17.50 Percentage of Participants
Interval 5.72 to 29.28
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
9.68 Percentage of Participants
Interval 0.0 to 20.09
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
17.39 Percentage of Participants
Interval 1.9 to 32.88
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
46.15 Percentage of Participants
Interval 19.05 to 73.25
|
—
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
33.33 Percentage of Participants
Interval 0.0 to 86.68
|
—
|
SECONDARY outcome
Timeframe: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), CRP (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (\>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of: \<= 3.8. For participants with oligoarthritis (\<= 4 active joints) minimal disease activity was defined as a JADAS-27 CRP score of \<=2.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
21.43 Percentage of Participants
|
51.61 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
25.00 Percentage of Participants
|
48.39 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
32.14 Percentage of Participants
|
32.26 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
35.71 Percentage of Participants
|
29.03 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
35.71 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
35.71 Percentage of Participants
|
35.48 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
35.71 Percentage of Participants
|
32.26 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
28.57 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
39.29 Percentage of Participants
|
35.48 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
39.29 Percentage of Participants
|
29.03 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
46.43 Percentage of Participants
|
25.81 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
46.43 Percentage of Participants
|
25.81 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
46.43 Percentage of Participants
|
29.03 Percentage of Participants
|
SECONDARY outcome
Timeframe: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score were determined based on four components: Physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores indicated more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores indicated more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores indicated more disease activity. For participants with polyarthritis (\>4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of: \<= 3.8. For participants with oligoarthritis (\<= 4 active joints) minimal disease activity was defined as a JADAS-27 ESR score of \<=2.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
25.00 Percentage of Participants
|
51.61 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
25.00 Percentage of Participants
|
45.16 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
32.14 Percentage of Participants
|
41.94 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
35.71 Percentage of Participants
|
35.48 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
39.29 Percentage of Participants
|
29.03 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
35.71 Percentage of Participants
|
38.71 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
35.71 Percentage of Participants
|
38.71 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
28.57 Percentage of Participants
|
35.48 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
39.29 Percentage of Participants
|
35.48 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
39.29 Percentage of Participants
|
32.26 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
50.00 Percentage of Participants
|
32.26 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
50.00 Percentage of Participants
|
35.48 Percentage of Participants
|
|
Percentage of Participants With Minimum Disease Activity Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
50.00 Percentage of Participants
|
32.26 Percentage of Participants
|
SECONDARY outcome
Timeframe: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
JADAS-27 is a validated composite disease activity measure for JIA.Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity); parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor),CRP (value normalized to 0 to 10 scale, where higher scores:more inflammation) and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores:more disease activity).The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores:more disease activity. Inactive disease activity based on JADAS-27 CRP score was defined as: For participants with polyarthritis (\>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of:\<=1.For participants with oligoarthritis (\<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score of \<=1.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 4
|
10.71 Percentage of Participants
|
25.81 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 8
|
7.14 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 12
|
7.14 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 16
|
14.29 Percentage of Participants
|
9.68 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 20
|
14.29 Percentage of Participants
|
9.68 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 24
|
7.14 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 28
|
10.71 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 32
|
14.29 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 36
|
10.71 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 40
|
14.29 Percentage of Participants
|
25.81 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 44
|
14.29 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 48
|
10.71 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 CRP Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-blind Phase
DB Week 52
|
14.29 Percentage of Participants
|
19.35 Percentage of Participants
|
SECONDARY outcome
Timeframe: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
JADAS-27 is a validated composite disease activity measure for JIA. Score were determined based on four components:physician global assessment of disease activity assessed on a VAS of 0 (no activity) to 10 (maximum activity);parent/legal guardian global assessment of well-being (from the CHAQ assessed on a VAS of 0 (very well) to 10 (very poor), ESR (value normalized to 0 to 10 scale, where higher scores:more inflammation and number of joints with active disease (27 joint assessment ranging from 0 to 27, where higher scores:more disease activity). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57, where higher scores:more disease activity. Inactive Disease activity based on JADAS-27 ESR score was defined as for participants with polyarthritis(\>4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of:\<=1. For participants with oligoarthritis (\<=4 active joints) inactive disease activity was defined as a JADAS-27 ESR score of \<=1.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
17.86 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
14.29 Percentage of Participants
|
12.90 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
10.71 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
10.71 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
14.29 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
10.71 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
14.29 Percentage of Participants
|
25.81 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
14.29 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
14.29 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
14.29 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
7.14 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
14.29 Percentage of Participants
|
29.03 Percentage of Participants
|
|
Percentage of Participants With Inactive Disease Status Calculated From JADAS-27 ESR Score at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
14.29 Percentage of Participants
|
22.58 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (last value collected prior to Day 1 of tofacitinib administration in OL phase) Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16Population: OLPT1 consisted of all participants who were enrolled into the OL part 1 and received at least one dose of investigational product in part 1. Here "Number analyzed" signifies participants evaluable for specified time points and used for calculating percentages.
The ACR clinical inactive disease was defined as follows: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA; no active uveitis; normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA; physician global assessment of disease activity score of 'best possible' on the 21-numbered circle VAS scale used (VAS from 0 to 10), higher scores indicated more disease activity; duration of morning stiffness of \<=15 minutes. 95% CI was based on normal approximation.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=100 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Baseline
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 3
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Day 7
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 2
|
2.02 Percentage of Participants
Interval 0.0 to 4.79
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 4
|
3.09 Percentage of Participants
Interval 0.0 to 6.54
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 8
|
4.82 Percentage of Participants
Interval 0.21 to 9.43
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 12
|
4.55 Percentage of Participants
Interval 0.0 to 10.7
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 1 Days 3, 7, Weeks 2, 4, 8, 12, 16: Open-Label Phase Part 1
Part 1 Week 16
|
4.17 Percentage of Participants
Interval 0.0 to 12.16
|
—
|
SECONDARY outcome
Timeframe: Part 2 Weeks 4, 8, 12, 16, 20, 24Population: OLPT2 consisted of all participants who were enrolled into the OL part 2 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
The ACR clinical inactive disease was defined as follows: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA; no active uveitis; normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA; physician global assessment of disease activity score of 'best possible' on the 21-numbered circle VAS scale used (VAS from 0 to 10), higher scores indicated more disease activity; duration of morning stiffness of \<=15 minutes. 95% CI was based on normal approximation. 95% CI was based on normal approximation.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=54 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 4
|
14.00 Percentage of participants
Interval 4.38 to 23.62
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 8
|
10.26 Percentage of participants
Interval 0.73 to 19.78
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 12
|
6.45 Percentage of participants
Interval 0.0 to 15.1
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 16
|
13.04 Percentage of participants
Interval 0.0 to 26.81
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 20
|
15.38 Percentage of participants
Interval 0.0 to 35.0
|
—
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at Part 2 Weeks 4, 8, 12, 16, 20, 24: Open-Label Phase Part 2
Part 2 Week 24
|
33.33 Percentage of participants
Interval 0.0 to 86.68
|
—
|
SECONDARY outcome
Timeframe: DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: DBFAS consisted of all randomized participants who received at least one dose of investigational product in the DB phase.
The ACR clinical inactive disease was defined as follows: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA; no active uveitis; normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA; physician global assessment of disease activity score of 'best possible' on the 21-numbered circle VAS scale used (VAS from 0 to 10), higher scores indicated more disease activity; duration of morning stiffness of \<=15 minutes. 95% CI was based on normal approximation. 95% CI was based on normal approximation.
Outcome measures
| Measure |
Tofacitinib 5mg BID DB
n=28 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 Participants
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 4
|
7.14 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 8
|
3.57 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 12
|
7.14 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 16
|
3.57 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 20
|
7.14 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 24
|
7.14 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 28
|
10.71 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 32
|
10.71 Percentage of Participants
|
19.35 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 36
|
14.29 Percentage of Participants
|
16.13 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 40
|
17.86 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 44
|
14.29 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 48
|
17.86 Percentage of Participants
|
22.58 Percentage of Participants
|
|
Percentage of Participants With JIA ACR Inactive Disease Status at DB Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52: Double-Blind Phase
DB Week 52
|
21.43 Percentage of Participants
|
19.35 Percentage of Participants
|
Adverse Events
Tofacitinib 5mg BID OL Part 1
Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths
Tofacitinib 5mg BID OL Part 2
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Tofacitinib 5mg BID DB
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo DB
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tofacitinib 5mg BID OL Part 1
n=100 participants at risk
Participants were administered tofacitinib 5 mg BID via the oral route and continued to receive a stable dose of corticosteroids during OL part 1.
|
Tofacitinib 5mg BID OL Part 2
n=54 participants at risk
Participants who achieved sJIA ACR 50 response and maintained sJIA ACR 30 response for 4 weeks were administered tofacitinib 5 mg BID and tapering dose of CSs for participants treated with ˃0.2 mg/kg/day oral prednisone (or equivalent).
|
Tofacitinib 5mg BID DB
n=28 participants at risk
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 participants at risk
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Still's disease
|
3.0%
3/100 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.0%
1/100 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytic necrotising lymphadenitis
|
1.0%
1/100 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
1.0%
1/100 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.0%
1/100 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
Other adverse events
| Measure |
Tofacitinib 5mg BID OL Part 1
n=100 participants at risk
Participants were administered tofacitinib 5 mg BID via the oral route and continued to receive a stable dose of corticosteroids during OL part 1.
|
Tofacitinib 5mg BID OL Part 2
n=54 participants at risk
Participants who achieved sJIA ACR 50 response and maintained sJIA ACR 30 response for 4 weeks were administered tofacitinib 5 mg BID and tapering dose of CSs for participants treated with ˃0.2 mg/kg/day oral prednisone (or equivalent).
|
Tofacitinib 5mg BID DB
n=28 participants at risk
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase continued to receive tofacitinib 5 mg BID orally during the DB withdrawal phase of the study.
|
Placebo DB
n=31 participants at risk
Participants who maintained a stable tapered CS dose for 4 weeks and maintained sJIA ACR 30 for 4 weeks from Part 1 and Part 2 of the OL phase were randomized to receive placebo BID orally during the DB withdrawal phase of the study.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
3/100 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
3/100 • Number of events 4 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
3/100 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
10.7%
3/28 • Number of events 6 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
3/100 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Influenza
|
3.0%
3/100 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
6/100 • Number of events 8 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
7.1%
2/28 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
10/100 • Number of events 11 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
13.0%
7/54 • Number of events 11 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
10.7%
3/28 • Number of events 11 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
16.1%
5/31 • Number of events 19 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
3/100 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
9.7%
3/31 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
General disorders
Pyrexia
|
6.0%
6/100 • Number of events 6 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.7%
2/54 • Number of events 8 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
14.3%
4/28 • Number of events 9 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Blood urine present
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
7.1%
2/28 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Monocyte count increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
Transaminases increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
White blood cell count increased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Nervous system disorders
Headache
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 10 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Eye disorders
Refraction disorder
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.7%
2/54 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
6.5%
2/31 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 7 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
6.5%
2/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 4 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Musculoskeletal and connective tissue disorders
Still's disease
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
5.6%
3/54 • Number of events 4 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
28.6%
8/28 • Number of events 8 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
45.2%
14/31 • Number of events 14 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
7.1%
2/28 • Number of events 3 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
6.5%
2/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
COVID-19
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
9.3%
5/54 • Number of events 5 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
6.5%
2/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Herpangina
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
6.5%
2/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Roseola
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.7%
2/54 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
7.1%
2/28 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
General disorders
Condition aggravated
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
General disorders
Feeling cold
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
7.1%
2/28 • Number of events 2 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/28 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.2%
1/31 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/100 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/54 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
3.6%
1/28 • Number of events 1 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
0.00%
0/31 • From dose 1 up to 28 days after end of study treatment (for OL1=maximum duration up to 16 weeks; for OL2= maximum duration up to 24 weeks and for DB=maximum duration up to 248 weeks)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE. OLPT1, OLPT2 and DBFAS analysis set was used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER