Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis (NCT NCT03963401)

NCT ID: NCT03963401

Last Updated: 2021-08-04

Results Overview

ACR 20 was calculated as a ≥20% improvement in tender and swollen joint counts and ≥20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level). The participants receiving placebo in the initial period (Day 1 - Week 16) were combined into a single placebo group, while those who received PF-06700841 (10 mg QD) in the initial period were combined into a single PF-06700841 10 mg QD group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

219 participants

Primary outcome timeframe

Week 16

Results posted on

2021-08-04

Participant Flow

A total of 219 participants were enrolled in this study and 1 of them didn't receive any study treatment.

Participant milestones

Participant milestones
Measure
PF-06700841 60 mg QD -> PF-06700841 60 mg QD
PF-06700841 tablet was administered orally at 60 milligram (mg) once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 30 mg QD -> PF-06700841 30 mg QD
PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 10 mg QD -> PF-06700841 60 mg QD
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg QD during the extension period (Week 17 through Week 52).
PF-06700841 10 mg QD -> PF-06700841 30 mg QD
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 60 mg QD
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Initial Period (Day 1 - Week 16)
STARTED
60
61
16
15
34
33
Initial Period (Day 1 - Week 16)
Treated
60
60
16
15
34
33
Initial Period (Day 1 - Week 16)
COMPLETED
57
57
14
13
31
31
Initial Period (Day 1 - Week 16)
NOT COMPLETED
3
4
2
2
3
2
Extension Period (Week 17 - Week 52)
STARTED
57
57
14
13
31
31
Extension Period (Week 17 - Week 52)
COMPLETED
43
52
10
12
25
26
Extension Period (Week 17 - Week 52)
NOT COMPLETED
14
5
4
1
6
5

Reasons for withdrawal

Reasons for withdrawal
Measure
PF-06700841 60 mg QD -> PF-06700841 60 mg QD
PF-06700841 tablet was administered orally at 60 milligram (mg) once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 30 mg QD -> PF-06700841 30 mg QD
PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 10 mg QD -> PF-06700841 60 mg QD
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg QD during the extension period (Week 17 through Week 52).
PF-06700841 10 mg QD -> PF-06700841 30 mg QD
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 60 mg QD
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Initial Period (Day 1 - Week 16)
Adverse Event
1
2
0
0
1
2
Initial Period (Day 1 - Week 16)
Lack of Efficacy
0
0
1
1
0
0
Initial Period (Day 1 - Week 16)
Withdrawal by Subject
2
1
1
1
2
0
Initial Period (Day 1 - Week 16)
Randomized but Not Treated
0
1
0
0
0
0
Extension Period (Week 17 - Week 52)
Adverse Event
6
3
2
0
4
3
Extension Period (Week 17 - Week 52)
Lack of Efficacy
1
0
1
0
0
0
Extension Period (Week 17 - Week 52)
Lost to Follow-up
0
0
1
0
0
0
Extension Period (Week 17 - Week 52)
Non-Compliance With Study Drug
1
0
0
0
0
0
Extension Period (Week 17 - Week 52)
Withdrawal by Subject
4
1
0
0
1
1
Extension Period (Week 17 - Week 52)
No Longer Meets Eligibility Criteria
1
0
0
0
0
0
Extension Period (Week 17 - Week 52)
Other
1
1
0
1
1
1

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PF-06700841 60 mg QD -> PF-06700841 60 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 30 mg QD -> PF-06700841 30 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 10 mg QD -> PF-06700841 60 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg QD during the extension period (Week 17 through Week 52).
PF-06700841 10 mg QD -> PF-06700841 30 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Total
n=218 Participants
Total of all reporting groups
Age, Continuous
50.0 Years
n=5 Participants
46.0 Years
n=7 Participants
43.5 Years
n=5 Participants
47.0 Years
n=4 Participants
48.0 Years
n=21 Participants
50.0 Years
n=8 Participants
48.0 Years
n=8 Participants
Age, Customized
18-44
22 Participants
n=5 Participants
26 Participants
n=7 Participants
9 Participants
n=5 Participants
6 Participants
n=4 Participants
13 Participants
n=21 Participants
14 Participants
n=8 Participants
90 Participants
n=8 Participants
Age, Customized
45-64
35 Participants
n=5 Participants
31 Participants
n=7 Participants
5 Participants
n=5 Participants
8 Participants
n=4 Participants
17 Participants
n=21 Participants
16 Participants
n=8 Participants
112 Participants
n=8 Participants
Age, Customized
≥65
3 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
4 Participants
n=21 Participants
3 Participants
n=8 Participants
16 Participants
n=8 Participants
Sex: Female, Male
Female
34 Participants
n=5 Participants
32 Participants
n=7 Participants
7 Participants
n=5 Participants
7 Participants
n=4 Participants
20 Participants
n=21 Participants
16 Participants
n=8 Participants
116 Participants
n=8 Participants
Sex: Female, Male
Male
26 Participants
n=5 Participants
28 Participants
n=7 Participants
9 Participants
n=5 Participants
8 Participants
n=4 Participants
14 Participants
n=21 Participants
17 Participants
n=8 Participants
102 Participants
n=8 Participants
Race/Ethnicity, Customized
White
59 Participants
n=5 Participants
60 Participants
n=7 Participants
16 Participants
n=5 Participants
15 Participants
n=4 Participants
34 Participants
n=21 Participants
33 Participants
n=8 Participants
217 Participants
n=8 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
60 Participants
n=5 Participants
59 Participants
n=7 Participants
16 Participants
n=5 Participants
15 Participants
n=4 Participants
33 Participants
n=21 Participants
32 Participants
n=8 Participants
215 Participants
n=8 Participants
Race/Ethnicity, Customized
Not reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=8 Participants
3 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All participants who received at least 1 dose of the randomized study treatment.

ACR 20 was calculated as a ≥20% improvement in tender and swollen joint counts and ≥20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level). The participants receiving placebo in the initial period (Day 1 - Week 16) were combined into a single placebo group, while those who received PF-06700841 (10 mg QD) in the initial period were combined into a single PF-06700841 10 mg QD group.

Outcome measures

Outcome measures
Measure
Placebo
n=67 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=31 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=59 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
43.28 Percentage of participants
Interval 31.42 to 55.15
64.52 Percentage of participants
Interval 47.67 to 81.36
66.67 Percentage of participants
Interval 54.74 to 78.59
74.58 Percentage of participants
Interval 63.47 to 85.69

SECONDARY outcome

Timeframe: Week 16

Population: All participants who received at least 1 dose of the randomized study treatment with prior TNFα naïve.

ACR 20 was calculated as a ≥20% improvement in tender and swollen joint counts and ≥20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level). The participants receiving placebo in the initial period (Day 1 - Week 16) were combined into a single placebo group, while those who received PF-06700841 (10 mg QD) in the initial period were combined into a single PF-06700841 10 mg QD group.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=28 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=56 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=55 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) α Inhibitor naïve
43.33 Percentage of participants
Interval 30.79 to 55.87
64.29 Percentage of participants
Interval 46.54 to 82.03
69.64 Percentage of participants
Interval 57.6 to 81.69
74.55 Percentage of participants
Interval 63.03 to 86.06

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52

Population: All participants who received at least 1 dose of the randomized study treatment.

The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) was calculated as a ≥20% improvement in tender and swollen joint counts and ≥20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level).

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 2
21.67 Percentage of participants
Interval 11.24 to 32.09
18.33 Percentage of participants
Interval 8.54 to 28.12
18.75 Percentage of participants
Interval 0.0 to 37.87
3.13 Percentage of participants
Interval 0.0 to 11.65
5.88 Percentage of participants
Interval 0.0 to 13.79
18.18 Percentage of participants
Interval 5.02 to 31.34
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 4
45.00 Percentage of participants
Interval 32.41 to 57.59
51.67 Percentage of participants
Interval 39.02 to 64.31
31.25 Percentage of participants
Interval 8.54 to 53.96
20.00 Percentage of participants
Interval 0.0 to 40.24
14.71 Percentage of participants
Interval 2.8 to 26.61
24.24 Percentage of participants
Interval 9.62 to 38.86
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 8
66.67 Percentage of participants
Interval 54.74 to 78.59
55.00 Percentage of participants
Interval 42.41 to 67.59
50.00 Percentage of participants
Interval 25.5 to 74.5
40.00 Percentage of participants
Interval 15.21 to 64.79
35.29 Percentage of participants
Interval 19.23 to 51.36
42.42 Percentage of participants
Interval 25.56 to 59.29
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 12
70.00 Percentage of participants
Interval 58.4 to 81.6
63.33 Percentage of participants
Interval 51.14 to 75.53
56.25 Percentage of participants
Interval 31.94 to 80.56
60.00 Percentage of participants
Interval 35.21 to 84.79
44.12 Percentage of participants
Interval 27.43 to 60.81
39.39 Percentage of participants
Interval 22.72 to 56.07
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 20
81.67 Percentage of participants
Interval 71.88 to 91.46
80.00 Percentage of participants
Interval 69.88 to 90.12
68.75 Percentage of participants
Interval 46.04 to 91.46
60.00 Percentage of participants
Interval 35.21 to 84.79
73.53 Percentage of participants
Interval 58.7 to 88.36
75.76 Percentage of participants
Interval 61.14 to 90.38
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 28
73.33 Percentage of participants
Interval 62.14 to 84.52
78.33 Percentage of participants
Interval 67.91 to 88.76
68.75 Percentage of participants
Interval 46.04 to 91.46
73.33 Percentage of participants
Interval 50.95 to 95.71
64.71 Percentage of participants
Interval 48.64 to 80.77
81.82 Percentage of participants
Interval 68.66 to 94.98
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 36
66.67 Percentage of participants
Interval 54.74 to 78.59
78.33 Percentage of participants
Interval 67.91 to 88.76
68.75 Percentage of participants
Interval 46.04 to 91.46
80.00 Percentage of participants
Interval 59.76 to 100.0
64.71 Percentage of participants
Interval 48.64 to 80.77
81.82 Percentage of participants
Interval 68.66 to 94.98
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 44
68.33 Percentage of participants
Interval 56.56 to 80.1
73.33 Percentage of participants
Interval 62.14 to 84.52
62.50 Percentage of participants
Interval 38.78 to 86.22
73.33 Percentage of participants
Interval 50.95 to 95.71
67.65 Percentage of participants
Interval 51.92 to 83.37
75.76 Percentage of participants
Interval 61.14 to 90.38
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Week 52
61.67 Percentage of participants
Interval 49.36 to 73.97
70.00 Percentage of participants
Interval 58.4 to 81.6
56.25 Percentage of participants
Interval 31.94 to 80.56
60.00 Percentage of participants
Interval 35.21 to 84.79
61.76 Percentage of participants
Interval 45.43 to 78.1
66.67 Percentage of participants
Interval 50.58 to 82.75

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: All participants who received at least 1 dose of the randomized study treatment.

The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR50) was calculated as a ≥50% improvement in tender and swollen joint counts and ≥50% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level).

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
6.67 Percentage of participants
Interval 0.35 to 12.98
1.67 Percentage of participants
Interval 0.0 to 4.91
2.94 Percentage of participants
Interval 0.0 to 10.97
3.13 Percentage of participants
Interval 0.0 to 11.65
1.43 Percentage of participants
Interval 0.0 to 5.36
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
13.33 Percentage of participants
Interval 4.73 to 21.93
16.67 Percentage of participants
Interval 7.24 to 26.1
2.94 Percentage of participants
Interval 0.0 to 10.97
6.67 Percentage of participants
Interval 0.0 to 19.29
2.94 Percentage of participants
Interval 0.0 to 8.62
6.06 Percentage of participants
Interval 0.0 to 14.2
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
31.67 Percentage of participants
Interval 19.9 to 43.44
25.00 Percentage of participants
Interval 14.04 to 35.96
18.75 Percentage of participants
Interval 0.0 to 37.87
13.33 Percentage of participants
Interval 0.0 to 30.54
11.76 Percentage of participants
Interval 0.93 to 22.59
15.15 Percentage of participants
Interval 2.92 to 27.38
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
43.33 Percentage of participants
Interval 30.79 to 55.87
31.67 Percentage of participants
Interval 19.9 to 43.44
31.25 Percentage of participants
Interval 8.54 to 53.96
20.00 Percentage of participants
Interval 0.0 to 40.24
23.53 Percentage of participants
Interval 9.27 to 37.79
12.12 Percentage of participants
Interval 0.99 to 23.26
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
44.07 Percentage of participants
Interval 31.4 to 56.74
48.33 Percentage of participants
Interval 35.69 to 60.98
31.25 Percentage of participants
Interval 8.54 to 53.96
33.33 Percentage of participants
Interval 9.48 to 57.19
14.71 Percentage of participants
Interval 2.8 to 26.61
6.06 Percentage of participants
Interval 0.0 to 14.2
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
61.67 Percentage of participants
Interval 49.36 to 73.97
53.33 Percentage of participants
Interval 40.71 to 65.96
37.50 Percentage of participants
Interval 13.78 to 61.22
40.00 Percentage of participants
Interval 15.21 to 64.79
44.12 Percentage of participants
Interval 27.43 to 60.81
45.45 Percentage of participants
Interval 28.47 to 62.44
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
56.67 Percentage of participants
Interval 44.13 to 69.21
51.67 Percentage of participants
Interval 39.02 to 64.31
43.75 Percentage of participants
Interval 19.44 to 68.06
53.33 Percentage of participants
Interval 28.09 to 78.58
41.18 Percentage of participants
Interval 24.63 to 57.72
66.67 Percentage of participants
Interval 50.58 to 82.75
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
53.33 Percentage of participants
Interval 40.71 to 65.96
56.67 Percentage of participants
Interval 44.13 to 69.21
50.00 Percentage of participants
Interval 25.5 to 74.5
66.67 Percentage of participants
Interval 42.81 to 90.52
50.00 Percentage of participants
Interval 33.19 to 66.81
57.58 Percentage of participants
Interval 40.71 to 74.44
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
56.67 Percentage of participants
Interval 44.13 to 69.21
55.00 Percentage of participants
Interval 42.41 to 67.59
43.75 Percentage of participants
Interval 19.44 to 68.06
60.00 Percentage of participants
Interval 35.21 to 84.79
58.82 Percentage of participants
Interval 42.28 to 75.37
63.64 Percentage of participants
Interval 47.22 to 80.05
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
46.67 Percentage of participants
Interval 34.04 to 59.29
58.33 Percentage of participants
Interval 45.86 to 70.81
43.75 Percentage of participants
Interval 19.44 to 68.06
46.67 Percentage of participants
Interval 21.42 to 71.91
41.18 Percentage of participants
Interval 24.63 to 57.72
51.52 Percentage of participants
Interval 34.46 to 68.57

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: All participants who received at least 1 dose of the randomized study treatment.

The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR70) was calculated as a ≥70% improvement in tender and swollen joint counts and ≥70% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level).

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
3.33 Percentage of participants
Interval 0.0 to 7.88
1.67 Percentage of participants
Interval 0.0 to 4.91
2.94 Percentage of participants
Interval 0.0 to 10.97
3.13 Percentage of participants
Interval 0.0 to 11.65
1.43 Percentage of participants
Interval 0.0 to 5.36
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
5.00 Percentage of participants
Interval 0.0 to 10.51
5.00 Percentage of participants
Interval 0.0 to 10.51
2.94 Percentage of participants
Interval 0.0 to 10.97
3.13 Percentage of participants
Interval 0.0 to 11.65
1.43 Percentage of participants
Interval 0.0 to 5.36
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
11.67 Percentage of participants
Interval 3.54 to 19.79
11.67 Percentage of participants
Interval 3.54 to 19.79
6.25 Percentage of participants
Interval 0.0 to 18.11
3.13 Percentage of participants
Interval 0.0 to 11.65
2.94 Percentage of participants
Interval 0.0 to 8.62
3.03 Percentage of participants
Interval 0.0 to 8.88
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
21.67 Percentage of participants
Interval 11.24 to 32.09
18.33 Percentage of participants
Interval 8.54 to 28.12
6.25 Percentage of participants
Interval 0.0 to 18.11
6.67 Percentage of participants
Interval 0.0 to 19.29
1.43 Percentage of participants
Interval 0.0 to 5.36
9.09 Percentage of participants
Interval 0.0 to 18.9
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
23.73 Percentage of participants
Interval 12.87 to 34.58
26.67 Percentage of participants
Interval 15.48 to 37.86
6.25 Percentage of participants
Interval 0.0 to 18.11
13.33 Percentage of participants
Interval 0.0 to 30.54
1.43 Percentage of participants
Interval 0.0 to 5.36
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
35.00 Percentage of participants
Interval 22.93 to 47.07
30.00 Percentage of participants
Interval 18.4 to 41.6
12.50 Percentage of participants
Interval 0.0 to 28.7
20.00 Percentage of participants
Interval 0.0 to 40.24
23.53 Percentage of participants
Interval 9.27 to 37.79
27.27 Percentage of participants
Interval 12.08 to 42.47
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
36.67 Percentage of participants
Interval 24.47 to 48.86
38.33 Percentage of participants
Interval 26.03 to 50.64
18.75 Percentage of participants
Interval 0.0 to 37.87
26.67 Percentage of participants
Interval 4.29 to 49.05
23.53 Percentage of participants
Interval 9.27 to 37.79
42.42 Percentage of participants
Interval 25.56 to 59.29
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
40.00 Percentage of participants
Interval 27.6 to 52.4
35.00 Percentage of participants
Interval 22.93 to 47.07
37.50 Percentage of participants
Interval 13.78 to 61.22
26.67 Percentage of participants
Interval 4.29 to 49.05
35.29 Percentage of participants
Interval 19.23 to 51.36
39.39 Percentage of participants
Interval 22.72 to 56.07
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
46.67 Percentage of participants
Interval 34.04 to 59.29
45.00 Percentage of participants
Interval 32.41 to 57.59
37.50 Percentage of participants
Interval 13.78 to 61.22
40.00 Percentage of participants
Interval 15.21 to 64.79
23.53 Percentage of participants
Interval 9.27 to 37.79
51.52 Percentage of participants
Interval 34.46 to 68.57
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
38.33 Percentage of participants
Interval 26.03 to 50.64
45.00 Percentage of participants
Interval 32.41 to 57.59
31.25 Percentage of participants
Interval 8.54 to 53.96
26.67 Percentage of participants
Interval 4.29 to 49.05
35.29 Percentage of participants
Interval 19.23 to 51.36
42.42 Percentage of participants
Interval 25.56 to 59.29

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

The tender/painful joints were assessed by a blinded assessor to determine the number of joints that were considered tender/painful using the following scale: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints). Artificial joints was not assessed. Injected joints was counted according to their pre-injection status for the remainder of the study. The assessment was based on 68 joints. The score range was 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-9.4 Units on a scale
Standard Deviation 7.69
-6.8 Units on a scale
Standard Deviation 6.49
-7.9 Units on a scale
Standard Deviation 7.89
-4.4 Units on a scale
Standard Deviation 6.42
-5.0 Units on a scale
Standard Deviation 6.46
-4.6 Units on a scale
Standard Deviation 8.41
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-6.3 Units on a scale
Standard Deviation 7.96
-5.1 Units on a scale
Standard Deviation 5.43
-5.6 Units on a scale
Standard Deviation 8.93
-2.8 Units on a scale
Standard Deviation 4.49
-3.4 Units on a scale
Standard Deviation 5.47
-4.3 Units on a scale
Standard Deviation 8.25
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-3.33 Units on a scale
Standard Deviation 5.23
-2.7 Units on a scale
Standard Deviation 4.49
-4.7 Units on a scale
Standard Deviation 6.37
0.0 Units on a scale
Standard Deviation 2.70
-1.9 Units on a scale
Standard Deviation 3.27
-2.1 Units on a scale
Standard Deviation 5.41
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-9.8 Units on a scale
Standard Deviation 8.19
-8.7 Units on a scale
Standard Deviation 7.27
-11.3 Units on a scale
Standard Deviation 7.32
-6.2 Units on a scale
Standard Deviation 8.43
-6.5 Units on a scale
Standard Deviation 6.69
-6.4 Units on a scale
Standard Deviation 9.40
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-11.1 Units on a scale
Standard Deviation 8.01
-10.1 Units on a scale
Standard Deviation 7.33
-12.0 Units on a scale
Standard Deviation 8.80
-10.4 Units on a scale
Standard Deviation 8.69
-6.5 Units on a scale
Standard Deviation 5.78
-6.5 Units on a scale
Standard Deviation 7.81
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-12.2 Units on a scale
Standard Deviation 8.20
-10.2 Units on a scale
Standard Deviation 6.60
-13.6 Units on a scale
Standard Deviation 9.65
-11.2 Units on a scale
Standard Deviation 10.95
-8.8 Units on a scale
Standard Deviation 5.94
-10.2 Units on a scale
Standard Deviation 7.41
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-12.6 Units on a scale
Standard Deviation 8.38
-10.4 Units on a scale
Standard Deviation 7.04
-14.9 Units on a scale
Standard Deviation 9.99
-13.5 Units on a scale
Standard Deviation 12.21
-9.6 Units on a scale
Standard Deviation 6.39
-11.4 Units on a scale
Standard Deviation 8.13
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-12.5 Units on a scale
Standard Deviation 8.66
-10.7 Units on a scale
Standard Deviation 7.00
-16.2 Units on a scale
Standard Deviation 9.45
-13.8 Units on a scale
Standard Deviation 11.89
-10.4 Units on a scale
Standard Deviation 6.12
-11.4 Units on a scale
Standard Deviation 8.82
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-13.6 Units on a scale
Standard Deviation 8.54
-11.6 Units on a scale
Standard Deviation 7.91
-17.9 Units on a scale
Standard Deviation 10.07
-12.6 Units on a scale
Standard Deviation 13.23
-11.3 Units on a scale
Standard Deviation 6.47
-12.5 Units on a scale
Standard Deviation 9.15
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-13.6 Units on a scale
Standard Deviation 9.11
-11.9 Units on a scale
Standard Deviation 7.69
-18.9 Units on a scale
Standard Deviation 10.74
-13.0 Units on a scale
Standard Deviation 12.25
-10.8 Units on a scale
Standard Deviation 5.53
-12.2 Units on a scale
Standard Deviation 9.81

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

The swollen joints were assessed by a blinded assessor to determine the number of joints that were considered swollen using the following scale: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints). Artificial joints was not assessed. Injected joints was counted according to their pre-injection status for the remainder of the study. The assessment was based on 66 joints. The score range was 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-2.3 Units on a scale
Standard Deviation 3.48
-2.7 Units on a scale
Standard Deviation 3.73
-4.6 Units on a scale
Standard Deviation 5.46
-2.1 Units on a scale
Standard Deviation 3.31
-2.0 Units on a scale
Standard Deviation 3.82
-2.0 Units on a scale
Standard Deviation 3.95
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-4.8 Units on a scale
Standard Deviation 4.42
-4.3 Units on a scale
Standard Deviation 3.64
-5.5 Units on a scale
Standard Deviation 5.51
-5.2 Units on a scale
Standard Deviation 8.14
-2.5 Units on a scale
Standard Deviation 3.11
-3.6 Units on a scale
Standard Deviation 5.61
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-6.5 Units on a scale
Standard Deviation 5.42
-5.9 Units on a scale
Standard Deviation 4.50
-7.9 Units on a scale
Standard Deviation 4.72
-7.5 Units on a scale
Standard Deviation 7.54
-4.4 Units on a scale
Standard Deviation 5.42
-4.4 Units on a scale
Standard Deviation 5.95
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-7.1 Units on a scale
Standard Deviation 5.89
-6.7 Units on a scale
Standard Deviation 4.69
-8.7 Units on a scale
Standard Deviation 6.97
-8.7 Units on a scale
Standard Deviation 8.04
-5.4 Units on a scale
Standard Deviation 5.26
-4.7 Units on a scale
Standard Deviation 6.05
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-8.0 Units on a scale
Standard Deviation 5.53
-7.6 Units on a scale
Standard Deviation 5.10
-8.9 Units on a scale
Standard Deviation 7.94
-9.9 Units on a scale
Standard Deviation 8.98
-6.7 Units on a scale
Standard Deviation 5.80
-5.5 Units on a scale
Standard Deviation 6.74
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-8.5 Units on a scale
Standard Deviation 5.31
-8.3 Units on a scale
Standard Deviation 5.12
-10.5 Units on a scale
Standard Deviation 8.42
-10.8 Units on a scale
Standard Deviation 9.10
-8.0 Units on a scale
Standard Deviation 6.29
-7.6 Units on a scale
Standard Deviation 5.15
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-8.2 Units on a scale
Standard Deviation 4.34
-7.7 Units on a scale
Standard Deviation 5.27
-10.0 Units on a scale
Standard Deviation 7.66
-10.9 Units on a scale
Standard Deviation 9.00
-7.2 Units on a scale
Standard Deviation 5.79
-8.5 Units on a scale
Standard Deviation 5.83
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-8.1 Units on a scale
Standard Deviation 4.35
-8.1 Units on a scale
Standard Deviation 4.97
-10.5 Units on a scale
Standard Deviation 7.55
-11.1 Units on a scale
Standard Deviation 9.30
-8.4 Units on a scale
Standard Deviation 5.60
-8.9 Units on a scale
Standard Deviation 5.71
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-8.3 Units on a scale
Standard Deviation 4.87
-8.2 Units on a scale
Standard Deviation 5.05
-10.5 Units on a scale
Standard Deviation 6.84
-10.8 Units on a scale
Standard Deviation 9.93
-8.3 Units on a scale
Standard Deviation 5.57
-9.5 Units on a scale
Standard Deviation 5.51
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-8.2 Units on a scale
Standard Deviation 4.84
-8.1 Units on a scale
Standard Deviation 4.84
-11.1 Units on a scale
Standard Deviation 7.68
-10.7 Units on a scale
Standard Deviation 9.55
-8.5 Units on a scale
Standard Deviation 5.76
-9.2 Units on a scale
Standard Deviation 6.19

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. VAS data was rescaled prior to any calculation and analysis. Rescaled VAS score (mm) = (100 mm) × (length at mark in mm/overall length of line in mm). The score range was 0 mm to 100 mm, with a higher score indicating a higher degree of pain. A negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-7.6 mm
Standard Deviation 19.13
-8.0 mm
Standard Deviation 17.96
-5.3 mm
Standard Deviation 12.87
1.7 mm
Standard Deviation 21.20
-2.3 mm
Standard Deviation 11.89
-9.0 mm
Standard Deviation 17.52
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-13.4 mm
Standard Deviation 23.39
-18.5 mm
Standard Deviation 20.32
-12.4 mm
Standard Deviation 22.60
-7.9 mm
Standard Deviation 22.69
-10.1 mm
Standard Deviation 18.67
-9.6 mm
Standard Deviation 18.15
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-20.6 mm
Standard Deviation 23.55
-21.0 mm
Standard Deviation 22.46
-14.3 mm
Standard Deviation 27.34
-10.7 mm
Standard Deviation 25.94
-16.9 mm
Standard Deviation 22.67
-13.1 mm
Standard Deviation 22.88
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-24.7 mm
Standard Deviation 25.72
-22.8 mm
Standard Deviation 22.19
-21.8 mm
Standard Deviation 24.25
-14.9 mm
Standard Deviation 24.90
-14.2 mm
Standard Deviation 24.54
-12.3 mm
Standard Deviation 24.44
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-28.4 mm
Standard Deviation 24.13
-25.0 mm
Standard Deviation 22.58
-26.5 mm
Standard Deviation 23.41
-30.2 mm
Standard Deviation 20.55
-13.7 mm
Standard Deviation 22.14
-14.6 mm
Standard Deviation 20.16
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-29.5 mm
Standard Deviation 24.12
-30.9 mm
Standard Deviation 22.91
-29.3 mm
Standard Deviation 24.07
-25.5 mm
Standard Deviation 29.91
-32.1 mm
Standard Deviation 22.84
-27.7 mm
Standard Deviation 26.78
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-29.7 mm
Standard Deviation 22.88
-32.2 mm
Standard Deviation 25.21
-34.6 mm
Standard Deviation 21.85
-35.2 mm
Standard Deviation 24.79
-29.6 mm
Standard Deviation 27.49
-37.4 mm
Standard Deviation 25.54
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-31.6 mm
Standard Deviation 25.14
-31.3 mm
Standard Deviation 26.58
-37.0 mm
Standard Deviation 29.87
-33.5 mm
Standard Deviation 36.99
-32.4 mm
Standard Deviation 21.11
-38.5 mm
Standard Deviation 26.34
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-32.8 mm
Standard Deviation 26.90
-36.5 mm
Standard Deviation 26.87
-41.6 mm
Standard Deviation 16.12
-34.1 mm
Standard Deviation 39.69
-35.0 mm
Standard Deviation 23.36
-40.0 mm
Standard Deviation 26.21
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-31.4 mm
Standard Deviation 26.39
-35.5 mm
Standard Deviation 27.76
-39.6 mm
Standard Deviation 21.95
-34.9 mm
Standard Deviation 31.79
-38.3 mm
Standard Deviation 22.84
-38.5 mm
Standard Deviation 25.29

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?". The participant's response was recorded using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (very well) and 100 (very poorly). VAS data was rescaled prior to any calculation and analysis. Rescaled VAS score (mm) = (100 mm) × (length at mark in mm/overall length of line in mm). The score range was 0 mm to 100 mm, and a negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-6.3 mm
Standard Deviation 21.52
-10.9 mm
Standard Deviation 17.85
-5.4 mm
Standard Deviation 17.59
2.6 mm
Standard Deviation 19.66
-0.1 mm
Standard Deviation 17.33
-7.8 mm
Standard Deviation 17.02
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-14.4 mm
Standard Deviation 25.55
-20.5 mm
Standard Deviation 20.60
-12.3 mm
Standard Deviation 18.09
-8.9 mm
Standard Deviation 16.46
-2.0 mm
Standard Deviation 20.76
-3.3 mm
Standard Deviation 17.34
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-19.4 mm
Standard Deviation 24.61
-21.9 mm
Standard Deviation 24.29
-14.0 mm
Standard Deviation 21.37
-12.7 mm
Standard Deviation 19.88
-11.0 mm
Standard Deviation 26.22
-7.0 mm
Standard Deviation 22.38
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-21.8 mm
Standard Deviation 26.15
-26.2 mm
Standard Deviation 21.18
-20.0 mm
Standard Deviation 24.36
-12.4 mm
Standard Deviation 21.29
-12.2 mm
Standard Deviation 26.00
-8.0 mm
Standard Deviation 25.46
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-27.8 mm
Standard Deviation 22.31
-27.3 mm
Standard Deviation 21.62
-26.1 mm
Standard Deviation 25.26
-26.7 mm
Standard Deviation 19.05
-9.3 mm
Standard Deviation 23.48
-9.4 mm
Standard Deviation 21.11
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-26.8 mm
Standard Deviation 23.84
-31.4 mm
Standard Deviation 21.81
-27.6 mm
Standard Deviation 23.49
-22.8 mm
Standard Deviation 31.26
-28.8 mm
Standard Deviation 25.44
-25.5 mm
Standard Deviation 24.96
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-29.4 mm
Standard Deviation 20.78
-34.0 mm
Standard Deviation 23.87
-33.9 mm
Standard Deviation 22.09
-33.7 mm
Standard Deviation 23.46
-31.7 mm
Standard Deviation 24.10
-33.9 mm
Standard Deviation 23.79
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-30.1 mm
Standard Deviation 23.65
-34.1 mm
Standard Deviation 26.03
-37.2 mm
Standard Deviation 29.10
-30.7 mm
Standard Deviation 39.29
-28.5 mm
Standard Deviation 21.25
-34.9 mm
Standard Deviation 24.80
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-31.5 mm
Standard Deviation 24.77
-34.9 mm
Standard Deviation 24.41
-38.2 mm
Standard Deviation 22.88
-33.0 mm
Standard Deviation 39.17
-28.7 mm
Standard Deviation 23.22
-35.6 mm
Standard Deviation 26.55
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-32.0 mm
Standard Deviation 24.63
-35.2 mm
Standard Deviation 28.60
-36.8 mm
Standard Deviation 23.09
-29.6 mm
Standard Deviation 32.56
-34.9 mm
Standard Deviation 25.24
-32.1 mm
Standard Deviation 28.85

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

The blinded assessor assessed the participant's overall arthritis appears at the time of each visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (very good) and 100 (very poor). VAS data was rescaled prior to any calculation and analysis. Rescaled VAS score (mm) = (100 mm) × (length at mark in mm/overall length of line in mm). The score range was 0 mm to 100 mm, and a negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-46.6 mm
Standard Deviation 21.73
-43.4 mm
Standard Deviation 20.36
-54.1 mm
Standard Deviation 15.18
-42.7 mm
Standard Deviation 23.34
-36.3 mm
Standard Deviation 21.01
-41.9 mm
Standard Deviation 22.66
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-9.2 mm
Standard Deviation 15.59
-9.0 mm
Standard Deviation 14.87
-9.9 mm
Standard Deviation 14.55
-1.9 mm
Standard Deviation 10.79
-3.4 mm
Standard Deviation 11.92
-7.2 mm
Standard Deviation 13.64
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-19.8 mm
Standard Deviation 18.98
-17.6 mm
Standard Deviation 18.37
-18.3 mm
Standard Deviation 22.31
-11.1 mm
Standard Deviation 13.99
-8.8 mm
Standard Deviation 17.67
-9.5 mm
Standard Deviation 18.08
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-30.6 mm
Standard Deviation 19.43
-25.0 mm
Standard Deviation 18.02
-28.7 mm
Standard Deviation 15.73
-16.4 mm
Standard Deviation 21.08
-16.3 mm
Standard Deviation 20.97
-11.9 mm
Standard Deviation 17.94
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-35.2 mm
Standard Deviation 19.92
-30.1 mm
Standard Deviation 16.85
-31.1 mm
Standard Deviation 20.62
-21.2 mm
Standard Deviation 22.01
-16.5 mm
Standard Deviation 21.57
-13.7 mm
Standard Deviation 22.30
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-37.7 mm
Standard Deviation 20.59
-33.7 mm
Standard Deviation 17.89
-31.2 mm
Standard Deviation 20.00
-32.5 mm
Standard Deviation 23.98
-16.5 mm
Standard Deviation 23.34
-14.4 mm
Standard Deviation 27.76
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-41.8 mm
Standard Deviation 19.91
-37.8 mm
Standard Deviation 19.48
-38.7 mm
Standard Deviation 24.67
-34.7 mm
Standard Deviation 26.16
-31.0 mm
Standard Deviation 22.29
-27.1 mm
Standard Deviation 25.41
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-42.0 mm
Standard Deviation 21.42
-36.7 mm
Standard Deviation 21.91
-47.6 mm
Standard Deviation 21.44
-42.4 mm
Standard Deviation 23.28
-32.7 mm
Standard Deviation 22.03
-38.8 mm
Standard Deviation 20.53
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-42.7 mm
Standard Deviation 22.92
-36.8 mm
Standard Deviation 23.05
-46.3 mm
Standard Deviation 22.42
-43.4 mm
Standard Deviation 20.30
-38.0 mm
Standard Deviation 19.52
-42.6 mm
Standard Deviation 20.41
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-44.5 mm
Standard Deviation 20.15
-40.6 mm
Standard Deviation 22.19
-51.9 mm
Standard Deviation 15.81
-43.2 mm
Standard Deviation 25.55
-36.4 mm
Standard Deviation 20.54
-44.9 mm
Standard Deviation 20.40

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

The HAQ-DI assessed the degree of difficulty a participant experienced in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range was 0 to 3, with a higher score indicating more difficulty in performing daily living activities. A negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-0.133 Units on a scale
Standard Deviation 0.4273
-0.177 Units on a scale
Standard Deviation 0.3489
-0.195 Units on a scale
Standard Deviation 0.2886
-0.117 Units on a scale
Standard Deviation 0.4212
-0.030 Units on a scale
Standard Deviation 0.4572
-0.170 Units on a scale
Standard Deviation 0.3091
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-0.521 Units on a scale
Standard Deviation 0.6197
-0.581 Units on a scale
Standard Deviation 0.5321
-0.563 Units on a scale
Standard Deviation 0.3830
-0.510 Units on a scale
Standard Deviation 0.5576
-0.370 Units on a scale
Standard Deviation 0.4210
-0.576 Units on a scale
Standard Deviation 0.5757
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-0.503 Units on a scale
Standard Deviation 0.6023
-0.567 Units on a scale
Standard Deviation 0.4866
-0.500 Units on a scale
Standard Deviation 0.5137
-0.552 Units on a scale
Standard Deviation 0.5041
-0.411 Units on a scale
Standard Deviation 0.3695
-0.514 Units on a scale
Standard Deviation 0.5704
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-0.248 Units on a scale
Standard Deviation 0.5341
-0.315 Units on a scale
Standard Deviation 0.3777
-0.180 Units on a scale
Standard Deviation 0.2090
-0.217 Units on a scale
Standard Deviation 0.3356
-0.095 Units on a scale
Standard Deviation 0.4931
-0.170 Units on a scale
Standard Deviation 0.3305
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-0.343 Units on a scale
Standard Deviation 0.5690
-0.421 Units on a scale
Standard Deviation 0.4103
-0.188 Units on a scale
Standard Deviation 0.4472
-0.277 Units on a scale
Standard Deviation 0.3609
-0.184 Units on a scale
Standard Deviation 0.4959
-0.249 Units on a scale
Standard Deviation 0.4465
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-0.366 Units on a scale
Standard Deviation 0.5701
-0.478 Units on a scale
Standard Deviation 0.4167
-0.214 Units on a scale
Standard Deviation 0.4230
-0.304 Units on a scale
Standard Deviation 0.2930
-0.121 Units on a scale
Standard Deviation 0.4910
-0.239 Units on a scale
Standard Deviation 0.4660
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-0.474 Units on a scale
Standard Deviation 0.5158
-0.509 Units on a scale
Standard Deviation 0.3994
-0.321 Units on a scale
Standard Deviation 0.3914
-0.375 Units on a scale
Standard Deviation 0.3385
-0.109 Units on a scale
Standard Deviation 0.5271
-0.246 Units on a scale
Standard Deviation 0.3729
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-0.466 Units on a scale
Standard Deviation 0.5546
-0.576 Units on a scale
Standard Deviation 0.4906
-0.404 Units on a scale
Standard Deviation 0.4681
-0.308 Units on a scale
Standard Deviation 0.4610
-0.363 Units on a scale
Standard Deviation 0.4983
-0.472 Units on a scale
Standard Deviation 0.4934
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-0.524 Units on a scale
Standard Deviation 0.5412
-0.583 Units on a scale
Standard Deviation 0.5262
-0.519 Units on a scale
Standard Deviation 0.4531
-0.490 Units on a scale
Standard Deviation 0.5064
-0.422 Units on a scale
Standard Deviation 0.4811
-0.517 Units on a scale
Standard Deviation 0.5520
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-0.520 Units on a scale
Standard Deviation 0.6051
-0.594 Units on a scale
Standard Deviation 0.4990
-0.577 Units on a scale
Standard Deviation 0.5740
-0.519 Units on a scale
Standard Deviation 0.5633
-0.329 Units on a scale
Standard Deviation 0.3816
-0.547 Units on a scale
Standard Deviation 0.5867

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included all the participants in the pharmacodynamic (PD) analysis population who received at least one dose of randomized study treatment and in whom at least one value of the PD parameter of interest was reported. "Number Analyzed" included participants available in the PD analysis population at each specified visit.

C-reactive protein (hsCRP) is an acute phase reactant, which is indicative of inflammation and of its severity. Blood samples were obtained at Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 for determination of hsCRP.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-4.420 milligram per liter (mg/L)
Standard Deviation 8.9409
-3.696 milligram per liter (mg/L)
Standard Deviation 11.9628
-6.023 milligram per liter (mg/L)
Standard Deviation 19.1126
-0.595 milligram per liter (mg/L)
Standard Deviation 1.4661
-1.641 milligram per liter (mg/L)
Standard Deviation 10.4224
1.462 milligram per liter (mg/L)
Standard Deviation 7.8966
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-3.645 milligram per liter (mg/L)
Standard Deviation 11.8144
-5.543 milligram per liter (mg/L)
Standard Deviation 11.9617
-6.134 milligram per liter (mg/L)
Standard Deviation 19.5633
-1.324 milligram per liter (mg/L)
Standard Deviation 1.9735
0.010 milligram per liter (mg/L)
Standard Deviation 7.0206
1.206 milligram per liter (mg/L)
Standard Deviation 5.4423
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-3.828 milligram per liter (mg/L)
Standard Deviation 10.8093
-5.102 milligram per liter (mg/L)
Standard Deviation 11.5408
-6.029 milligram per liter (mg/L)
Standard Deviation 19.9534
-0.573 milligram per liter (mg/L)
Standard Deviation 2.6595
-2.598 milligram per liter (mg/L)
Standard Deviation 10.7270
0.927 milligram per liter (mg/L)
Standard Deviation 6.2062
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-3.759 milligram per liter (mg/L)
Standard Deviation 11.0481
-5.881 milligram per liter (mg/L)
Standard Deviation 12.9484
-7.335 milligram per liter (mg/L)
Standard Deviation 22.0149
-1.177 milligram per liter (mg/L)
Standard Deviation 3.4854
-1.061 milligram per liter (mg/L)
Standard Deviation 11.1944
1.021 milligram per liter (mg/L)
Standard Deviation 6.6025
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-3.695 milligram per liter (mg/L)
Standard Deviation 8.1064
-5.809 milligram per liter (mg/L)
Standard Deviation 13.6463
-5.420 milligram per liter (mg/L)
Standard Deviation 21.9622
1.060 milligram per liter (mg/L)
Standard Deviation 8.7842
-2.218 milligram per liter (mg/L)
Standard Deviation 11.6164
-0.762 milligram per liter (mg/L)
Standard Deviation 6.5779
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-4.581 milligram per liter (mg/L)
Standard Deviation 10.5026
-6.014 milligram per liter (mg/L)
Standard Deviation 14.7723
-7.879 milligram per liter (mg/L)
Standard Deviation 24.2763
-0.989 milligram per liter (mg/L)
Standard Deviation 3.6969
-5.982 milligram per liter (mg/L)
Standard Deviation 10.4711
-4.718 milligram per liter (mg/L)
Standard Deviation 7.1896
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-4.277 milligram per liter (mg/L)
Standard Deviation 12.9069
-6.362 milligram per liter (mg/L)
Standard Deviation 13.6372
-8.679 milligram per liter (mg/L)
Standard Deviation 24.9759
-1.300 milligram per liter (mg/L)
Standard Deviation 3.7971
-6.112 milligram per liter (mg/L)
Standard Deviation 10.6756
-5.484 milligram per liter (mg/L)
Standard Deviation 10.0475
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-4.899 milligram per liter (mg/L)
Standard Deviation 10.3015
-5.940 milligram per liter (mg/L)
Standard Deviation 14.4219
-9.461 milligram per liter (mg/L)
Standard Deviation 25.7767
-1.814 milligram per liter (mg/L)
Standard Deviation 3.0658
-6.247 milligram per liter (mg/L)
Standard Deviation 9.8145
-5.029 milligram per liter (mg/L)
Standard Deviation 9.1947
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-5.543 milligram per liter (mg/L)
Standard Deviation 11.7058
-6.215 milligram per liter (mg/L)
Standard Deviation 14.2493
-2.196 milligram per liter (mg/L)
Standard Deviation 2.2859
-0.987 milligram per liter (mg/L)
Standard Deviation 3.7325
-4.690 milligram per liter (mg/L)
Standard Deviation 9.9495
-0.711 milligram per liter (mg/L)
Standard Deviation 13.7530
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-5.167 milligram per liter (mg/L)
Standard Deviation 13.3963
-4.880 milligram per liter (mg/L)
Standard Deviation 14.1148
-1.586 milligram per liter (mg/L)
Standard Deviation 3.0576
-2.028 milligram per liter (mg/L)
Standard Deviation 3.2177
-4.324 milligram per liter (mg/L)
Standard Deviation 7.7335
-4.722 milligram per liter (mg/L)
Standard Deviation 9.3318

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included a subgroup of participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline BSA ≥3% and PASI \>0 . "Number Analyzed" included participants available in the evaluable population at each specified visit with baseline BSA ≥3% and PASI \>0.

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 indicates a 75% or greater reduction in PASI scores from baseline.

Outcome measures

Outcome measures
Measure
Placebo
n=40 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=39 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=12 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=9 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=22 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=19 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
5.00 Percentage of participants
Interval 0.0 to 11.75
2.56 Percentage of participants
Interval 0.0 to 7.52
3.85 Percentage of participants
Interval 0.0 to 14.3
11.11 Percentage of participants
Interval 0.0 to 31.64
2.17 Percentage of participants
Interval 0.0 to 8.13
5.26 Percentage of participants
Interval 0.0 to 15.3
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
30.00 Percentage of participants
Interval 15.8 to 44.2
12.82 Percentage of participants
Interval 2.33 to 23.31
3.85 Percentage of participants
Interval 0.0 to 14.3
11.11 Percentage of participants
Interval 0.0 to 31.64
4.55 Percentage of participants
Interval 0.0 to 13.25
5.26 Percentage of participants
Interval 0.0 to 15.3
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
45.00 Percentage of participants
Interval 29.58 to 60.42
41.03 Percentage of participants
Interval 25.59 to 56.46
25.00 Percentage of participants
Interval 0.5 to 49.5
11.11 Percentage of participants
Interval 0.0 to 31.64
9.09 Percentage of participants
Interval 0.0 to 21.1
15.79 Percentage of participants
Interval 0.0 to 32.19
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
60.00 Percentage of participants
Interval 44.82 to 75.18
48.72 Percentage of participants
Interval 33.03 to 64.41
33.33 Percentage of participants
Interval 6.66 to 60.01
33.33 Percentage of participants
Interval 2.54 to 64.13
18.18 Percentage of participants
Interval 2.06 to 34.3
21.05 Percentage of participants
Interval 2.72 to 39.38
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
69.23 Percentage of participants
Interval 54.75 to 83.72
58.97 Percentage of participants
Interval 43.54 to 74.41
58.33 Percentage of participants
Interval 30.44 to 86.23
55.56 Percentage of participants
Interval 23.09 to 88.02
22.73 Percentage of participants
Interval 5.22 to 40.24
26.32 Percentage of participants
Interval 6.52 to 46.12
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
72.50 Percentage of participants
Interval 58.66 to 86.34
61.54 Percentage of participants
Interval 46.27 to 76.81
66.67 Percentage of participants
Interval 39.99 to 93.34
55.56 Percentage of participants
Interval 23.09 to 88.02
54.55 Percentage of participants
Interval 33.74 to 75.35
36.84 Percentage of participants
Interval 15.15 to 58.53
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
70.00 Percentage of participants
Interval 55.8 to 84.2
51.28 Percentage of participants
Interval 35.59 to 66.97
91.67 Percentage of participants
Interval 76.03 to 100.0
77.78 Percentage of participants
Interval 50.62 to 100.0
63.64 Percentage of participants
Interval 43.54 to 83.74
63.16 Percentage of participants
Interval 41.47 to 84.85
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
70.00 Percentage of participants
Interval 55.8 to 84.2
64.10 Percentage of participants
Interval 49.05 to 79.16
96.15 Percentage of participants
Interval 85.7 to 100.0
88.89 Percentage of participants
Interval 68.36 to 100.0
59.09 Percentage of participants
Interval 38.55 to 79.64
47.37 Percentage of participants
Interval 24.92 to 69.82
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
75.00 Percentage of participants
Interval 61.58 to 88.42
66.67 Percentage of participants
Interval 51.87 to 81.46
75.00 Percentage of participants
Interval 50.5 to 99.5
55.56 Percentage of participants
Interval 23.09 to 88.02
63.64 Percentage of participants
Interval 43.54 to 83.74
63.16 Percentage of participants
Interval 41.47 to 84.85
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
65.00 Percentage of participants
Interval 50.22 to 79.78
66.67 Percentage of participants
Interval 51.87 to 81.46
66.67 Percentage of participants
Interval 39.99 to 93.34
66.67 Percentage of participants
Interval 35.87 to 97.46
50.00 Percentage of participants
Interval 29.11 to 70.89
57.89 Percentage of participants
Interval 35.69 to 80.1

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included a subgroup of participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline BSA ≥3% and PASI \>0 . "Number Analyzed" included participants available in the evaluable population at each specified visit with baseline BSA ≥3% and PASI \>0.

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 indicates a 90% or greater reduction in PASI scores from baseline.

Outcome measures

Outcome measures
Measure
Placebo
n=40 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=39 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=12 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=9 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=22 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=19 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
1.22 Percentage of participants
Interval 0.0 to 4.58
1.25 Percentage of participants
Interval 0.0 to 4.69
3.85 Percentage of participants
Interval 0.0 to 14.3
11.11 Percentage of participants
Interval 0.0 to 31.64
2.17 Percentage of participants
Interval 0.0 to 8.13
2.50 Percentage of participants
Interval 0.0 to 9.34
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
17.50 Percentage of participants
Interval 5.72 to 29.28
5.13 Percentage of participants
Interval 0.0 to 12.05
3.85 Percentage of participants
Interval 0.0 to 14.3
11.11 Percentage of participants
Interval 0.0 to 31.64
4.55 Percentage of participants
Interval 0.0 to 13.25
2.50 Percentage of participants
Interval 0.0 to 9.34
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
35.00 Percentage of participants
Interval 20.22 to 49.78
17.95 Percentage of participants
Interval 5.9 to 29.99
16.67 Percentage of participants
Interval 0.0 to 37.75
11.11 Percentage of participants
Interval 0.0 to 31.64
2.17 Percentage of participants
Interval 0.0 to 8.13
5.26 Percentage of participants
Interval 0.0 to 15.3
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
47.50 Percentage of participants
Interval 32.02 to 62.98
25.64 Percentage of participants
Interval 11.94 to 39.35
16.67 Percentage of participants
Interval 0.0 to 37.75
22.22 Percentage of participants
Interval 0.0 to 49.38
2.17 Percentage of participants
Interval 0.0 to 8.13
10.53 Percentage of participants
Interval 0.0 to 24.33
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
53.85 Percentage of participants
Interval 38.2 to 69.49
33.33 Percentage of participants
Interval 18.54 to 48.13
33.33 Percentage of participants
Interval 6.66 to 60.01
33.33 Percentage of participants
Interval 2.54 to 64.13
9.09 Percentage of participants
Interval 0.0 to 21.1
15.79 Percentage of participants
Interval 0.0 to 32.19
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
50.00 Percentage of participants
Interval 34.51 to 65.49
43.59 Percentage of participants
Interval 28.03 to 59.15
50.00 Percentage of participants
Interval 21.71 to 78.29
44.44 Percentage of participants
Interval 11.98 to 76.91
18.18 Percentage of participants
Interval 2.06 to 34.3
26.32 Percentage of participants
Interval 6.52 to 46.12
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
52.50 Percentage of participants
Interval 37.02 to 67.98
38.46 Percentage of participants
Interval 23.19 to 53.73
58.33 Percentage of participants
Interval 30.44 to 86.23
44.44 Percentage of participants
Interval 11.98 to 76.91
50.00 Percentage of participants
Interval 29.11 to 70.89
31.58 Percentage of participants
Interval 10.68 to 52.48
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
62.50 Percentage of participants
Interval 47.5 to 77.5
48.72 Percentage of participants
Interval 33.03 to 64.41
83.33 Percentage of participants
Interval 62.25 to 100.0
66.67 Percentage of participants
Interval 35.87 to 97.46
45.45 Percentage of participants
Interval 24.65 to 66.26
36.84 Percentage of participants
Interval 15.15 to 58.53
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
52.50 Percentage of participants
Interval 37.02 to 67.98
48.72 Percentage of participants
Interval 33.03 to 64.41
66.67 Percentage of participants
Interval 39.99 to 93.34
44.44 Percentage of participants
Interval 11.98 to 76.91
50.00 Percentage of participants
Interval 29.11 to 70.89
52.63 Percentage of participants
Interval 30.18 to 75.08
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
40.00 Percentage of participants
Interval 24.82 to 55.18
56.41 Percentage of participants
Interval 40.85 to 71.97
66.67 Percentage of participants
Interval 39.99 to 93.34
55.56 Percentage of participants
Interval 23.09 to 88.02
45.45 Percentage of participants
Interval 24.65 to 66.26
47.37 Percentage of participants
Interval 24.92 to 69.82

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included a subgroup of participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline BSA ≥3% and PASI \>0 . "Number Analyzed" included participants available in the evaluable population at each specified visit with baseline BSA ≥3% and PASI \>0.

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 indicates a 100% reduction in PASI scores from baseline.

Outcome measures

Outcome measures
Measure
Placebo
n=40 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=39 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=12 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=9 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=22 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=19 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
1.22 Percentage of participants
Interval 0.0 to 4.58
1.25 Percentage of participants
Interval 0.0 to 4.69
3.85 Percentage of participants
Interval 0.0 to 14.3
11.11 Percentage of participants
Interval 0.0 to 31.64
2.17 Percentage of participants
Interval 0.0 to 8.13
2.50 Percentage of participants
Interval 0.0 to 9.34
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
7.50 Percentage of participants
Interval 0.0 to 15.66
1.25 Percentage of participants
Interval 0.0 to 4.69
3.85 Percentage of participants
Interval 0.0 to 14.3
5.00 Percentage of participants
Interval 0.0 to 18.51
4.55 Percentage of participants
Interval 0.0 to 13.25
2.50 Percentage of participants
Interval 0.0 to 9.34
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
20.00 Percentage of participants
Interval 7.6 to 32.4
5.13 Percentage of participants
Interval 0.0 to 12.05
8.33 Percentage of participants
Interval 0.0 to 23.97
11.11 Percentage of participants
Interval 0.0 to 31.64
2.17 Percentage of participants
Interval 0.0 to 8.13
2.50 Percentage of participants
Interval 0.0 to 9.34
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
35.00 Percentage of participants
Interval 20.22 to 49.78
7.69 Percentage of participants
Interval 0.0 to 16.06
8.33 Percentage of participants
Interval 0.0 to 23.97
11.11 Percentage of participants
Interval 0.0 to 31.64
2.17 Percentage of participants
Interval 0.0 to 8.13
5.26 Percentage of participants
Interval 0.0 to 15.3
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
35.90 Percentage of participants
Interval 20.84 to 50.95
15.38 Percentage of participants
Interval 4.06 to 26.71
16.67 Percentage of participants
Interval 0.0 to 37.75
33.33 Percentage of participants
Interval 2.54 to 64.13
9.09 Percentage of participants
Interval 0.0 to 21.1
10.53 Percentage of participants
Interval 0.0 to 24.33
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
27.50 Percentage of participants
Interval 13.66 to 41.34
35.90 Percentage of participants
Interval 20.84 to 50.95
33.33 Percentage of participants
Interval 6.66 to 60.01
44.44 Percentage of participants
Interval 11.98 to 76.91
13.64 Percentage of participants
Interval 0.0 to 27.98
10.53 Percentage of participants
Interval 0.0 to 24.33
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
35.00 Percentage of participants
Interval 20.22 to 49.78
30.77 Percentage of participants
Interval 16.28 to 45.25
50.00 Percentage of participants
Interval 21.71 to 78.29
44.44 Percentage of participants
Interval 11.98 to 76.91
40.91 Percentage of participants
Interval 20.36 to 61.45
21.05 Percentage of participants
Interval 2.72 to 39.38
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
40.00 Percentage of participants
Interval 24.82 to 55.18
35.90 Percentage of participants
Interval 20.84 to 50.95
50.00 Percentage of participants
Interval 21.71 to 78.29
55.56 Percentage of participants
Interval 23.09 to 88.02
36.36 Percentage of participants
Interval 16.26 to 56.46
21.05 Percentage of participants
Interval 2.72 to 39.38
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
30.00 Percentage of participants
Interval 15.8 to 44.2
41.03 Percentage of participants
Interval 25.59 to 56.46
58.33 Percentage of participants
Interval 30.44 to 86.23
44.44 Percentage of participants
Interval 11.98 to 76.91
31.82 Percentage of participants
Interval 12.36 to 51.28
42.11 Percentage of participants
Interval 19.9 to 64.31
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
35.00 Percentage of participants
Interval 20.22 to 49.78
38.46 Percentage of participants
Interval 23.19 to 53.73
41.67 Percentage of participants
Interval 13.77 to 69.56
33.33 Percentage of participants
Interval 2.54 to 64.13
36.36 Percentage of participants
Interval 16.26 to 56.46
42.11 Percentage of participants
Interval 19.9 to 64.31

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included all the participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline SPARCC enthesitis score\>0. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline SPARCC enthesitis score \>0.

The SPARCC Enthesitis Index examines tenderness at sixteen sites: medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle (considered 1 site for scoring purposes), Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. Each site is classified on a dichotomous basis as either tender (score=1) or not tender (score=0). The SPARCC Enthesitis Index scores range from 0-16, with higher scores indicating higher disease activity.

Outcome measures

Outcome measures
Measure
Placebo
n=38 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=34 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=11 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=9 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=21 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=19 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-0.6 Units on a scale
Standard Deviation 1.55
-0.3 Units on a scale
Standard Deviation 2.73
-1.4 Units on a scale
Standard Deviation 1.86
0.0 Units on a scale
Standard Deviation 1.12
-0.2 Units on a scale
Standard Deviation 1.79
-0.3 Units on a scale
Standard Deviation 2.67
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-1.4 Units on a scale
Standard Deviation 2.41
-0.9 Units on a scale
Standard Deviation 2.32
-1.3 Units on a scale
Standard Deviation 2.37
0.0 Units on a scale
Standard Deviation 1.41
-1.0 Units on a scale
Standard Deviation 2.29
-1.0 Units on a scale
Standard Deviation 2.81
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-1.9 Units on a scale
Standard Deviation 2.11
-1.9 Units on a scale
Standard Deviation 2.23
-1.4 Units on a scale
Standard Deviation 1.80
-1.0 Units on a scale
Standard Deviation 1.07
-1.1 Units on a scale
Standard Deviation 2.50
-1.2 Units on a scale
Standard Deviation 2.53
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-2.1 Units on a scale
Standard Deviation 2.49
-1.6 Units on a scale
Standard Deviation 2.22
-2.7 Units on a scale
Standard Deviation 1.73
-1.3 Units on a scale
Standard Deviation 1.04
-1.7 Units on a scale
Standard Deviation 2.52
-1.1 Units on a scale
Standard Deviation 3.00
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-2.1 Units on a scale
Standard Deviation 2.68
-1.3 Units on a scale
Standard Deviation 1.89
-3.1 Units on a scale
Standard Deviation 1.27
-0.3 Units on a scale
Standard Deviation 2.71
-1.8 Units on a scale
Standard Deviation 2.94
-1.2 Units on a scale
Standard Deviation 2.79
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-2.3 Units on a scale
Standard Deviation 2.66
-1.9 Units on a scale
Standard Deviation 2.29
-3.2 Units on a scale
Standard Deviation 3.03
-1.3 Units on a scale
Standard Deviation 0.89
-2.1 Units on a scale
Standard Deviation 2.24
-1.9 Units on a scale
Standard Deviation 2.71
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-2.4 Units on a scale
Standard Deviation 2.68
-2.3 Units on a scale
Standard Deviation 2.60
-3.8 Units on a scale
Standard Deviation 2.05
-1.4 Units on a scale
Standard Deviation 1.19
-2.5 Units on a scale
Standard Deviation 2.97
-3.1 Units on a scale
Standard Deviation 2.60
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-2.6 Units on a scale
Standard Deviation 2.70
-2.3 Units on a scale
Standard Deviation 2.28
-3.8 Units on a scale
Standard Deviation 2.79
-1.6 Units on a scale
Standard Deviation 1.06
-2.1 Units on a scale
Standard Deviation 2.51
-2.8 Units on a scale
Standard Deviation 2.60
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-2.9 Units on a scale
Standard Deviation 2.56
-2.4 Units on a scale
Standard Deviation 2.53
-3.3 Units on a scale
Standard Deviation 1.67
-1.6 Units on a scale
Standard Deviation 1.06
-2.1 Units on a scale
Standard Deviation 2.57
-3.2 Units on a scale
Standard Deviation 2.44
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-3.1 Units on a scale
Standard Deviation 2.55
-2.4 Units on a scale
Standard Deviation 2.34
-4.8 Units on a scale
Standard Deviation 2.76
-1.5 Units on a scale
Standard Deviation 0.76
-2.2 Units on a scale
Standard Deviation 1.74
-3.6 Units on a scale
Standard Deviation 2.59

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included all the participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline leeds enthesitis score\>0. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline leeds enthesitis score\>0.

The Leeds Enthesitis Index (LEI) examines tenderness at six sites: lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Each site is assessed as either tender (score=1) or not tender (score=0). The LEI scores range from 0-6, with higher scores indicating higher disease activity.

Outcome measures

Outcome measures
Measure
Placebo
n=29 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=28 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=10 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=8 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=20 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=15 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-1.3 Units on a scale
Standard Deviation 1.43
-1.2 Units on a scale
Standard Deviation 1.47
-0.5 Units on a scale
Standard Deviation 1.78
-0.4 Units on a scale
Standard Deviation 0.98
-0.5 Units on a scale
Standard Deviation 1.31
-0.7 Units on a scale
Standard Deviation 1.49
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-1.2 Units on a scale
Standard Deviation 1.93
-1.5 Units on a scale
Standard Deviation 1.42
-1.0 Units on a scale
Standard Deviation 1.22
-1.1 Units on a scale
Standard Deviation 0.90
-0.9 Units on a scale
Standard Deviation 0.94
-0.9 Units on a scale
Standard Deviation 1.79
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-0.4 Units on a scale
Standard Deviation 0.95
-0.4 Units on a scale
Standard Deviation 1.53
-0.5 Units on a scale
Standard Deviation 1.27
0.0 Units on a scale
Standard Deviation 0.53
-0.1 Units on a scale
Standard Deviation 1.12
-0.3 Units on a scale
Standard Deviation 0.82
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-0.7 Units on a scale
Standard Deviation 1.56
-0.9 Units on a scale
Standard Deviation 1.48
-1.0 Units on a scale
Standard Deviation 1.25
-0.1 Units on a scale
Standard Deviation 0.99
-0.4 Units on a scale
Standard Deviation 0.75
-0.9 Units on a scale
Standard Deviation 1.62
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-1.4 Units on a scale
Standard Deviation 1.63
-1.5 Units on a scale
Standard Deviation 1.45
-1.2 Units on a scale
Standard Deviation 0.83
-0.1 Units on a scale
Standard Deviation 2.12
-0.9 Units on a scale
Standard Deviation 1.13
-0.9 Units on a scale
Standard Deviation 1.54
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-1.6 Units on a scale
Standard Deviation 1.52
-1.3 Units on a scale
Standard Deviation 1.80
-1.7 Units on a scale
Standard Deviation 2.65
-0.9 Units on a scale
Standard Deviation 0.90
-1.1 Units on a scale
Standard Deviation 0.90
-1.4 Units on a scale
Standard Deviation 1.91
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-1.4 Units on a scale
Standard Deviation 1.56
-1.7 Units on a scale
Standard Deviation 1.57
-1.9 Units on a scale
Standard Deviation 2.20
-1.3 Units on a scale
Standard Deviation 0.76
-1.1 Units on a scale
Standard Deviation 1.20
-1.7 Units on a scale
Standard Deviation 1.54
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-1.9 Units on a scale
Standard Deviation 1.36
-1.8 Units on a scale
Standard Deviation 1.59
-2.3 Units on a scale
Standard Deviation 1.50
-1.1 Units on a scale
Standard Deviation 0.90
-1.1 Units on a scale
Standard Deviation 1.17
-1.7 Units on a scale
Standard Deviation 1.44
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-1.8 Units on a scale
Standard Deviation 1.47
-1.8 Units on a scale
Standard Deviation 1.65
-2.3 Units on a scale
Standard Deviation 1.04
-1.3 Units on a scale
Standard Deviation 0.76
-1.2 Units on a scale
Standard Deviation 1.19
-1.9 Units on a scale
Standard Deviation 1.41
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-2.0 Units on a scale
Standard Deviation 1.54
-1.7 Units on a scale
Standard Deviation 1.40
-2.5 Units on a scale
Standard Deviation 0.93
-1.0 Units on a scale
Standard Deviation 0.82
-1.2 Units on a scale
Standard Deviation 0.73
-1.8 Units on a scale
Standard Deviation 1.70

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included all the participants in evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline DSS \>0. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline DSS \>0.

The number of digits in hands and feet with dactylitis was evaluated by a blinded assessor. In addition, dactylitis severity was scored based upon digit tenderness using a scale of 0-3, where 0 = no tenderness to 3 = extreme tenderness, in each digit of the hands and feet. The range of total dactylitis scores was 0-60, with higher scores indicating greater severity. A negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=14 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=19 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=3 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=6 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=12 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=19 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-0.2 Units on a scale
Standard Deviation 2.36
-0.7 Units on a scale
Standard Deviation 2.54
-2.7 Units on a scale
Standard Deviation 4.62
-0.5 Units on a scale
Standard Deviation 1.38
-0.7 Units on a scale
Standard Deviation 1.61
0.2 Units on a scale
Standard Deviation 2.28
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-1.6 Units on a scale
Standard Deviation 3.30
-2.2 Units on a scale
Standard Deviation 3.15
-3.3 Units on a scale
Standard Deviation 3.21
-0.8 Units on a scale
Standard Deviation 1.17
-1.2 Units on a scale
Standard Deviation 2.59
-0.3 Units on a scale
Standard Deviation 3.12
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-3.5 Units on a scale
Standard Deviation 4.31
-4.0 Units on a scale
Standard Deviation 3.22
-4.3 Units on a scale
Standard Deviation 4.16
-1.7 Units on a scale
Standard Deviation 1.37
-2.5 Units on a scale
Standard Deviation 6.14
-1.8 Units on a scale
Standard Deviation 2.82
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-4.4 Units on a scale
Standard Deviation 3.34
-4.5 Units on a scale
Standard Deviation 3.30
-4.3 Units on a scale
Standard Deviation 4.93
-3.2 Units on a scale
Standard Deviation 3.43
-4.8 Units on a scale
Standard Deviation 7.07
-2.8 Units on a scale
Standard Deviation 4.49
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-3.7 Units on a scale
Standard Deviation 3.85
-4.9 Units on a scale
Standard Deviation 4.06
-4.7 Units on a scale
Standard Deviation 6.35
-3.7 Units on a scale
Standard Deviation 4.13
-5.4 Units on a scale
Standard Deviation 7.44
-2.9 Units on a scale
Standard Deviation 6.01
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-4.4 Units on a scale
Standard Deviation 3.31
-4.6 Units on a scale
Standard Deviation 4.23
-5.3 Units on a scale
Standard Deviation 5.86
-3.7 Units on a scale
Standard Deviation 4.13
-7.0 Units on a scale
Standard Deviation 7.44
-4.4 Units on a scale
Standard Deviation 6.11
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-3.8 Units on a scale
Standard Deviation 3.67
-5.1 Units on a scale
Standard Deviation 4.08
-5.3 Units on a scale
Standard Deviation 5.86
-3.7 Units on a scale
Standard Deviation 4.13
-6.6 Units on a scale
Standard Deviation 7.18
-4.7 Units on a scale
Standard Deviation 7.05
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-4.2 Units on a scale
Standard Deviation 4.02
-5.1 Units on a scale
Standard Deviation 4.26
-5.7 Units on a scale
Standard Deviation 5.69
-3.7 Units on a scale
Standard Deviation 4.13
-6.8 Units on a scale
Standard Deviation 7.34
-5.3 Units on a scale
Standard Deviation 7.40
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-5.0 Units on a scale
Standard Deviation 3.65
-5.4 Units on a scale
Standard Deviation 4.01
-5.7 Units on a scale
Standard Deviation 5.69
-3.7 Units on a scale
Standard Deviation 4.13
-6.8 Units on a scale
Standard Deviation 7.34
-5.3 Units on a scale
Standard Deviation 7.40
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-5.0 Units on a scale
Standard Deviation 3.65
-5.4 Units on a scale
Standard Deviation 4.05
-5.7 Units on a scale
Standard Deviation 5.69
-3.7 Units on a scale
Standard Deviation 4.13
-5.0 Units on a scale
Standard Deviation 5.40
-5.7 Units on a scale
Standard Deviation 8.62

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included all the participants in evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline NAPSI\>0. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline NAPSI\>0.

A target finger nail was evaluated by the blinded assessor using the NAPSI scale. At the baseline visit, the worst case fingernail was chosen and the same nail was evaluated consistently through the entire study. Each quadrant of the target nail was graded for nail matrix psoriasis (including any of the following parameters: pitting, leukonychia, red spots in lunula, nail plate crumbling) and nail bed psoriasis (including any of the following parameters: onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, nail bed hyperkeratosis). The target nail NAPSI scores range from 0 to 8, with higher scores indicating higher disease activity.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=40 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=10 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=8 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=25 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=16 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-0.4 Units on a scale
Standard Deviation 1.55
0.1 Units on a scale
Standard Deviation 0.65
-0.4 Units on a scale
Standard Deviation 0.52
0.3 Units on a scale
Standard Deviation 0.71
-0.2 Units on a scale
Standard Deviation 1.04
0.1 Units on a scale
Standard Deviation 0.25
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-1.0 Units on a scale
Standard Deviation 2.09
-0.5 Units on a scale
Standard Deviation 1.70
-0.9 Units on a scale
Standard Deviation 1.10
-0.3 Units on a scale
Standard Deviation 0.46
-1.0 Units on a scale
Standard Deviation 2.16
-0.3 Units on a scale
Standard Deviation 0.95
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-2.0 Units on a scale
Standard Deviation 2.40
-1.0 Units on a scale
Standard Deviation 1.49
-1.1 Units on a scale
Standard Deviation 1.52
-1.1 Units on a scale
Standard Deviation 1.57
-1.3 Units on a scale
Standard Deviation 2.55
-0.6 Units on a scale
Standard Deviation 1.55
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-2.8 Units on a scale
Standard Deviation 2.54
-1.8 Units on a scale
Standard Deviation 2.43
-0.5 Units on a scale
Standard Deviation 2.88
-1.9 Units on a scale
Standard Deviation 2.97
-1.2 Units on a scale
Standard Deviation 2.62
-1.3 Units on a scale
Standard Deviation 1.82
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-3.2 Units on a scale
Standard Deviation 2.71
-1.7 Units on a scale
Standard Deviation 2.54
-1.5 Units on a scale
Standard Deviation 2.00
-2.9 Units on a scale
Standard Deviation 3.08
-1.4 Units on a scale
Standard Deviation 2.61
-1.6 Units on a scale
Standard Deviation 1.76
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-3.7 Units on a scale
Standard Deviation 2.82
-2.3 Units on a scale
Standard Deviation 2.31
-2.1 Units on a scale
Standard Deviation 2.41
-3.1 Units on a scale
Standard Deviation 2.97
-2.0 Units on a scale
Standard Deviation 2.61
-1.9 Units on a scale
Standard Deviation 1.81
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-3.9 Units on a scale
Standard Deviation 2.90
-2.4 Units on a scale
Standard Deviation 2.56
-3.1 Units on a scale
Standard Deviation 2.12
-3.3 Units on a scale
Standard Deviation 2.93
-2.2 Units on a scale
Standard Deviation 2.59
-2.5 Units on a scale
Standard Deviation 1.83
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-3.9 Units on a scale
Standard Deviation 3.06
-2.5 Units on a scale
Standard Deviation 2.51
-3.3 Units on a scale
Standard Deviation 1.98
-3.3 Units on a scale
Standard Deviation 3.15
-2.8 Units on a scale
Standard Deviation 2.71
-2.9 Units on a scale
Standard Deviation 1.75
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-4.2 Units on a scale
Standard Deviation 2.77
-2.8 Units on a scale
Standard Deviation 2.47
-4.2 Units on a scale
Standard Deviation 2.05
-3.8 Units on a scale
Standard Deviation 3.19
-2.8 Units on a scale
Standard Deviation 2.61
-2.6 Units on a scale
Standard Deviation 1.71
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-4.2 Units on a scale
Standard Deviation 2.62
-2.6 Units on a scale
Standard Deviation 2.80
-3.6 Units on a scale
Standard Deviation 2.07
-3.7 Units on a scale
Standard Deviation 3.27
-3.1 Units on a scale
Standard Deviation 2.91
-2.7 Units on a scale
Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

Participant's perception of disease was assessed using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (excellent) and 100 (poor). The rating corresponded to the way in which the participant felt over the past week in terms of how they were affected by their: 1) psoriasis and arthritis (global, PGA); 2) arthritis only (PJA) and 3) psoriasis only (PSA). Rescaled VAS score was used. Rescaled VAS score (mm) = (100 mm) × (length at mark in mm/overall length of line in mm). A negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
-8.9 mm
Standard Deviation 26.88
-11.6 mm
Standard Deviation 22.31
-4.9 mm
Standard Deviation 12.42
-0.5 mm
Standard Deviation 12.41
-3.3 mm
Standard Deviation 14.50
-7.1 mm
Standard Deviation 17.44
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-17.0 mm
Standard Deviation 24.83
-18.8 mm
Standard Deviation 25.42
-13.2 mm
Standard Deviation 18.69
-7.1 mm
Standard Deviation 21.61
-11.6 mm
Standard Deviation 22.07
-6.2 mm
Standard Deviation 24.53
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-21.1 mm
Standard Deviation 26.95
-19.7 mm
Standard Deviation 27.56
-12.0 mm
Standard Deviation 26.52
-16.4 mm
Standard Deviation 25.36
-16.8 mm
Standard Deviation 26.21
-8.1 mm
Standard Deviation 24.41
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-25.1 mm
Standard Deviation 28.18
-25.3 mm
Standard Deviation 23.75
-18.0 mm
Standard Deviation 21.42
-17.6 mm
Standard Deviation 23.70
-14.4 mm
Standard Deviation 28.78
-9.5 mm
Standard Deviation 23.74
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-29.0 mm
Standard Deviation 24.78
-24.5 mm
Standard Deviation 25.43
-23.9 mm
Standard Deviation 21.10
-27.8 mm
Standard Deviation 21.23
-11.7 mm
Standard Deviation 23.36
-9.9 mm
Standard Deviation 23.87
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-29.1 mm
Standard Deviation 24.08
-30.5 mm
Standard Deviation 23.29
-27.3 mm
Standard Deviation 24.19
-22.6 mm
Standard Deviation 27.92
-36.3 mm
Standard Deviation 22.12
-26.3 mm
Standard Deviation 29.72
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-30.0 mm
Standard Deviation 24.53
-29.7 mm
Standard Deviation 28.36
-37.2 mm
Standard Deviation 22.80
-38.8 mm
Standard Deviation 25.73
-37.3 mm
Standard Deviation 25.35
-37.2 mm
Standard Deviation 24.64
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-29.1 mm
Standard Deviation 27.81
-29.6 mm
Standard Deviation 27.90
-42.0 mm
Standard Deviation 26.37
-33.7 mm
Standard Deviation 27.04
-36.0 mm
Standard Deviation 22.02
-39.4 mm
Standard Deviation 26.35
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-33.6 mm
Standard Deviation 28.52
-32.4 mm
Standard Deviation 28.81
-41.9 mm
Standard Deviation 19.08
-36.8 mm
Standard Deviation 30.62
-38.2 mm
Standard Deviation 26.65
-42.1 mm
Standard Deviation 27.08
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-33.3 mm
Standard Deviation 28.68
-32.7 mm
Standard Deviation 29.77
-35.6 mm
Standard Deviation 26.94
-33.9 mm
Standard Deviation 33.45
-39.1 mm
Standard Deviation 23.78
-38.3 mm
Standard Deviation 30.58

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

The FACIT-F Scale is a patient completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 2
2.0 Units on a scale
Standard Deviation 5.82
3.1 Units on a scale
Standard Deviation 5.85
0.9 Units on a scale
Standard Deviation 2.60
1.2 Units on a scale
Standard Deviation 6.45
0.9 Units on a scale
Standard Deviation 6.95
2.7 Units on a scale
Standard Deviation 6.07
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
2.4 Units on a scale
Standard Deviation 7.47
5.7 Units on a scale
Standard Deviation 7.34
3.7 Units on a scale
Standard Deviation 5.40
3.7 Units on a scale
Standard Deviation 8.30
3.0 Units on a scale
Standard Deviation 10.76
2.5 Units on a scale
Standard Deviation 6.98
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
4.2 Units on a scale
Standard Deviation 8.03
5.6 Units on a scale
Standard Deviation 8.44
3.6 Units on a scale
Standard Deviation 5.78
3.8 Units on a scale
Standard Deviation 6.24
3.2 Units on a scale
Standard Deviation 10.31
3.7 Units on a scale
Standard Deviation 9.92
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
4.7 Units on a scale
Standard Deviation 10.17
7.3 Units on a scale
Standard Deviation 7.96
3.2 Units on a scale
Standard Deviation 4.10
6.1 Units on a scale
Standard Deviation 7.85
5.5 Units on a scale
Standard Deviation 9.55
3.8 Units on a scale
Standard Deviation 9.85
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
5.6 Units on a scale
Standard Deviation 7.74
7.1 Units on a scale
Standard Deviation 9.41
4.4 Units on a scale
Standard Deviation 5.40
6.0 Units on a scale
Standard Deviation 6.89
4.7 Units on a scale
Standard Deviation 8.10
4.7 Units on a scale
Standard Deviation 8.99
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
6.6 Units on a scale
Standard Deviation 8.69
9.5 Units on a scale
Standard Deviation 8.20
7.2 Units on a scale
Standard Deviation 5.86
7.0 Units on a scale
Standard Deviation 7.94
8.9 Units on a scale
Standard Deviation 8.11
9.3 Units on a scale
Standard Deviation 9.20
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
7.7 Units on a scale
Standard Deviation 9.67
9.5 Units on a scale
Standard Deviation 8.22
7.2 Units on a scale
Standard Deviation 7.73
12.3 Units on a scale
Standard Deviation 11.48
9.8 Units on a scale
Standard Deviation 10.02
11.7 Units on a scale
Standard Deviation 10.41
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
7.4 Units on a scale
Standard Deviation 9.51
8.4 Units on a scale
Standard Deviation 8.25
7.3 Units on a scale
Standard Deviation 5.54
10.6 Units on a scale
Standard Deviation 11.36
9.6 Units on a scale
Standard Deviation 6.48
11.3 Units on a scale
Standard Deviation 11.23
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
7.8 Units on a scale
Standard Deviation 9.00
10.0 Units on a scale
Standard Deviation 9.52
7.9 Units on a scale
Standard Deviation 5.07
13.1 Units on a scale
Standard Deviation 11.10
7.7 Units on a scale
Standard Deviation 7.89
11.8 Units on a scale
Standard Deviation 11.35
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
7.8 Units on a scale
Standard Deviation 8.54
10.4 Units on a scale
Standard Deviation 9.86
9.4 Units on a scale
Standard Deviation 9.01
12.3 Units on a scale
Standard Deviation 12.74
10.5 Units on a scale
Standard Deviation 8.91
10.5 Units on a scale
Standard Deviation 10.62

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). These 8 domains can also be summarized as physical and mental component scores. The summary component scores, Physical Component Summary (PCS) and Mental Component Summary (MCS), are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH. All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The minimum and maximum scores of the PCS Score are 22 and 59 respectively. The minimum and maximum scores of the MCS Score are 11 and 62 respectively.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4 (Physical Component Summary Score)
3.29 Units on a scale
Standard Deviation 7.092
4.24 Units on a scale
Standard Deviation 7.602
2.59 Units on a scale
Standard Deviation 5.263
1.01 Units on a scale
Standard Deviation 3.944
1.66 Units on a scale
Standard Deviation 5.845
2.64 Units on a scale
Standard Deviation 6.299
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8 (Physical Component Summary Score)
4.21 Units on a scale
Standard Deviation 8.297
5.97 Units on a scale
Standard Deviation 8.261
5.53 Units on a scale
Standard Deviation 9.387
2.47 Units on a scale
Standard Deviation 3.675
2.57 Units on a scale
Standard Deviation 6.457
3.04 Units on a scale
Standard Deviation 5.529
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12 (Physical Component Summary Score)
4.09 Units on a scale
Standard Deviation 8.403
4.86 Units on a scale
Standard Deviation 9.010
7.28 Units on a scale
Standard Deviation 7.232
2.29 Units on a scale
Standard Deviation 4.283
2.22 Units on a scale
Standard Deviation 6.205
3.07 Units on a scale
Standard Deviation 7.330
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16 (Physical Component Summary Score)
5.40 Units on a scale
Standard Deviation 8.239
7.27 Units on a scale
Standard Deviation 8.627
6.97 Units on a scale
Standard Deviation 7.223
5.07 Units on a scale
Standard Deviation 4.763
2.36 Units on a scale
Standard Deviation 6.842
1.79 Units on a scale
Standard Deviation 6.101
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20 (Physical Component Summary Score)
4.75 Units on a scale
Standard Deviation 8.579
8.84 Units on a scale
Standard Deviation 8.231
9.53 Units on a scale
Standard Deviation 8.434
2.03 Units on a scale
Standard Deviation 6.756
6.14 Units on a scale
Standard Deviation 7.513
6.25 Units on a scale
Standard Deviation 8.447
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28 (Physical Component Summary Score)
6.16 Units on a scale
Standard Deviation 8.691
9.06 Units on a scale
Standard Deviation 9.597
9.42 Units on a scale
Standard Deviation 7.751
7.84 Units on a scale
Standard Deviation 7.127
5.67 Units on a scale
Standard Deviation 7.933
9.22 Units on a scale
Standard Deviation 8.890
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36 (Physical Component Summary Score)
6.58 Units on a scale
Standard Deviation 9.510
7.75 Units on a scale
Standard Deviation 9.223
9.08 Units on a scale
Standard Deviation 9.789
6.44 Units on a scale
Standard Deviation 7.245
5.96 Units on a scale
Standard Deviation 6.738
9.41 Units on a scale
Standard Deviation 8.940
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44 (Physical Component Summary Score)
6.67 Units on a scale
Standard Deviation 9.541
9.23 Units on a scale
Standard Deviation 9.477
8.44 Units on a scale
Standard Deviation 9.527
7.13 Units on a scale
Standard Deviation 6.759
6.00 Units on a scale
Standard Deviation 6.937
9.18 Units on a scale
Standard Deviation 8.199
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52 (Physical Component Summary Score)
6.52 Units on a scale
Standard Deviation 9.818
9.98 Units on a scale
Standard Deviation 9.150
9.55 Units on a scale
Standard Deviation 9.536
6.64 Units on a scale
Standard Deviation 7.925
7.21 Units on a scale
Standard Deviation 8.130
9.84 Units on a scale
Standard Deviation 9.347
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4 (Mental Component Summary Score)
-0.28 Units on a scale
Standard Deviation 10.643
3.79 Units on a scale
Standard Deviation 9.139
1.24 Units on a scale
Standard Deviation 5.426
3.99 Units on a scale
Standard Deviation 10.723
0.45 Units on a scale
Standard Deviation 7.539
-1.09 Units on a scale
Standard Deviation 9.805
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8 (Mental Component Summary Score)
0.84 Units on a scale
Standard Deviation 9.810
2.84 Units on a scale
Standard Deviation 10.894
-2.05 Units on a scale
Standard Deviation 10.553
6.91 Units on a scale
Standard Deviation 10.450
0.29 Units on a scale
Standard Deviation 10.253
0.75 Units on a scale
Standard Deviation 8.880
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12 (Mental Component Summary Score)
0.85 Units on a scale
Standard Deviation 9.860
4.99 Units on a scale
Standard Deviation 10.307
0.78 Units on a scale
Standard Deviation 8.488
5.15 Units on a scale
Standard Deviation 13.189
1.37 Units on a scale
Standard Deviation 11.261
1.50 Units on a scale
Standard Deviation 9.640
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16 (Mental Component Summary Score)
2.25 Units on a scale
Standard Deviation 10.848
2.12 Units on a scale
Standard Deviation 11.369
1.01 Units on a scale
Standard Deviation 6.995
4.78 Units on a scale
Standard Deviation 10.930
2.83 Units on a scale
Standard Deviation 8.459
3.03 Units on a scale
Standard Deviation 9.824
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20 (Mental Component Summary Score)
2.44 Units on a scale
Standard Deviation 10.131
3.59 Units on a scale
Standard Deviation 10.763
2.76 Units on a scale
Standard Deviation 8.595
6.58 Units on a scale
Standard Deviation 10.796
4.99 Units on a scale
Standard Deviation 8.782
6.72 Units on a scale
Standard Deviation 8.781
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28 (Mental Component Summary Score)
3.85 Units on a scale
Standard Deviation 11.295
3.64 Units on a scale
Standard Deviation 11.004
3.54 Units on a scale
Standard Deviation 7.290
8.95 Units on a scale
Standard Deviation 12.914
6.08 Units on a scale
Standard Deviation 7.764
6.57 Units on a scale
Standard Deviation 9.590
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36 (Mental Component Summary Score)
3.98 Units on a scale
Standard Deviation 9.044
5.41 Units on a scale
Standard Deviation 11.649
4.74 Units on a scale
Standard Deviation 9.301
8.53 Units on a scale
Standard Deviation 14.210
6.58 Units on a scale
Standard Deviation 7.419
5.47 Units on a scale
Standard Deviation 10.182
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44 (Mental Component Summary Score)
5.14 Units on a scale
Standard Deviation 9.745
4.43 Units on a scale
Standard Deviation 13.601
4.29 Units on a scale
Standard Deviation 10.641
7.70 Units on a scale
Standard Deviation 13.606
6.33 Units on a scale
Standard Deviation 7.785
4.98 Units on a scale
Standard Deviation 10.544
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52 (Mental Component Summary Score)
4.12 Units on a scale
Standard Deviation 10.023
4.33 Units on a scale
Standard Deviation 13.303
3.63 Units on a scale
Standard Deviation 10.656
8.69 Units on a scale
Standard Deviation 16.192
5.68 Units on a scale
Standard Deviation 8.783
4.35 Units on a scale
Standard Deviation 10.770

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

A psoriatic arthritis participant was defined as having MDA response when 5 of the 7 following criteria were met: 1) tender joint count ≤1; 2) swollen joint count ≤1; 3) Psoriasis Area and Severity Index (quantifying the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area affected) score ≤1 or Body Surface Area (assessment of body surface area involved in psoriasis) ≤3%; 4) Patient's Assessment of Arthritis Pain (assessment of the patient's level of pain using a horizontal 100 mm visual analog scale) ≤15 mm; 5) Patient's Global Arthritis Assessment (patient's overall assessment of how the arthritis was doing by a 100 mm visual analog scale) ≤20 mm; 6) Health Assessment Questionnaire - Disability Index (assessment of the degree of difficulty a patient experienced) score ≤0.5; 7) tender entheseal points (assessment of tenderness using Leed's Enthesitis Index) ≤1.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
8.33 Percentage of participants
Interval 1.34 to 15.33
8.33 Percentage of participants
Interval 1.34 to 15.33
6.25 Percentage of participants
Interval 0.0 to 18.11
3.13 Percentage of participants
Interval 0.0 to 11.65
1.43 Percentage of participants
Interval 0.0 to 5.36
3.03 Percentage of participants
Interval 0.0 to 8.88
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
26.67 Percentage of participants
Interval 15.48 to 37.86
21.67 Percentage of participants
Interval 11.24 to 32.09
18.75 Percentage of participants
Interval 0.0 to 37.87
6.67 Percentage of participants
Interval 0.0 to 19.29
5.88 Percentage of participants
Interval 0.0 to 13.79
12.12 Percentage of participants
Interval 0.99 to 23.26
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
31.67 Percentage of participants
Interval 19.9 to 43.44
25.00 Percentage of participants
Interval 14.04 to 35.96
18.75 Percentage of participants
Interval 0.0 to 37.87
20.00 Percentage of participants
Interval 0.0 to 40.24
5.88 Percentage of participants
Interval 0.0 to 13.79
12.12 Percentage of participants
Interval 0.99 to 23.26
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
35.59 Percentage of participants
Interval 23.38 to 47.81
35.00 Percentage of participants
Interval 22.93 to 47.07
18.75 Percentage of participants
Interval 0.0 to 37.87
20.00 Percentage of participants
Interval 0.0 to 40.24
2.94 Percentage of participants
Interval 0.0 to 8.62
3.03 Percentage of participants
Interval 0.0 to 8.88
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
45.00 Percentage of participants
Interval 32.41 to 57.59
38.33 Percentage of participants
Interval 26.03 to 50.64
25.00 Percentage of participants
Interval 3.78 to 46.22
26.67 Percentage of participants
Interval 4.29 to 49.05
29.41 Percentage of participants
Interval 14.1 to 44.73
24.24 Percentage of participants
Interval 9.62 to 38.86
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
43.33 Percentage of participants
Interval 30.79 to 55.87
46.67 Percentage of participants
Interval 34.04 to 59.29
31.25 Percentage of participants
Interval 8.54 to 53.96
33.33 Percentage of participants
Interval 9.48 to 57.19
32.35 Percentage of participants
Interval 16.63 to 48.08
45.45 Percentage of participants
Interval 28.47 to 62.44
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
43.33 Percentage of participants
Interval 30.79 to 55.87
43.33 Percentage of participants
Interval 30.79 to 55.87
50.00 Percentage of participants
Interval 25.5 to 74.5
60.00 Percentage of participants
Interval 35.21 to 84.79
29.41 Percentage of participants
Interval 14.1 to 44.73
57.58 Percentage of participants
Interval 40.71 to 74.44
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
53.33 Percentage of participants
Interval 40.71 to 65.96
50.00 Percentage of participants
Interval 37.35 to 62.65
31.25 Percentage of participants
Interval 8.54 to 53.96
46.67 Percentage of participants
Interval 21.42 to 71.91
32.35 Percentage of participants
Interval 16.63 to 48.08
51.52 Percentage of participants
Interval 34.46 to 68.57
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
46.67 Percentage of participants
Interval 34.04 to 59.29
48.33 Percentage of participants
Interval 35.69 to 60.98
31.25 Percentage of participants
Interval 8.54 to 53.96
40.00 Percentage of participants
Interval 15.21 to 64.79
41.18 Percentage of participants
Interval 24.63 to 57.72
45.45 Percentage of participants
Interval 28.47 to 62.44

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.

A participant was in VLDA when all the 7 following criteria were met: 1) tender joint count ≤1; 2) swollen joint count ≤1; 3) Psoriasis Area and Severity Index (quantifying the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area affected) score ≤1 or Body Surface Area (assessment of body surface area involved in psoriasis) ≤3%; 4) Patient's Assessment of Arthritis Pain (assessment of the patient's level of pain using a horizontal 100 mm visual analog scale) ≤15 mm; 5) Patient's Global Arthritis Assessment (patient's overall assessment of how the arthritis was doing by a 100 mm visual analog scale) ≤20 mm; 6) Health Assessment Questionnaire - Disability Index (assessment of the degree of difficulty a patient experienced) score ≤0.5; 7) tender entheseal points (assessment of tenderness using Leed's Enthesitis Index) ≤1.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
0.82 Percentage of participants
Interval 0.0 to 3.08
0.82 Percentage of participants
Interval 0.0 to 3.08
2.94 Percentage of participants
Interval 0.0 to 10.97
3.13 Percentage of participants
Interval 0.0 to 11.65
1.43 Percentage of participants
Interval 0.0 to 5.36
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
1.67 Percentage of participants
Interval 0.0 to 4.91
1.67 Percentage of participants
Interval 0.0 to 4.91
2.94 Percentage of participants
Interval 0.0 to 10.97
3.13 Percentage of participants
Interval 0.0 to 11.65
1.43 Percentage of participants
Interval 0.0 to 5.36
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
0.82 Percentage of participants
Interval 0.0 to 3.08
3.33 Percentage of participants
Interval 0.0 to 7.88
2.94 Percentage of participants
Interval 0.0 to 10.97
3.13 Percentage of participants
Interval 0.0 to 11.65
1.43 Percentage of participants
Interval 0.0 to 5.36
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
3.39 Percentage of participants
Interval 0.0 to 8.01
5.00 Percentage of participants
Interval 0.0 to 10.51
6.25 Percentage of participants
Interval 0.0 to 18.11
3.13 Percentage of participants
Interval 0.0 to 11.65
1.43 Percentage of participants
Interval 0.0 to 5.36
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
6.67 Percentage of participants
Interval 0.35 to 12.98
11.67 Percentage of participants
Interval 3.54 to 19.79
12.50 Percentage of participants
Interval 0.0 to 28.7
13.33 Percentage of participants
Interval 0.0 to 30.54
2.94 Percentage of participants
Interval 0.0 to 8.62
1.47 Percentage of participants
Interval 0.0 to 5.52
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
10.00 Percentage of participants
Interval 2.41 to 17.59
10.00 Percentage of participants
Interval 2.41 to 17.59
12.50 Percentage of participants
Interval 0.0 to 28.7
6.67 Percentage of participants
Interval 0.0 to 19.29
8.82 Percentage of participants
Interval 0.0 to 18.36
6.06 Percentage of participants
Interval 0.0 to 14.2
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
15.00 Percentage of participants
Interval 5.97 to 24.03
15.00 Percentage of participants
Interval 5.97 to 24.03
12.50 Percentage of participants
Interval 0.0 to 28.7
6.67 Percentage of participants
Interval 0.0 to 19.29
5.88 Percentage of participants
Interval 0.0 to 13.79
12.12 Percentage of participants
Interval 0.99 to 23.26
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
15.00 Percentage of participants
Interval 5.97 to 24.03
16.67 Percentage of participants
Interval 7.24 to 26.1
18.75 Percentage of participants
Interval 0.0 to 37.87
20.00 Percentage of participants
Interval 0.0 to 40.24
14.71 Percentage of participants
Interval 2.8 to 26.61
15.15 Percentage of participants
Interval 2.92 to 27.38
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
20.00 Percentage of participants
Interval 9.88 to 30.12
16.67 Percentage of participants
Interval 7.24 to 26.1
25.00 Percentage of participants
Interval 3.78 to 46.22
20.00 Percentage of participants
Interval 0.0 to 40.24
11.76 Percentage of participants
Interval 0.93 to 22.59
18.18 Percentage of participants
Interval 5.02 to 31.34

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" included all the participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline DAREA/DAPSA. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline DAREA/DAPSA.

DAREA/DAPSA is a composite instrument to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender/painful joint count + swollen joint count (using SJC66/ TJC68 assessments), Patient's Global Assessment of Arthritis (PtGA in cm), Patient's Assessment of Arthritis Pain (PAIN in cm) and C-reactive protein (CRP) (in mg/dL). Since DAREA reflects domains found important in PsA, it has been proposed to serve as a Disease Activity Index for Psoriatic Arthritis (DAPSA). DAREA/DAPSA was calculated as follows: DAREA/DAPSA= SJC66 + TJC68 + PtGA + PAIN + CRP. A negative change from baseline represents improvement.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-26.75 Units on a scale
Standard Deviation 13.625
-25.24 Units on a scale
Standard Deviation 12.152
-30.63 Units on a scale
Standard Deviation 17.150
-27.01 Units on a scale
Standard Deviation 22.334
-23.53 Units on a scale
Standard Deviation 13.606
-23.63 Units on a scale
Standard Deviation 13.640
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-27.13 Units on a scale
Standard Deviation 12.807
-25.38 Units on a scale
Standard Deviation 13.129
-32.63 Units on a scale
Standard Deviation 18.437
-31.41 Units on a scale
Standard Deviation 22.145
-23.54 Units on a scale
Standard Deviation 12.375
-27.55 Units on a scale
Standard Deviation 14.831
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-27.21 Units on a scale
Standard Deviation 14.456
-25.84 Units on a scale
Standard Deviation 13.170
-34.98 Units on a scale
Standard Deviation 19.857
-31.53 Units on a scale
Standard Deviation 24.046
-25.57 Units on a scale
Standard Deviation 11.445
-28.22 Units on a scale
Standard Deviation 15.793
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-28.39 Units on a scale
Standard Deviation 14.445
-27.54 Units on a scale
Standard Deviation 12.744
-36.61 Units on a scale
Standard Deviation 14.597
-30.22 Units on a scale
Standard Deviation 27.532
-26.43 Units on a scale
Standard Deviation 10.880
-29.59 Units on a scale
Standard Deviation 15.962
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-28.56 Units on a scale
Standard Deviation 15.578
-27.40 Units on a scale
Standard Deviation 13.429
-37.81 Units on a scale
Standard Deviation 14.251
-30.32 Units on a scale
Standard Deviation 22.795
-26.45 Units on a scale
Standard Deviation 11.114
-28.95 Units on a scale
Standard Deviation 17.706
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-14.05 Units on a scale
Standard Deviation 11.826
-13.99 Units on a scale
Standard Deviation 10.166
-14.15 Units on a scale
Standard Deviation 14.294
-9.81 Units on a scale
Standard Deviation 13.841
-7.11 Units on a scale
Standard Deviation 8.738
-9.08 Units on a scale
Standard Deviation 12.074
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-20.36 Units on a scale
Standard Deviation 11.211
-17.55 Units on a scale
Standard Deviation 11.664
-19.19 Units on a scale
Standard Deviation 11.720
-14.33 Units on a scale
Standard Deviation 15.143
-12.46 Units on a scale
Standard Deviation 12.905
-10.98 Units on a scale
Standard Deviation 15.222
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-21.93 Units on a scale
Standard Deviation 12.582
-20.91 Units on a scale
Standard Deviation 11.985
-24.91 Units on a scale
Standard Deviation 15.556
-17.77 Units on a scale
Standard Deviation 18.471
-14.68 Units on a scale
Standard Deviation 12.943
-13.04 Units on a scale
Standard Deviation 15.072
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-25.15 Units on a scale
Standard Deviation 12.582
-23.55 Units on a scale
Standard Deviation 12.040
-26.65 Units on a scale
Standard Deviation 16.982
-25.89 Units on a scale
Standard Deviation 18.513
-15.83 Units on a scale
Standard Deviation 12.918
-14.45 Units on a scale
Standard Deviation 15.150

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints.

The PsARC response was defined as improvement in two of the following 4 criteria, one of which must be joint pain or swelling, without worsening in any measure: (1) ≥20% improvement in Physician's Global Assessment of Arthritis (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity); (2) ≥20% improvement in Patient's Global Assessment of Arthritis (the patient's overall assessment of how the arthritis was doing by a visual analog scale); (3) ≥30% improvement in tender joint count (68); and (4) ≥30% improvement in swollen joint count.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
66.67 Percentage of participants
Interval 54.74 to 78.59
75.00 Percentage of participants
Interval 64.04 to 85.96
62.50 Percentage of participants
Interval 38.78 to 86.22
60.00 Percentage of participants
Interval 35.21 to 84.79
52.94 Percentage of participants
Interval 36.16 to 69.72
45.45 Percentage of participants
Interval 28.47 to 62.44
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
50.00 Percentage of participants
Interval 37.35 to 62.65
55.00 Percentage of participants
Interval 42.41 to 67.59
50.00 Percentage of participants
Interval 25.5 to 74.5
40.00 Percentage of participants
Interval 15.21 to 64.79
26.47 Percentage of participants
Interval 11.64 to 41.3
21.21 Percentage of participants
Interval 7.26 to 35.16
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
66.67 Percentage of participants
Interval 54.74 to 78.59
60.00 Percentage of participants
Interval 47.6 to 72.4
56.25 Percentage of participants
Interval 31.94 to 80.56
40.00 Percentage of participants
Interval 15.21 to 64.79
38.24 Percentage of participants
Interval 21.9 to 54.57
45.45 Percentage of participants
Interval 28.47 to 62.44
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
83.05 Percentage of participants
Interval 73.48 to 92.62
75.00 Percentage of participants
Interval 64.04 to 85.96
62.50 Percentage of participants
Interval 38.78 to 86.22
66.67 Percentage of participants
Interval 42.81 to 90.52
50.00 Percentage of participants
Interval 33.19 to 66.81
48.48 Percentage of participants
Interval 31.43 to 65.54
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
78.33 Percentage of participants
Interval 67.91 to 88.76
81.67 Percentage of participants
Interval 71.88 to 91.46
56.25 Percentage of participants
Interval 31.94 to 80.56
60.00 Percentage of participants
Interval 35.21 to 84.79
70.59 Percentage of participants
Interval 55.27 to 85.9
72.73 Percentage of participants
Interval 57.53 to 87.92
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
81.67 Percentage of participants
Interval 71.88 to 91.46
80.00 Percentage of participants
Interval 69.88 to 90.12
68.75 Percentage of participants
Interval 46.04 to 91.46
73.33 Percentage of participants
Interval 50.95 to 95.71
73.53 Percentage of participants
Interval 58.7 to 88.36
75.76 Percentage of participants
Interval 61.14 to 90.38
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
66.67 Percentage of participants
Interval 54.74 to 78.59
75.00 Percentage of participants
Interval 64.04 to 85.96
68.75 Percentage of participants
Interval 46.04 to 91.46
80.00 Percentage of participants
Interval 59.76 to 100.0
67.65 Percentage of participants
Interval 51.92 to 83.37
84.85 Percentage of participants
Interval 72.62 to 97.08
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
66.67 Percentage of participants
Interval 54.74 to 78.59
78.33 Percentage of participants
Interval 67.91 to 88.76
56.25 Percentage of participants
Interval 31.94 to 80.56
73.33 Percentage of participants
Interval 50.95 to 95.71
58.82 Percentage of participants
Interval 42.28 to 75.37
75.76 Percentage of participants
Interval 61.14 to 90.38
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
58.33 Percentage of participants
Interval 45.86 to 70.81
70.00 Percentage of participants
Interval 58.4 to 81.6
56.25 Percentage of participants
Interval 31.94 to 80.56
66.67 Percentage of participants
Interval 42.81 to 90.52
64.71 Percentage of participants
Interval 48.64 to 80.77
66.67 Percentage of participants
Interval 50.58 to 82.75

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52

Population: "Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints.

PASDAS is a composite psoriatic arthritis disease activity score that includes the following components: patient's global joint and skin assessment (visual analog scale in mm), physician's global psoriatic arthritis assessment (visual analog scale in mm), swollen (66 joints) and tender joint counts (68 joints), Leeds Enthesitis Index score, tender dactylitic digit score, physical component summary score (PCS) of Short Form 36 Health Survey and C-reactive protein (mg/L). Any missing component would result in PASDAS as missing. A higher PASDAS score indicates a higher disease activity.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 4
-1.22 Units on a scale
Standard Deviation 1.119
-1.31 Units on a scale
Standard Deviation 1.090
-0.94 Units on a scale
Standard Deviation 0.957
-0.65 Units on a scale
Standard Deviation 0.653
-0.56 Units on a scale
Standard Deviation 0.655
-0.54 Units on a scale
Standard Deviation 0.897
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 8
-1.79 Units on a scale
Standard Deviation 1.295
-1.65 Units on a scale
Standard Deviation 1.262
-1.37 Units on a scale
Standard Deviation 1.127
-1.14 Units on a scale
Standard Deviation 1.122
-1.02 Units on a scale
Standard Deviation 0.988
-0.67 Units on a scale
Standard Deviation 1.045
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 12
-2.10 Units on a scale
Standard Deviation 1.380
-1.93 Units on a scale
Standard Deviation 1.278
-1.67 Units on a scale
Standard Deviation 0.996
-1.61 Units on a scale
Standard Deviation 1.106
-1.04 Units on a scale
Standard Deviation 1.101
-0.80 Units on a scale
Standard Deviation 1.158
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 16
-2.31 Units on a scale
Standard Deviation 1.302
-2.20 Units on a scale
Standard Deviation 1.354
-1.87 Units on a scale
Standard Deviation 1.024
-2.18 Units on a scale
Standard Deviation 1.286
-1.08 Units on a scale
Standard Deviation 1.127
-0.90 Units on a scale
Standard Deviation 1.193
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 20
-2.48 Units on a scale
Standard Deviation 1.338
-2.48 Units on a scale
Standard Deviation 1.474
-2.49 Units on a scale
Standard Deviation 1.199
-2.18 Units on a scale
Standard Deviation 1.441
-2.37 Units on a scale
Standard Deviation 1.202
-2.10 Units on a scale
Standard Deviation 1.367
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 28
-2.62 Units on a scale
Standard Deviation 1.354
-2.60 Units on a scale
Standard Deviation 1.642
-2.90 Units on a scale
Standard Deviation 1.279
-3.18 Units on a scale
Standard Deviation 1.484
-2.48 Units on a scale
Standard Deviation 1.181
-2.81 Units on a scale
Standard Deviation 1.302
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 36
-2.73 Units on a scale
Standard Deviation 1.509
-2.59 Units on a scale
Standard Deviation 1.644
-3.08 Units on a scale
Standard Deviation 1.539
-2.97 Units on a scale
Standard Deviation 1.550
-2.69 Units on a scale
Standard Deviation 1.043
-2.96 Units on a scale
Standard Deviation 1.425
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 44
-2.95 Units on a scale
Standard Deviation 1.421
-2.85 Units on a scale
Standard Deviation 1.637
-3.25 Units on a scale
Standard Deviation 0.819
-3.23 Units on a scale
Standard Deviation 1.833
-2.73 Units on a scale
Standard Deviation 1.157
-3.23 Units on a scale
Standard Deviation 1.508
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Week 52
-3.03 Units on a scale
Standard Deviation 1.487
-2.98 Units on a scale
Standard Deviation 1.568
-3.36 Units on a scale
Standard Deviation 0.826
-3.14 Units on a scale
Standard Deviation 1.461
-2.84 Units on a scale
Standard Deviation 1.399
-3.07 Units on a scale
Standard Deviation 1.775

SECONDARY outcome

Timeframe: Baseline (Day 1) through Week 56

Population: All participants who received at least one dose of the randomized study treatment.

Treatment-emergent AEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the participant or may require intervention to prevent one of the other AE outcomes. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
Participants with AEs
46 Participants
45 Participants
10 Participants
10 Participants
24 Participants
25 Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
Participants with SAEs
1 Participants
8 Participants
0 Participants
0 Participants
1 Participants
2 Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
Participants with severe AEs
1 Participants
6 Participants
0 Participants
0 Participants
1 Participants
2 Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
Participants with dose reduction or temporary discontinuation due to AEs
18 Participants
14 Participants
4 Participants
3 Participants
4 Participants
8 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) through Week 56

Population: All participants who received at least one dose of the randomized study treatment.

Treatment-emergent AEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the participant or may require intervention to prevent one of the other AE outcomes. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment. Treatment-related AEs were also determined by the investigator.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
Participants with AEs
17 Participants
15 Participants
6 Participants
2 Participants
11 Participants
10 Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
Participants with SAEs
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
Participants with severe AEs
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
Participants with dose reduction or temporary discontinuation due to AEs
8 Participants
5 Participants
4 Participants
1 Participants
1 Participants
3 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) through Week 56

Population: All participants who received at least one dose of the randomized study treatment.

An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of the study medication.

Outcome measures

Outcome measures
Measure
Placebo
n=60 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16).
PF-06700841 10 mg QD
n=60 Participants
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 30 mg QD
n=16 Participants
PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16).
PF-06700841 60 mg QD
n=15 Participants
PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Placebo -> PF-06700841 60 mg QD
n=34 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 Participants
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56
Otitis media acute
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56
Upper respiratory tract infection
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56
Psoriasis
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants

Adverse Events

PF-06700841 60 mg QD -> PF-06700841 60 mg QD

Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths

PF-06700841 30 mg QD -> PF-06700841 30 mg QD

Serious events: 8 serious events
Other events: 34 other events
Deaths: 0 deaths

PF-06700841 10 mg QD -> PF-06700841 60 mg QD

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

PF-06700841 10 mg QD -> PF-06700841 30 mg QD

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Placebo -> PF-06700841 60 mg QD

Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths

Placebo -> PF-06700841 30 mg QD

Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
PF-06700841 60 mg QD -> PF-06700841 60 mg QD
n=60 participants at risk
PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 30 mg QD -> PF-06700841 30 mg QD
n=60 participants at risk
PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 10 mg QD -> PF-06700841 60 mg QD
n=16 participants at risk
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.
PF-06700841 10 mg QD -> PF-06700841 30 mg QD
n=15 participants at risk
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 60 mg QD
n=34 participants at risk
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 participants at risk
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Gastrointestinal disorders
Duodenal ulcer
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Hepatobiliary disorders
Cholecystitis chronic
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Appendicitis
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
COVID-19 pneumonia
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Otitis media acute
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Pneumonia
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Pneumonia viral
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Varicella
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Injury, poisoning and procedural complications
Radius fracture
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Musculoskeletal and connective tissue disorders
Synovitis
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Nervous system disorders
Lumbar radiculopathy
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Nervous system disorders
Neuralgia
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Nervous system disorders
Vascular encephalopathy
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.

Other adverse events

Other adverse events
Measure
PF-06700841 60 mg QD -> PF-06700841 60 mg QD
n=60 participants at risk
PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 30 mg QD -> PF-06700841 30 mg QD
n=60 participants at risk
PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52).
PF-06700841 10 mg QD -> PF-06700841 60 mg QD
n=16 participants at risk
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.
PF-06700841 10 mg QD -> PF-06700841 30 mg QD
n=15 participants at risk
PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 60 mg QD
n=34 participants at risk
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52).
Placebo -> PF-06700841 30 mg QD
n=33 participants at risk
Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Blood and lymphatic system disorders
Anaemia
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
8.8%
3/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Blood and lymphatic system disorders
Leukopenia
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Blood and lymphatic system disorders
Neutropenia
5.0%
3/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Gastrointestinal disorders
Abdominal pain upper
6.7%
4/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Gastrointestinal disorders
Aphthous ulcer
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Gastrointestinal disorders
Constipation
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Gastrointestinal disorders
Dyspepsia
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Gastrointestinal disorders
Nausea
6.7%
4/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
8.8%
3/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
General disorders
Fatigue
5.0%
3/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Hepatobiliary disorders
Liver disorder
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Bronchitis
6.7%
4/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
13.3%
2/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
COVID-19
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.1%
2/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Cystitis
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
5.9%
2/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Gastroenteritis
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Herpes zoster
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Nasopharyngitis
13.3%
8/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
8.3%
5/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
13.3%
2/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
12.1%
4/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Oral herpes
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Pharyngitis
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.1%
2/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Pneumonia
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Respiratory tract infection
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Upper respiratory tract infection
11.7%
7/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
8.3%
5/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
5.9%
2/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
9.1%
3/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Urinary tract infection
6.7%
4/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
4/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Infections and infestations
Vulvovaginal mycotic infection
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Investigations
Alanine aminotransferase increased
8.3%
5/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
11.7%
7/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
5.9%
2/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Investigations
Aspartate aminotransferase increased
5.0%
3/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
5.0%
3/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
5.9%
2/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Investigations
Blood creatine phosphokinase increased
6.7%
4/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
4/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.1%
2/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Investigations
Electrocardiogram QT prolonged
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
5.9%
2/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Investigations
Hepatic enzyme increased
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Investigations
Transaminases increased
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Investigations
Weight increased
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
5.9%
2/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.1%
2/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.1%
2/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Musculoskeletal and connective tissue disorders
Spinal pain
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Nervous system disorders
Headache
8.3%
5/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
4/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
12.5%
2/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
9.1%
3/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Nervous system disorders
Vertebrobasilar insufficiency
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Psychiatric disorders
Depression
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.7%
1/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Skin and subcutaneous tissue disorders
Acne
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Skin and subcutaneous tissue disorders
Psoriasis
1.7%
1/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.1%
2/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Skin and subcutaneous tissue disorders
Rash
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Skin and subcutaneous tissue disorders
Skin mass
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.1%
2/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Vascular disorders
Hypertension
8.3%
5/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.3%
2/60 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
6.2%
1/16 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
0.00%
0/15 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
2.9%
1/34 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
3.0%
1/33 • From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.

Additional Information

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Results disclosure agreements

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