Trial Outcomes & Findings for Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate (NCT NCT02996500)
NCT ID: NCT02996500
Last Updated: 2020-02-27
Results Overview
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. The primary analysis utilized a Bayesian ANCOVA model with an informative placebo prior distribution with borrowing from tofacitinib historical placebo data. The confidence interval was credible interval in this statistical analysis. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
269 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2020-02-27
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Tofa 10 mg
Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 200 mg
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
43
|
39
|
50
|
50
|
48
|
|
Overall Study
COMPLETED
|
31
|
42
|
29
|
46
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
10
|
4
|
5
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Tofa 10 mg
Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 200 mg
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
4
|
3
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Progressive Disease
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
2
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
3
|
0
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
Baseline characteristics by cohort
| Measure |
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Tofa 10 mg
n=43 Participants
Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.9 Years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
52.7 Years
STANDARD_DEVIATION 10.02 • n=7 Participants
|
55.9 Years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
51.0 Years
STANDARD_DEVIATION 12.05 • n=4 Participants
|
53.6 Years
STANDARD_DEVIATION 11.47 • n=21 Participants
|
54.8 Years
STANDARD_DEVIATION 8.76 • n=10 Participants
|
53.7 Years
STANDARD_DEVIATION 10.56 • n=115 Participants
|
|
Age, Customized
18-44 Years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Age, Customized
45-64 Years
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
179 Participants
n=115 Participants
|
|
Age, Customized
>=65 Years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
210 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
59 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
254 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. The primary analysis utilized a Bayesian ANCOVA model with an informative placebo prior distribution with borrowing from tofacitinib historical placebo data. The confidence interval was credible interval in this statistical analysis. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=44 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=45 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=34 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=30 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=45 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12
|
-24.77 units on a scale
Interval -28.54 to -21.08
|
-25.16 units on a scale
Interval -28.85 to -21.39
|
-13.87 units on a scale
Interval -17.7 to -10.02
|
-21.71 units on a scale
Interval -26.14 to -17.2
|
-22.83 units on a scale
Interval -26.57 to -19.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4 and 8Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. The descriptive summary of change from baseline in SDAI was based on a mixed effect model repeat measurement MMRM model with observed data. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SDAI at Weeks 4 and 8
Week 4
|
-13.56 units on a scale
Interval -17.25 to -9.86
|
-12.30 units on a scale
Interval -15.46 to -9.14
|
-10.78 units on a scale
Interval -15.07 to -6.49
|
-12.39 units on a scale
Interval -14.68 to -10.1
|
-14.29 units on a scale
Interval -16.87 to -11.71
|
—
|
|
Change From Baseline in SDAI at Weeks 4 and 8
Week 8
|
-19.95 units on a scale
Interval -24.81 to -15.08
|
-21.15 units on a scale
Interval -25.5 to -16.79
|
-17.07 units on a scale
Interval -22.58 to -11.55
|
-16.62 units on a scale
Interval -20.71 to -12.53
|
-18.85 units on a scale
Interval -22.03 to -15.67
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI LDAS was SDAI\<=11. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks
Week 4
|
10.6 percentage of participants
Interval 1.8 to 19.5
|
8.5 percentage of participants
Interval 0.5 to 16.5
|
8.1 percentage of participants
Interval 0.0 to 16.9
|
7.9 percentage of participants
Interval 0.0 to 16.5
|
12.2 percentage of participants
Interval 3.1 to 21.4
|
—
|
|
Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks
Week 8
|
29.3 percentage of participants
Interval 15.3 to 43.2
|
33.3 percentage of participants
Interval 19.6 to 47.1
|
14.7 percentage of participants
Interval 2.8 to 26.6
|
20.0 percentage of participants
Interval 6.7 to 33.3
|
17.4 percentage of participants
Interval 6.4 to 28.3
|
—
|
|
Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks
Week 12
|
38.6 percentage of participants
Interval 24.2 to 53.0
|
42.2 percentage of participants
Interval 27.8 to 56.7
|
26.5 percentage of participants
Interval 11.6 to 41.3
|
41.9 percentage of participants
Interval 24.6 to 59.3
|
28.9 percentage of participants
Interval 15.6 to 42.1
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI remission was SDAI\<=3.3. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks
Week 4
|
0 percentage of participants
Interval 0.0 to 0.0
|
2.1 percentage of participants
Interval 0.0 to 6.3
|
0 percentage of participants
Interval 0.0 to 0.0
|
2.6 percentage of participants
Interval 0.0 to 7.7
|
2.0 percentage of participants
Interval 0.0 to 6.0
|
—
|
|
Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks
Week 8
|
7.3 percentage of participants
Interval 0.0 to 15.3
|
2.2 percentage of participants
Interval 0.0 to 6.5
|
0 percentage of participants
Interval 0.0 to 0.0
|
8.6 percentage of participants
Interval 0.0 to 17.8
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks
Week 12
|
6.8 percentage of participants
Interval 0.0 to 14.3
|
8.9 percentage of participants
Interval 0.6 to 17.2
|
2.9 percentage of participants
Interval 0.0 to 8.6
|
3.2 percentage of participants
Interval 0.0 to 9.4
|
2.2 percentage of participants
Interval 0.0 to 6.5
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\] + 0.014 (PtGA \[mm\]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 (ESR) LDAS was DAS28\<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 4
|
8.3 percentage of participants
Interval 0.5 to 16.2
|
4.3 percentage of participants
Interval 0.0 to 10.0
|
2.9 percentage of participants
Interval 0.0 to 8.4
|
8.1 percentage of participants
Interval 0.0 to 16.9
|
6.4 percentage of participants
Interval 0.0 to 13.4
|
—
|
|
Percentage of Participants With Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 8
|
13.3 percentage of participants
Interval 3.4 to 23.3
|
12.8 percentage of participants
Interval 3.2 to 22.3
|
8.6 percentage of participants
Interval 0.0 to 17.8
|
17.1 percentage of participants
Interval 4.7 to 29.6
|
13.6 percentage of participants
Interval 3.5 to 23.8
|
—
|
|
Percentage of Participants With Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 12
|
22.2 percentage of participants
Interval 10.1 to 34.4
|
17.8 percentage of participants
Interval 6.6 to 28.9
|
17.6 percentage of participants
Interval 4.8 to 30.5
|
20.0 percentage of participants
Interval 5.7 to 34.3
|
24.4 percentage of participants
Interval 11.9 to 37.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\]\*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28\<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 12
|
22.2 percentage of participants
Interval 10.1 to 34.4
|
15.6 percentage of participants
Interval 5.0 to 26.1
|
20.6 percentage of participants
Interval 7.0 to 34.2
|
20.0 percentage of participants
Interval 5.7 to 34.3
|
22.2 percentage of participants
Interval 10.1 to 34.4
|
—
|
|
Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 4
|
8.3 percentage of participants
Interval 0.5 to 16.2
|
4.3 percentage of participants
Interval 0.0 to 10.0
|
5.7 percentage of participants
Interval 0.0 to 13.4
|
8.1 percentage of participants
Interval 0.0 to 16.9
|
10.6 percentage of participants
Interval 1.8 to 19.5
|
—
|
|
Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 8
|
8.9 percentage of participants
Interval 0.6 to 17.2
|
14.9 percentage of participants
Interval 4.7 to 25.1
|
8.6 percentage of participants
Interval 0.0 to 17.8
|
20.0 percentage of participants
Interval 6.7 to 33.3
|
15.9 percentage of participants
Interval 5.1 to 26.7
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PtGA \[mm\]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 LDAS was DAS28\<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 4
|
12.8 percentage of participants
Interval 3.2 to 22.3
|
8.5 percentage of participants
Interval 0.5 to 16.5
|
8.1 percentage of participants
Interval 0.0 to 16.9
|
13.2 percentage of participants
Interval 2.4 to 23.9
|
16.3 percentage of participants
Interval 6.0 to 26.7
|
—
|
|
Percentage of Participants With Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 8
|
26.8 percentage of participants
Interval 13.3 to 40.4
|
33.3 percentage of participants
Interval 19.6 to 47.1
|
11.8 percentage of participants
Interval 0.9 to 22.6
|
20.0 percentage of participants
Interval 6.7 to 33.3
|
19.6 percentage of participants
Interval 8.1 to 31.0
|
—
|
|
Percentage of Participants With Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 12
|
40.9 percentage of participants
Interval 26.4 to 55.4
|
42.2 percentage of participants
Interval 27.8 to 56.7
|
20.6 percentage of participants
Interval 7.0 to 34.2
|
38.7 percentage of participants
Interval 21.6 to 55.9
|
35.6 percentage of participants
Interval 21.6 to 49.5
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1)\*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28\<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 4
|
17.0 percentage of participants
Interval 6.3 to 27.8
|
10.6 percentage of participants
Interval 1.8 to 19.5
|
8.1 percentage of participants
Interval 0.0 to 16.9
|
10.5 percentage of participants
Interval 0.8 to 20.3
|
16.3 percentage of participants
Interval 6.0 to 26.7
|
—
|
|
Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 8
|
34.1 percentage of participants
Interval 19.6 to 48.7
|
37.8 percentage of participants
Interval 23.6 to 51.9
|
20.6 percentage of participants
Interval 7.0 to 34.2
|
22.9 percentage of participants
Interval 8.9 to 36.8
|
19.6 percentage of participants
Interval 8.1 to 31.0
|
—
|
|
Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Week 12
|
47.7 percentage of participants
Interval 33.0 to 62.5
|
42.2 percentage of participants
Interval 27.8 to 56.7
|
23.5 percentage of participants
Interval 9.3 to 37.8
|
41.9 percentage of participants
Interval 24.6 to 59.3
|
40.0 percentage of participants
Interval 25.7 to 54.3
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\] + 0.014 (PtGA \[mm\]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28\<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 4
|
8.3 percentage of participants
Interval 0.5 to 16.2
|
2.1 percentage of participants
Interval 0.0 to 6.3
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.4 percentage of participants
Interval 0.0 to 12.7
|
2.1 percentage of participants
Interval 0.0 to 6.3
|
—
|
|
Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 8
|
6.7 percentage of participants
Interval 0.0 to 14.0
|
10.6 percentage of participants
Interval 1.8 to 19.5
|
5.7 percentage of participants
Interval 0.0 to 13.4
|
11.4 percentage of participants
Interval 0.9 to 22.0
|
9.1 percentage of participants
Interval 0.6 to 17.6
|
—
|
|
Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 12
|
8.9 percentage of participants
Interval 0.6 to 17.2
|
11.1 percentage of participants
Interval 1.9 to 20.3
|
5.9 percentage of participants
Interval 0.0 to 13.8
|
16.7 percentage of participants
Interval 3.3 to 30.0
|
13.3 percentage of participants
Interval 3.4 to 23.3
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\]\*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28\<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 4
|
6.3 percentage of participants
Interval 0.0 to 13.1
|
2.1 percentage of participants
Interval 0.0 to 6.3
|
0 percentage of participants
Interval 0.0 to 0.0
|
2.7 percentage of participants
Interval 0.0 to 7.9
|
2.1 percentage of participants
Interval 0.0 to 6.3
|
—
|
|
Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 8
|
6.7 percentage of participants
Interval 0.0 to 14.0
|
8.5 percentage of participants
Interval 0.5 to 16.5
|
2.9 percentage of participants
Interval 0.0 to 8.4
|
8.6 percentage of participants
Interval 0.0 to 17.8
|
9.1 percentage of participants
Interval 0.6 to 17.6
|
—
|
|
Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 12
|
11.1 percentage of participants
Interval 1.9 to 20.3
|
8.9 percentage of participants
Interval 0.6 to 17.2
|
8.8 percentage of participants
Interval 0.0 to 18.4
|
10.0 percentage of participants
Interval 0.0 to 20.7
|
13.3 percentage of participants
Interval 3.4 to 23.3
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PtGA \[mm\]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28\<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With DAS28-4 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 4
|
10.6 percentage of participants
Interval 1.8 to 19.5
|
6.4 percentage of participants
Interval 0.0 to 13.4
|
2.7 percentage of participants
Interval 0.0 to 7.9
|
5.3 percentage of participants
Interval 0.0 to 12.4
|
8.2 percentage of participants
Interval 0.5 to 15.8
|
—
|
|
Percentage of Participants With DAS28-4 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 8
|
22.0 percentage of participants
Interval 9.3 to 34.6
|
13.3 percentage of participants
Interval 3.4 to 23.3
|
8.8 percentage of participants
Interval 0.0 to 18.4
|
17.1 percentage of participants
Interval 4.7 to 29.6
|
10.9 percentage of participants
Interval 1.9 to 19.9
|
—
|
|
Percentage of Participants With DAS28-4 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 12
|
25.0 percentage of participants
Interval 12.2 to 37.8
|
24.4 percentage of participants
Interval 11.9 to 37.0
|
14.7 percentage of participants
Interval 2.8 to 26.6
|
22.6 percentage of participants
Interval 7.9 to 37.3
|
17.8 percentage of participants
Interval 6.6 to 28.9
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1)\*1.10+1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28\<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With DAS28-3 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 4
|
8.5 percentage of participants
Interval 0.5 to 16.5
|
4.3 percentage of participants
Interval 0.0 to 10.0
|
5.4 percentage of participants
Interval 0.0 to 12.7
|
5.3 percentage of participants
Interval 0.0 to 12.4
|
10.2 percentage of participants
Interval 1.7 to 18.7
|
—
|
|
Percentage of Participants With DAS28-3 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 8
|
22.0 percentage of participants
Interval 9.3 to 34.6
|
13.3 percentage of participants
Interval 3.4 to 23.3
|
8.8 percentage of participants
Interval 0.0 to 18.4
|
14.3 percentage of participants
Interval 2.7 to 25.9
|
10.9 percentage of participants
Interval 1.9 to 19.9
|
—
|
|
Percentage of Participants With DAS28-3 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Week 12
|
22.7 percentage of participants
Interval 10.3 to 35.1
|
22.2 percentage of participants
Interval 10.1 to 34.4
|
11.8 percentage of participants
Interval 0.9 to 22.6
|
25.8 percentage of participants
Interval 10.4 to 41.2
|
22.2 percentage of participants
Interval 10.1 to 34.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed.It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\] + 0.014 (PtGA \[mm\]). Higher score indicated more disease activity. Total score range: 0-9.4. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-4 (ESR) at 4, 8 and 12 Weeks
Week 4
|
-1.14 units on a scale
Interval -1.42 to -0.86
|
-1.13 units on a scale
Interval -1.42 to -0.84
|
-0.80 units on a scale
Interval -1.13 to -0.47
|
-1.15 units on a scale
Interval -1.47 to -0.82
|
-1.35 units on a scale
Interval -1.64 to -1.07
|
—
|
|
Change From Baseline in DAS28-4 (ESR) at 4, 8 and 12 Weeks
Week 8
|
-1.77 units on a scale
Interval -2.14 to -1.41
|
-2.01 units on a scale
Interval -2.37 to -1.64
|
-1.38 units on a scale
Interval -1.8 to -0.97
|
-1.59 units on a scale
Interval -2.01 to -1.17
|
-1.92 units on a scale
Interval -2.29 to -1.56
|
—
|
|
Change From Baseline in DAS28-4 (ESR) at 4, 8 and 12 Weeks
Week 12
|
-2.23 units on a scale
Interval -2.6 to -1.86
|
-2.36 units on a scale
Interval -2.73 to -1.99
|
-1.55 units on a scale
Interval -1.97 to -1.13
|
-1.85 units on a scale
Interval -2.28 to -1.41
|
-2.37 units on a scale
Interval -2.74 to -2.01
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR) \[mm/first hour\]\*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-3 (ESR) at 4, 8 and 12 Weeks
Week 4
|
-1.08 units on a scale
Interval -1.35 to -0.8
|
-1.02 units on a scale
Interval -1.29 to -0.74
|
-0.69 units on a scale
Interval -1.01 to -0.38
|
-1.08 units on a scale
Interval -1.39 to -0.77
|
-1.25 units on a scale
Interval -1.52 to -0.97
|
—
|
|
Change From Baseline in DAS28-3 (ESR) at 4, 8 and 12 Weeks
Week 8
|
-1.62 units on a scale
Interval -1.97 to -1.27
|
-1.79 units on a scale
Interval -2.14 to -1.44
|
-1.14 units on a scale
Interval -1.54 to -0.75
|
-1.52 units on a scale
Interval -1.92 to -1.12
|
-1.80 units on a scale
Interval -2.15 to -1.45
|
—
|
|
Change From Baseline in DAS28-3 (ESR) at 4, 8 and 12 Weeks
Week 12
|
-2.05 units on a scale
Interval -2.4 to -1.71
|
-2.04 units on a scale
Interval -2.38 to -1.69
|
-1.31 units on a scale
Interval -1.71 to -0.92
|
-1.69 units on a scale
Interval -2.09 to -1.28
|
-2.26 units on a scale
Interval -2.6 to -1.91
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PtGA \[mm\]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-4 (CRP) at 4, 8 and 12 Weeks
Week 4
|
-1.08 units on a scale
Interval -1.34 to -0.81
|
-0.99 units on a scale
Interval -1.25 to -0.72
|
-0.72 units on a scale
Interval -1.02 to -0.42
|
-0.99 units on a scale
Interval -1.29 to -0.69
|
-1.21 units on a scale
Interval -1.47 to -0.94
|
—
|
|
Change From Baseline in DAS28-4 (CRP) at 4, 8 and 12 Weeks
Week 8
|
-1.65 units on a scale
Interval -1.98 to -1.32
|
-1.73 units on a scale
Interval -2.06 to -1.4
|
-1.20 units on a scale
Interval -1.58 to -0.83
|
-1.31 units on a scale
Interval -1.68 to -0.94
|
-1.59 units on a scale
Interval -1.92 to -1.27
|
—
|
|
Change From Baseline in DAS28-4 (CRP) at 4, 8 and 12 Weeks
Week 12
|
-2.00 units on a scale
Interval -2.36 to -1.65
|
-2.12 units on a scale
Interval -2.47 to -1.77
|
-1.38 units on a scale
Interval -1.78 to -0.97
|
-1.67 units on a scale
Interval -2.08 to -1.26
|
-1.94 units on a scale
Interval -2.29 to -1.59
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed.It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1)\*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-3 (CRP) at 4, 8 and 12 Weeks
Week 4
|
-1.01 units on a scale
Interval -1.27 to -0.76
|
-0.88 units on a scale
Interval -1.14 to -0.62
|
-0.61 units on a scale
Interval -0.9 to -0.32
|
-0.93 units on a scale
Interval -1.22 to -0.64
|
-1.09 units on a scale
Interval -1.35 to -0.84
|
—
|
|
Change From Baseline in DAS28-3 (CRP) at 4, 8 and 12 Weeks
Week 8
|
-1.52 units on a scale
Interval -1.83 to -1.2
|
-1.52 units on a scale
Interval -1.83 to -1.21
|
-0.97 units on a scale
Interval -1.32 to -0.61
|
-1.24 units on a scale
Interval -1.6 to -0.89
|
-1.46 units on a scale
Interval -1.76 to -1.15
|
—
|
|
Change From Baseline in DAS28-3 (CRP) at 4, 8 and 12 Weeks
Week 12
|
-1.83 units on a scale
Interval -2.15 to -1.5
|
-1.82 units on a scale
Interval -2.15 to -1.5
|
-1.14 units on a scale
Interval -1.52 to -0.77
|
-1.53 units on a scale
Interval -1.91 to -1.15
|
-1.82 units on a scale
Interval -2.14 to -1.5
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
ACR20 was calculated as a 20% improvement in TJC and SJC and 20% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 4, 8 and 12 Weeks
Week 4
|
40.0 percentage of participants
Interval 26.4 to 53.6
|
37.5 percentage of participants
Interval 23.8 to 51.2
|
30.8 percentage of participants
Interval 16.3 to 45.3
|
35.9 percentage of participants
Interval 20.8 to 51.0
|
42.0 percentage of participants
Interval 28.3 to 55.7
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 4, 8 and 12 Weeks
Week 8
|
52.0 percentage of participants
Interval 38.2 to 65.8
|
64.6 percentage of participants
Interval 51.1 to 78.1
|
46.2 percentage of participants
Interval 30.5 to 61.8
|
51.3 percentage of participants
Interval 35.6 to 67.0
|
58.0 percentage of participants
Interval 44.3 to 71.7
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 4, 8 and 12 Weeks
Week 12
|
62.0 percentage of participants
Interval 48.5 to 75.5
|
70.8 percentage of participants
Interval 58.0 to 83.7
|
51.3 percentage of participants
Interval 35.6 to 67.0
|
48.7 percentage of participants
Interval 33.0 to 64.4
|
66.0 percentage of participants
Interval 52.9 to 79.1
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
ACR50 was calculated as a 50% improvement in TJC and SJC and 50% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at 4, 8 and 12 Weeks
Week 4
|
6.0 percentage of participants
Interval 0.0 to 12.6
|
8.3 percentage of participants
Interval 0.5 to 16.2
|
2.6 percentage of participants
Interval 0.0 to 7.5
|
10.3 percentage of participants
Interval 0.7 to 19.8
|
6.0 percentage of participants
Interval 0.0 to 12.6
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at 4, 8 and 12 Weeks
Week 8
|
22.0 percentage of participants
Interval 10.5 to 33.5
|
35.4 percentage of participants
Interval 21.9 to 48.9
|
12.8 percentage of participants
Interval 2.3 to 23.3
|
23.1 percentage of participants
Interval 9.9 to 36.3
|
14.0 percentage of participants
Interval 4.4 to 23.6
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at 4, 8 and 12 Weeks
Week 12
|
40.0 percentage of participants
Interval 26.4 to 53.6
|
43.8 percentage of participants
Interval 29.7 to 57.8
|
20.5 percentage of participants
Interval 7.8 to 33.2
|
25.6 percentage of participants
Interval 11.9 to 39.3
|
22.0 percentage of participants
Interval 10.5 to 33.5
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
ACR70 was calculated as a 70% improvement in TJC and SJC and 70% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at 4, 8 and 12 Weeks
Week 4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
4.2 percentage of participants
Interval 0.0 to 9.8
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
5.1 percentage of participants
Interval 0.0 to 12.1
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at 4, 8 and 12 Weeks
Week 8
|
10.0 percentage of participants
Interval 1.7 to 18.3
|
6.3 percentage of participants
Interval 0.0 to 13.1
|
2.6 percentage of participants
Interval 0.0 to 7.5
|
10.3 percentage of participants
Interval 0.7 to 19.8
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at 4, 8 and 12 Weeks
Week 12
|
14.0 percentage of participants
Interval 4.4 to 23.6
|
10.4 percentage of participants
Interval 1.8 to 19.1
|
5.1 percentage of participants
Interval 0.0 to 12.1
|
7.7 percentage of participants
Interval 0.0 to 16.1
|
6.0 percentage of participants
Interval 0.0 to 12.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The TJC (28) included the following joints: shoulders, elbows, wrists, metatarsophalangeal (MCP) joints, PIP joints, and knees. This count was calculated from the TJC (68) assessed. The SJC (28) included the same joints as TJC (28), and was calculated from the SJC 66 assessed for swelling.Sixty eight (68) joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. The 68 joints assessed were: temporomandibular, sternoclavicular, acromioclavicular; shoulder, elbow, wrist, MCPs, thumb interphalangeal, proximal interphalangeals, and distal interphalangeals; hip, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined. Sixty-six (66) joints were assessed for swelling, the same as those listed for TJC, excluding the right and left hip joints. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
SJC (28) at Week 4
|
-5.0 joints
Standard Deviation 4.87
|
-3.8 joints
Standard Deviation 4.25
|
-4.4 joints
Standard Deviation 6.01
|
-4.8 joints
Standard Deviation 3.64
|
-4.4 joints
Standard Deviation 3.76
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
SJC (66) at Week 4
|
-8.6 joints
Standard Deviation 9.00
|
-6.2 joints
Standard Deviation 8.00
|
-6.2 joints
Standard Deviation 10.82
|
-6.5 joints
Standard Deviation 5.07
|
-6.3 joints
Standard Deviation 5.27
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
TJC (68) at Week 12
|
-18.1 joints
Standard Deviation 15.00
|
-14.8 joints
Standard Deviation 11.98
|
-11.5 joints
Standard Deviation 12.24
|
-13.5 joints
Standard Deviation 11.44
|
-15.5 joints
Standard Deviation 11.30
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
SJC (28) at Week 8
|
-7.0 joints
Standard Deviation 5.31
|
-6.8 joints
Standard Deviation 5.75
|
-6.1 joints
Standard Deviation 6.75
|
-6.0 joints
Standard Deviation 4.70
|
-6.1 joints
Standard Deviation 4.80
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
SJC (28) at Week 12
|
-8.1 joints
Standard Deviation 5.73
|
-8.2 joints
Standard Deviation 6.01
|
-6.3 joints
Standard Deviation 5.61
|
-6.8 joints
Standard Deviation 5.21
|
-6.6 joints
Standard Deviation 5.38
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
TJC (28) at Week 4
|
-4.8 joints
Standard Deviation 6.14
|
-4.4 joints
Standard Deviation 5.36
|
-4.0 joints
Standard Deviation 5.99
|
-4.9 joints
Standard Deviation 5.01
|
-5.5 joints
Standard Deviation 5.12
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
TJC (28) at Week 8
|
-7.5 joints
Standard Deviation 7.13
|
-7.8 joints
Standard Deviation 6.72
|
-5.9 joints
Standard Deviation 7.16
|
-6.9 joints
Standard Deviation 6.18
|
-7.0 joints
Standard Deviation 5.83
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
TJC (28) at Week 12
|
-9.9 joints
Standard Deviation 7.24
|
-9.6 joints
Standard Deviation 6.65
|
-7.5 joints
Standard Deviation 6.39
|
-8.6 joints
Standard Deviation 6.36
|
-9.5 joints
Standard Deviation 6.14
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
SJC (66) at Week 8
|
-11.0 joints
Standard Deviation 8.81
|
-10.0 joints
Standard Deviation 9.92
|
-9.0 joints
Standard Deviation 10.87
|
-8.2 joints
Standard Deviation 7.03
|
-8.5 joints
Standard Deviation 6.74
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
SJC (66) at Week 12
|
-12.5 joints
Standard Deviation 9.00
|
-11.6 joints
Standard Deviation 10.19
|
-9.4 joints
Standard Deviation 9.92
|
-9.6 joints
Standard Deviation 7.76
|
-8.8 joints
Standard Deviation 7.11
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
TJC (68) at Week 4
|
-9.1 joints
Standard Deviation 12.22
|
-7.8 joints
Standard Deviation 9.60
|
-4.9 joints
Standard Deviation 11.28
|
-8.7 joints
Standard Deviation 8.96
|
-9.1 joints
Standard Deviation 8.45
|
—
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
TJC (68) at Week 8
|
-14.0 joints
Standard Deviation 14.61
|
-12.2 joints
Standard Deviation 11.40
|
-10.0 joints
Standard Deviation 13.41
|
-10.9 joints
Standard Deviation 10.48
|
-11.3 joints
Standard Deviation 9.46
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at 4, 8 and 12 Weeks
Week 4
|
-0.66 mg/dL
Interval -1.0 to -0.32
|
-0.65 mg/dL
Interval -1.0 to -0.31
|
0.22 mg/dL
Interval -0.17 to 0.6
|
-0.15 mg/dL
Interval -0.53 to 0.23
|
-0.66 mg/dL
Interval -1.0 to -0.32
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at 4, 8 and 12 Weeks
Week 8
|
-0.62 mg/dL
Interval -1.04 to -0.2
|
-0.61 mg/dL
Interval -1.02 to -0.2
|
0.12 mg/dL
Interval -0.35 to 0.59
|
0.07 mg/dL
Interval -0.39 to 0.53
|
-0.91 mg/dL
Interval -1.31 to -0.5
|
—
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at 4, 8 and 12 Weeks
Week 12
|
-0.68 mg/dL
Interval -1.09 to -0.27
|
-0.64 mg/dL
Interval -1.04 to -0.23
|
-0.07 mg/dL
Interval -0.54 to 0.39
|
-0.23 mg/dL
Interval -0.71 to 0.25
|
-0.74 mg/dL
Interval -1.14 to -0.34
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed.It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and was independent of the participant's reported assessments of PtGA (patient's global assessment of arthritis). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme". Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Physician's Global Assessment of Arthritis (PhGA) at 4, 8, and 12 Weeks
Week 4
|
-18.34 units on a scale
Interval -23.34 to -13.33
|
-18.06 units on a scale
Interval -23.2 to -12.92
|
-14.30 units on a scale
Interval -20.06 to -8.54
|
-18.54 units on a scale
Interval -24.31 to -12.78
|
-22.51 units on a scale
Interval -27.53 to -17.49
|
—
|
|
Change From Baseline in the Physician's Global Assessment of Arthritis (PhGA) at 4, 8, and 12 Weeks
Week 8
|
-27.86 units on a scale
Interval -33.31 to -22.42
|
-29.97 units on a scale
Interval -35.42 to -24.52
|
-25.86 units on a scale
Interval -32.11 to -19.62
|
-26.80 units on a scale
Interval -33.12 to -20.48
|
-27.76 units on a scale
Interval -33.21 to -22.31
|
—
|
|
Change From Baseline in the Physician's Global Assessment of Arthritis (PhGA) at 4, 8, and 12 Weeks
Week 12
|
-34.27 units on a scale
Interval -39.86 to -28.68
|
-36.34 units on a scale
Interval -41.95 to -30.73
|
-28.16 units on a scale
Interval -34.59 to -21.74
|
-30.28 units on a scale
Interval -36.98 to -23.58
|
-33.05 units on a scale
Interval -38.61 to -27.49
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)Population: The safety analysis population included the participants who received at least 1 dose of the investigational drug.
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=50 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=43 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=39 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
TEAEs (all causality)
|
27 Participants
|
19 Participants
|
17 Participants
|
17 Participants
|
20 Participants
|
23 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
TEAEs (treatment-related)
|
8 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
SAEs (all causality)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
SAEs (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)Population: The safety analysis population included all participants who received at least 1 dose of investigational drug and were evaluable for laboratory abnormalities.
Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test \[for all female participants\]) and urine (urine pregnancy test \[for all female participants\]). Each parameter was evaluated against commonly used and widely accepted criteria. Clinical significance of laboratory parameters was determined at the investigator's discretion. The investigator judged the abnormality.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=49 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=38 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=43 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=39 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
|
36 Participants
|
41 Participants
|
30 Participants
|
32 Participants
|
30 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)Population: The safety analysis population included all participants who received at least 1 dose of investigational drug and had evaluable vital signs data.
Vital Signs tests included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse rate. Vital signs categorical summarization criteria were 1), systolic BP (SBP) \<90 millimeters of mercury (mm Hg) or change from baseline (Chg) \>=30mm Hg; diastolic BP (DBP) \<50mm Hg or change from baseline \>=20mm Hg; 2), pulse rate \<40bpm or \> 120bpm.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=49 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=38 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=43 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=39 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Increase: Sitting Diastolic BP Chg >= 20 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Sitting Diastolic BP < 50 mm Hg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Sitting Pulse Rate < 40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Sitting Pulse Rate > 120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Sitting Systolic BP < 90 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Increase: Sitting Systolic BP Chg>= 30 mm Hg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Decrease: Sitting Systolic BP Chg >= 30 mm Hg
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Decrease: Sitting Diastolic BP Chg >= 20 mm Hg
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)Population: The safety analysis population included all participants who received at least 1 dose of investigational drug and had evaluable ECG data.
ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), QT interval corrected for heart rate using Fridericia's formula (QTcF interval), and QTc calculated using Bazett's correction factor (QTcB interval).
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=49 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=38 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=43 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=39 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcB interval >=480 and <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcB interval >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcF interval >=450 and <480 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcF interval >=480 and <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcF interval >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
PR interval increase>=25/50%
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QRS duration increase>=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcB interval increase>=30 and increase <60 msec
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcB interval increase>=60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcF interval increase>=30 and increase <60 msec
|
0 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcF interval increase>=60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
PR interval >=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QRS duration >=140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QT interval >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
QTcB interval >=450 and <480 msec
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)Population: The safety analysis population included all participants who received at least 1 dose of investigational drug and had evaluable urinalysis data
The urine sample was collected for central laboratory urinalysis and urine microscopy. The urinalysis included pH, protein, glucose, erythrocytes, leukocytes, ketones, nitrite, urobilinogen, urine bilirubin, urine hemoglobin, leukocyte esterase, granular casts, hyaline casts, bacteria, atypical, needle-like crystals urine, specific gravity, microscopy and urine albumin test.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=49 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=38 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=43 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=39 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Specific gravity <1.003
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Specific gravity >1.030
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
pH <4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
pH >8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Urine glucose >=1
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Ketones >=1
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Urine protein >=1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Urine hemoglobin >=1
|
5 Participants
|
12 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Urobilinogen >=1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Urine bilirubin >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Nitrite >=1
|
1 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Leukocyte esterase >=1
|
14 Participants
|
19 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
19 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Urine erythrocytes(/HPF) >=20
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Urine leukocytes (/HPF) >=20
|
2 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Granular casts (/LPF) >1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Hyaline Casts (/LPF)
|
7 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Bacteria >20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Atypical, needle-like crystals urine >=1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
Patients assess the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. This assessment was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Patient's Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12
Week 4
|
-9.5 units on a scale
Standard Deviation 16.10
|
-11.3 units on a scale
Standard Deviation 21.22
|
-12.8 units on a scale
Standard Deviation 18.85
|
-11.5 units on a scale
Standard Deviation 19.44
|
-16.8 units on a scale
Standard Deviation 20.19
|
—
|
|
Change From Baseline in the Patient's Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12
Week 12
|
-25.7 units on a scale
Standard Deviation 24.02
|
-31.08 units on a scale
Standard Deviation 23.70
|
-25.9 units on a scale
Standard Deviation 26.39
|
-21.4 units on a scale
Standard Deviation 25.03
|
-23.0 units on a scale
Standard Deviation 21.46
|
—
|
|
Change From Baseline in the Patient's Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12
Week 8
|
-20.5 units on a scale
Standard Deviation 23.70
|
-23.5 units on a scale
Standard Deviation 20.42
|
-22.4 units on a scale
Standard Deviation 20.05
|
-15.4 units on a scale
Standard Deviation 21.32
|
-22.2 units on a scale
Standard Deviation 18.88
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
Patients answer the following question: "Considering all the ways your arthritis affects you, how are you feeling today?" The patient's response is recorded using a 100 mm VAS. This assessment was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. The higher score indicated more severe disease. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12
Week 4
|
-10.7 units on a scale
Standard Deviation 19.11
|
-13.7 units on a scale
Standard Deviation 20.29
|
-12.0 units on a scale
Standard Deviation 21.55
|
-10.0 units on a scale
Standard Deviation 16.68
|
-14.9 units on a scale
Standard Deviation 20.52
|
—
|
|
Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12
Week 8
|
-22.2 units on a scale
Standard Deviation 27.34
|
-25.3 units on a scale
Standard Deviation 20.74
|
-24.9 units on a scale
Standard Deviation 21.25
|
-13.1 units on a scale
Standard Deviation 23.47
|
-19.6 units on a scale
Standard Deviation 19.60
|
—
|
|
Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12
Week 12
|
-26.5 units on a scale
Standard Deviation 25.23
|
-34.2 units on a scale
Standard Deviation 22.81
|
-25.9 units on a scale
Standard Deviation 25.03
|
-20.0 units on a scale
Standard Deviation 23.12
|
-19.7 units on a scale
Standard Deviation 25.71
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: The analysis population included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (PF-06650833, tofacitinib, or placebo).
The HAQ-DI was defined as participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Weeks 4, 8, and 12
Week 4
|
-0.2 units on a scale
Standard Deviation 0.43
|
-0.3 units on a scale
Standard Deviation 0.49
|
-0.2 units on a scale
Standard Deviation 0.46
|
-0.2 units on a scale
Standard Deviation 0.44
|
-0.3 units on a scale
Standard Deviation 0.40
|
—
|
|
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Weeks 4, 8, and 12
Week 8
|
-0.4 units on a scale
Standard Deviation 0.56
|
-0.5 units on a scale
Standard Deviation 0.59
|
-0.4 units on a scale
Standard Deviation 0.47
|
-0.4 units on a scale
Standard Deviation 0.54
|
-0.4 units on a scale
Standard Deviation 0.41
|
—
|
|
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Weeks 4, 8, and 12
Week 12
|
-0.5 units on a scale
Standard Deviation 0.66
|
-0.6 units on a scale
Standard Deviation 0.59
|
-0.5 units on a scale
Standard Deviation 0.47
|
-0.5 units on a scale
Standard Deviation 0.60
|
-0.5 units on a scale
Standard Deviation 0.48
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The SF-36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The SF-36 summary scores range from 0-100, with higher scores representing better self-reported health. This was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Physical functioning domain
|
5.412 units on a scale
Standard Deviation 9.7871
|
7.322 units on a scale
Standard Deviation 11.2219
|
3.311 units on a scale
Standard Deviation 11.5441
|
4.885 units on a scale
Standard Deviation 8.4161
|
6.318 units on a scale
Standard Deviation 8.6700
|
—
|
|
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Role-physical domain
|
6.151 units on a scale
Standard Deviation 9.8448
|
6.734 units on a scale
Standard Deviation 9.3707
|
6.316 units on a scale
Standard Deviation 9.7393
|
5.773 units on a scale
Standard Deviation 10.0629
|
6.173 units on a scale
Standard Deviation 8.5158
|
—
|
|
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Bodily pain domain
|
7.071 units on a scale
Standard Deviation 9.6901
|
10.422 units on a scale
Standard Deviation 8.6959
|
7.840 units on a scale
Standard Deviation 7.2950
|
6.543 units on a scale
Standard Deviation 9.3835
|
7.280 units on a scale
Standard Deviation 8.1633
|
—
|
|
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
General health domain
|
4.916 units on a scale
Standard Deviation 8.4424
|
7.046 units on a scale
Standard Deviation 8.7992
|
5.775 units on a scale
Standard Deviation 6.7414
|
5.531 units on a scale
Standard Deviation 6.4448
|
4.856 units on a scale
Standard Deviation 6.5230
|
—
|
|
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Vitality domain
|
6.453 units on a scale
Standard Deviation 10.2902
|
8.182 units on a scale
Standard Deviation 8.7136
|
8.717 units on a scale
Standard Deviation 8.0179
|
7.049 units on a scale
Standard Deviation 9.9149
|
7.354 units on a scale
Standard Deviation 9.9326
|
—
|
|
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Social function domain
|
6.095 units on a scale
Standard Deviation 12.1659
|
8.485 units on a scale
Standard Deviation 9.2070
|
5.061 units on a scale
Standard Deviation 11.6125
|
6.418 units on a scale
Standard Deviation 11.6517
|
6.430 units on a scale
Standard Deviation 12.2952
|
—
|
|
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Role-emotional domain
|
6.730 units on a scale
Standard Deviation 12.7335
|
6.646 units on a scale
Standard Deviation 11.4190
|
7.683 units on a scale
Standard Deviation 11.2028
|
4.396 units on a scale
Standard Deviation 11.1492
|
5.103 units on a scale
Standard Deviation 12.5489
|
—
|
|
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Mental health domain
|
7.080 units on a scale
Standard Deviation 12.9887
|
8.866 units on a scale
Standard Deviation 10.4266
|
7.497 units on a scale
Standard Deviation 11.8826
|
5.161 units on a scale
Standard Deviation 11.7376
|
5.661 units on a scale
Standard Deviation 13.7839
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The SF 36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains. These domains can also be summarized as physical component score (PCS) and mental component score (MCS). The PCS and MCS summary scores range from 0-100, with higher scores representing better self-reported health. The lower the score the more disability. This was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Physical Component Score (PCS) and Mental Component Score (MCS) at Week 12
PCS
|
5.212 units on a scale
Standard Deviation 8.0162
|
7.476 units on a scale
Standard Deviation 8.3473
|
4.635 units on a scale
Standard Deviation 7.8031
|
5.728 units on a scale
Standard Deviation 7.4254
|
6.304 units on a scale
Standard Deviation 7.6091
|
—
|
|
Change From Baseline in the Physical Component Score (PCS) and Mental Component Score (MCS) at Week 12
MCS
|
6.749 units on a scale
Standard Deviation 12.0657
|
7.759 units on a scale
Standard Deviation 9.4263
|
7.995 units on a scale
Standard Deviation 11.5950
|
5.241 units on a scale
Standard Deviation 10.4860
|
5.425 units on a scale
Standard Deviation 13.6873
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The EQ-5D-3L health state profile is a patient completed questionnaire designed to assess impact on health related quality of life in 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Additionally, scores from the 5 domains might have been used to calculate a single index value, also known as a utility score. The validity and reliability of the EQ-5D-3L have been established in a number of disease states, including RA. EQ-5D-3L scores marked health status from 0 and 100. There were notes at the both ends of the scale that the bottom rate (0) corresponded to " the worst health you could imagine", and the highest rate (100) corresponded to "the best health you could imagine". Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=50 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=39 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the European Quality of Life 5 Dimensions-3 Level (EQ-5D-3L) Score at Week 12
EQ visual analogue scale (VAS) score
|
20.909 units on a scale
Standard Deviation 24.5895
|
20.778 units on a scale
Standard Deviation 20.6792
|
13.265 units on a scale
Standard Deviation 18.8540
|
11.129 units on a scale
Standard Deviation 24.6181
|
11.913 units on a scale
Standard Deviation 20.3795
|
—
|
|
Change From Baseline in the European Quality of Life 5 Dimensions-3 Level (EQ-5D-3L) Score at Week 12
Index value
|
0.143 units on a scale
Standard Deviation 0.2445
|
0.190 units on a scale
Standard Deviation 0.2201
|
0.132 units on a scale
Standard Deviation 0.2030
|
0.056 units on a scale
Standard Deviation 0.1957
|
0.118 units on a scale
Standard Deviation 0.1661
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The analysis population included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (PF-06650833, tofacitinib, or placebo). It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.
The FACIT-F is a patient completed questionnaire consisting of 13 items that assess fatigue. Instrument scoring yields a range from 0 to 52, with higher scores representing better patient status (less fatigue). This questionnaire was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Outcome measures
| Measure |
PF-06650833 200 mg
n=45 Participants
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=45 Participants
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Placebo
n=34 Participants
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=31 Participants
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=46 Participants
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
Participants received 4 modified release (MR) tablets of PF-06650833 400 mg once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Week 12
|
7.2 units on a scale
Standard Deviation 11.45
|
9.5 units on a scale
Standard Deviation 9.68
|
8.4 units on a scale
Standard Deviation 8.76
|
4.6 units on a scale
Standard Deviation 10.92
|
6.8 units on a scale
Standard Deviation 8.33
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Tofa 10 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-06650833 20 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
PF-06650833 60 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06650833 200 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-06650833 400 mg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=39 participants at risk
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Tofa 10 mg
n=43 participants at risk
Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 participants at risk
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 participants at risk
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 200 mg
n=50 participants at risk
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 participants at risk
Participants received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Epididymitis
|
2.6%
1/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.3%
1/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Placebo
n=39 participants at risk
Participants received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
|
Tofa 10 mg
n=43 participants at risk
Participants received 4 matching PF-06650833 MR placebo tablets QD and tofacitinib (Tofa) 10 mg (5 mg tablet BID) in 12 weeks treatment period.
|
PF-06650833 20 mg
n=39 participants at risk
Participants received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 60 mg
n=50 participants at risk
Participants received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablet QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 200 mg
n=50 participants at risk
Participants received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
PF-06650833 400 mg
n=48 participants at risk
Participants received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.3%
1/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.1%
2/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.7%
2/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.1%
2/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.0%
2/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
3/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.1%
2/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.7%
2/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
4/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.0%
2/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
3/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.1%
2/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.3%
1/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.0%
4/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.0%
2/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
2/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.0%
3/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
4/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.0%
2/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.2%
2/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Alanine aminotransferase increased
|
5.1%
2/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.3%
1/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.0%
2/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/43 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.0%
3/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.1%
1/48 • Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER