Trial Outcomes & Findings for TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE (NCT NCT04413617)
NCT ID: NCT04413617
Last Updated: 2023-04-07
Results Overview
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score\<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
460 participants
Primary outcome timeframe
BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12
Results posted on
2023-04-07
Participant Flow
Participant milestones
| Measure |
Tofacitinib 11mg MR
Participants received tofacitinib 11mg as modified release (MR) tablets once daily (QD).
|
PF-06651600 100mg
Participants received PF-06651600 100mg tablets QD.
|
PF-06650833 400mg MR
Participants received PF-06650833 400mg as MR tablets QD.
|
PF-06650833 400mg MR + Tofacitinib 11mg MR
Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.
|
PF-06650833 400mg MR + PF-06651600 100mg
Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
102
|
77
|
77
|
103
|
101
|
|
Overall Study
COMPLETED
|
95
|
71
|
73
|
95
|
96
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
4
|
8
|
5
|
Reasons for withdrawal
| Measure |
Tofacitinib 11mg MR
Participants received tofacitinib 11mg as modified release (MR) tablets once daily (QD).
|
PF-06651600 100mg
Participants received PF-06651600 100mg tablets QD.
|
PF-06650833 400mg MR
Participants received PF-06650833 400mg as MR tablets QD.
|
PF-06650833 400mg MR + Tofacitinib 11mg MR
Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.
|
PF-06650833 400mg MR + PF-06651600 100mg
Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.
|
|---|---|---|---|---|---|
|
Overall Study
Refused to come for FU visit and was contacted by phone
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
2
|
5
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
COVID-19
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
Baseline characteristics by cohort
| Measure |
Tofacitinib 11mg MR
n=102 Participants
Participants received tofacitinib 11mg MR tablets QD.
|
PF-06651600 100mg
n=77 Participants
Participants received PF-06651600 100mg tablets QD.
|
PF-06650833 400mg MR
n=77 Participants
Participants received PF-06650833 400mg as MR tablets QD.
|
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=103 Participants
Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.
|
PF-06650833 400mg MR + PF-06651600 100mg
n=101 Participants
Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.2 Years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
52.8 Years
STANDARD_DEVIATION 10.90 • n=7 Participants
|
53.6 Years
STANDARD_DEVIATION 9.87 • n=5 Participants
|
54.0 Years
STANDARD_DEVIATION 10.41 • n=4 Participants
|
53.0 Years
STANDARD_DEVIATION 10.40 • n=21 Participants
|
52.9 Years
STANDARD_DEVIATION 10.46 • n=8 Participants
|
|
Age, Customized
18-44
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
93 Participants
n=8 Participants
|
|
Age, Customized
45-64
|
68 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
310 Participants
n=8 Participants
|
|
Age, Customized
>=65
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
57 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
356 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
104 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
101 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
457 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12Population: The primary efficacy endpoint used Modified Intent to Treat (mITT) data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score\<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=96 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=93 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=96 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=69 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=71 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12
|
-2.65 Units on a scale
Interval -2.84 to -2.46
|
-2.35 Units on a scale
Interval -2.54 to -2.15
|
-2.30 Units on a scale
Interval -2.49 to -2.11
|
-2.20 Units on a scale
Interval -2.43 to -1.98
|
-1.82 Units on a scale
Interval -2.04 to -1.6
|
SECONDARY outcome
Timeframe: Week 24Population: The NRI data set included responders, non-responders, and non-responder assigned by NRI after removal of missingness due to COVID-19 and missing components at a given visit.
DAS28-CRP is derived using differential weighting given to 4 components: tender joint count, swollen joint count, patient global assessment, and CRP. Remission is defined as DAS28-CRP score \<2.6. Remission rate = the number of responders (who had remission) / (number of responders + non-responders + non-responder assigned by non-responder imputation \[NRI\] after removal of missingness due to COVID-19 and missing components at a given visit)
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=103 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=99 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=100 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=76 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=76 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
DAS28-CRP Remission (<2.6) Rates at Week 24
|
40.8 Percentage of participants
Interval 32.6 to 48.7
|
31.3 Percentage of participants
Interval 24.1 to 39.8
|
24.0 Percentage of participants
Interval 17.1 to 31.8
|
22.4 Percentage of participants
Interval 14.8 to 31.3
|
11.8 Percentage of participants
Interval 6.7 to 19.3
|
SECONDARY outcome
Timeframe: From first dose of study intervention (Day 1) to Week 28Population: The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=102 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=77 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=77 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=103 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=101 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
All-causality TEAEs
|
60 Participants
|
42 Participants
|
38 Participants
|
51 Participants
|
55 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
Treatment-related TEAEs
|
15 Participants
|
17 Participants
|
13 Participants
|
20 Participants
|
25 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
All-causality TESAEs
|
3 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
Treatment-related TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
Discontinuation from study due to all-causality TEAEs
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
Discontinuation from study due to treatment-related TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
Study drug withdrawal due to all-causality TEAEs but continued study
|
0 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
Study drug withdrawal due to treatment-related TEAEs but continued study
|
0 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From BL to Week 28Population: The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable laboratory values were analyzed.
Clinical laboratory abnormality was determined at the investigator's discretion.
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=101 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=77 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=77 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=102 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=101 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Urate (mg/dL) >1.2x ULN
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Activated Partial Thromboplastin Time (second [sec]) >1.1x ULN
|
9 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Prothrombin Time (sec) >1.1x ULN
|
7 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Hematology: Hemoglobin (gram per deciliter [g/dL]) <0.8x lower limit of normal (LLN)
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Erythrocytes (10^6/millimeter^3 [10^6/mm^3]) <0.8x LLN
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Erythrocyte (Ery.) Mean Corpuscular Volume (micrometer^3 [um^3]) <0.9x LLN
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular Volume (um^3) >1.1x upper limit of normal (ULN)
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular Hemoglobin (picogram/cell [pg/cell]) <0.9x LLN
|
8 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular Hemoglobin (HGB) Concentration (g/dL) <0.9x LLN
|
8 Participants
|
6 Participants
|
12 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Platelets (10^3/mm^3) >1.75xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Reticulocytes/Erythrocytes (%) >1.5x ULN
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Leukocytes (10^3/mm^3) <0.6x LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Leukocytes (10^3/mm^3) >1.5x ULN
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Lymphocytes (10^3/mm^3) <0.8x LLN
|
7 Participants
|
16 Participants
|
3 Participants
|
6 Participants
|
13 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Lymphocytes (10^3/mm^3) >1.2x ULN
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Lymphocytes/Leukocytes (%) <0.8x LLN
|
6 Participants
|
11 Participants
|
9 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Lymphocytes/Leukocytes (%) >1.2x ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Neutrophils (10^3/mm^3) <0.8x LLN
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Neutrophils (10^3/mm^3) >1.2x ULN
|
11 Participants
|
16 Participants
|
8 Participants
|
5 Participants
|
14 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Neutrophils/Leukocytes (%) <0.8x LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Neutrophils/Leukocytes (%) >1.2x ULN
|
5 Participants
|
9 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Basophils (10^3/mm^3) >1.2x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Eosinophils (10^3/mm^3) >1.2x ULN
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Eosinophils/Leukocytes (%) >1.2x ULN
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Monocytes (10^3/mm^3) >1.2x ULN
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Monocytes/Leukocytes (%) >1.2x ULN
|
8 Participants
|
12 Participants
|
6 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Erythrocyte Sedimentation Rate (millimeter per hour [mm/hr]) >1.5x ULN
|
72 Participants
|
59 Participants
|
58 Participants
|
71 Participants
|
63 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Clinical Chemistry: Bilirubin (milligram per deciliter [mg/dL]) >1.5x ULN
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Aspartate Aminotransferase (AST) (unit per liter [U/L]) >3.0x ULN
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Alanine Aminotransferase (ALT) (U/L) >3.0x ULN
|
0 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Urea Nitrogen (mg/dL) >1.3x ULN
|
4 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Creatinine (mg/dL) >1.3x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Cholesterol (mg/dL) >1.3x ULN
|
22 Participants
|
13 Participants
|
10 Participants
|
24 Participants
|
20 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
High-Density Lipoprotein (HDL) Cholesterol (mg/dL) <0.8x LLN
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Low-Density Lipoprotein (LDL) Cholesterol (mg/dL) >1.2x ULN
|
9 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Sodium (milliequivalent per liter [mEq/L]) <0.95x LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Potassium (mEq/L) <0.9x LLN
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Potassium (mEq/L) >1.1x ULN
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Chloride (mEq/L) <0.9x LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Calcium (mg/dL) <0.9x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Bicarbonate (mEq/L) <0.9x LLN
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Creatine Kinase (U/L) >2.0x ULN
|
4 Participants
|
7 Participants
|
1 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Troponin I (nanogram per milliliter [ng/mL]) >1.0x ULN
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Glucose -FASTING (mg/dL) >1.5x ULN
|
3 Participants
|
5 Participants
|
10 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Triglycerides -FASTING (mg/dL) >1.3x ULN
|
9 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Apolipoprotein A1 (mg/dL) >1.5x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Apolipoprotein B (mg/dL) >1.5x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From BL to Week 28Population: The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.
Abnormality in change from BL in vital signs included: sitting/semi-supine diastolic blood pressure (BP) increase and decrease from BL of \>=20mmHg, systolic BP increase and decrease from BL of \>=30mmHg
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=101 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=77 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=77 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=102 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=101 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Diastolic BP increase >=20mmHg
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Diastolic BP decrease >=20mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Systolic BP increase >=30mmHg
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Systolic BP decrease >=30mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study intervention (Day 1) to Week 28Population: The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
These AEs included severe and opportunistic infection AEs; herpes virus infection AEs; clinically significant categorical increases in hepatic enzymes AST, and ALT and total bilirubin, and potential cases meeting Hy's Law criteria for increased risk of drug induced liver injury (DILI); major adverse cardiovascular events, including pulmonary embolism and deep vein thrombosis, cerebrovascular accident; AEs for decreased renal function, acute kidney injury, clinically significant increases in serum creatinine (Scr) and decreases in estimated glomerular filtration rate (eGFR). Only participants with AEs mentioned above were reported in the table below.
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=102 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=77 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=77 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=103 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=101 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest
Herpes Zoster
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Oral Herpes
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Hyperbilirubinaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Transaminases Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest
ALT Increased
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest
AST Increased
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Hepatic Enzyme Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest
Liver Injury
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24Population: This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score\<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement.
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=84 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=73 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=80 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=54 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=49 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP at Week 24
|
-3.05 Units on a scale
Interval -3.26 to -2.85
|
-2.87 Units on a scale
Interval -3.08 to -2.65
|
-2.66 Units on a scale
Interval -2.88 to -2.45
|
-2.53 Units on a scale
Interval -2.78 to -2.28
|
-2.26 Units on a scale
Interval -2.51 to -2.0
|
SECONDARY outcome
Timeframe: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24Population: This endpoint used NRI data set included responders, non-responders, and non-responder assigned by NRI after removal of missingness due to COVID-19 and missing components at a given visit.
The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a \>=20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and CRP. Similarly, ACR50, ACR70, and ACR 90 were calculated with the respective percent improvement. Responder rate = number of responders (who had ACR20/50/70/90 response)/(number of responders + non-responders + non-responder assigned by non-responder imputation \[NRI\] after removal of missingness due to COVID-19 and missing components at a given visit)
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=103 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=101 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=101 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=77 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=76 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
ACR20 (Week 12)
|
86.41 Percentage of participants
Interval 79.94 to 91.59
|
79.21 Percentage of participants
Interval 71.99 to 85.62
|
83.17 Percentage of participants
Interval 75.94 to 88.98
|
72.73 Percentage of participants
Interval 63.8 to 80.94
|
75.00 Percentage of participants
Interval 66.26 to 82.24
|
|
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
ACR50 (Week 12)
|
62.75 Percentage of participants
Interval 54.69 to 70.75
|
54.46 Percentage of participants
Interval 45.79 to 62.57
|
46.53 Percentage of participants
Interval 38.04 to 55.19
|
44.16 Percentage of participants
Interval 34.59 to 54.16
|
38.16 Percentage of participants
Interval 29.16 to 47.81
|
|
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
ACR70 (Week 12)
|
21.36 Percentage of participants
Interval 15.35 to 28.95
|
25.74 Percentage of participants
Interval 19.17 to 33.29
|
23.76 Percentage of participants
Interval 16.96 to 31.42
|
18.18 Percentage of participants
Interval 11.34 to 26.08
|
10.53 Percentage of participants
Interval 5.39 to 18.17
|
|
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
ACR90 (Week 12)
|
2.91 Percentage of participants
Interval 1.07 to 6.86
|
3.96 Percentage of participants
Interval 1.74 to 8.58
|
0.99 Percentage of participants
Interval 0.1 to 4.12
|
1.30 Percentage of participants
Interval 0.14 to 5.32
|
1.32 Percentage of participants
Interval 0.14 to 5.39
|
|
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
ACR20 (Week 24)
|
75.73 Percentage of participants
Interval 68.31 to 82.41
|
70.00 Percentage of participants
Interval 61.87 to 77.31
|
75.25 Percentage of participants
Interval 67.64 to 82.11
|
67.53 Percentage of participants
Interval 57.99 to 76.32
|
55.26 Percentage of participants
Interval 45.2 to 65.01
|
|
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
ACR70 (Week 24)
|
45.63 Percentage of participants
Interval 37.25 to 54.2
|
44.00 Percentage of participants
Interval 35.61 to 52.72
|
44.55 Percentage of participants
Interval 36.6 to 53.22
|
31.17 Percentage of participants
Interval 22.51 to 40.74
|
27.63 Percentage of participants
Interval 19.32 to 36.52
|
|
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
ACR90 (Week 24)
|
12.62 Percentage of participants
Interval 8.05 to 19.19
|
18.00 Percentage of participants
Interval 12.27 to 25.23
|
9.90 Percentage of participants
Interval 5.58 to 16.09
|
5.19 Percentage of participants
Interval 2.28 to 11.34
|
1.32 Percentage of participants
Interval 0.14 to 5.39
|
|
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
ACR50 (Week 24)
|
65.05 Percentage of participants
Interval 57.08 to 72.34
|
65.00 Percentage of participants
Interval 56.68 to 72.92
|
65.35 Percentage of participants
Interval 57.14 to 73.21
|
54.55 Percentage of participants
Interval 44.56 to 63.8
|
43.42 Percentage of participants
Interval 33.74 to 53.5
|
SECONDARY outcome
Timeframe: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24Population: This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.
The endpoint included Tender/Painful Joint Count 68 (TJC68) and 28 (TJC28). TJC68 was assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful in upper body and upper/lower extremity. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). The 28-joints set is the subset of 68 joints set including the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. TJC28 was calculated by Pfizer from TJC68. Higher scores indicate higher level of disability.
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=100 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=93 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=96 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=69 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=72 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
TJC68 (Week 24)
|
-16.68 Joints
Interval -17.78 to -15.57
|
-17.68 Joints
Interval -18.82 to -16.53
|
-16.76 Joints
Interval -17.88 to -15.64
|
-16.69 Joints
Interval -18.02 to -15.36
|
-15.79 Joints
Interval -17.13 to -14.46
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
TJC28 (Week 12)
|
-9.87 Joints
Interval -10.65 to -9.09
|
-9.78 Joints
Interval -10.58 to -8.98
|
-9.84 Joints
Interval -10.63 to -9.05
|
-9.83 Joints
Interval -10.76 to -8.91
|
-8.82 Joints
Interval -9.73 to -7.92
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
TJC68 (Week 12)
|
-14.96 Joints
Interval -16.09 to -13.83
|
-15.66 Joints
Interval -16.81 to -14.5
|
-15.32 Joints
Interval -16.47 to -14.18
|
-14.80 Joints
Interval -16.13 to -13.46
|
-13.76 Joints
Interval -15.07 to -12.46
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
SJC28 (Week 12)
|
-8.61 Joints
Interval -9.16 to -8.06
|
-8.16 Joints
Interval -8.73 to -7.6
|
-7.86 Joints
Interval -8.41 to -7.3
|
-8.30 Joints
Interval -8.95 to -7.65
|
-7.80 Joints
Interval -8.44 to -7.15
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
SJC66 (Week 12)
|
-11.29 Joints
Interval -11.99 to -10.59
|
-10.90 Joints
Interval -11.62 to -10.19
|
-10.34 Joints
Interval -11.05 to -9.63
|
-10.75 Joints
Interval -11.58 to -9.92
|
-10.18 Joints
Interval -11.0 to -9.37
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
TJC28 (Week 24)
|
-11.33 Joints
Interval -12.06 to -10.61
|
-11.44 Joints
Interval -12.2 to -10.68
|
-10.60 Joints
Interval -11.34 to -9.86
|
-10.47 Joints
Interval -11.34 to -9.59
|
-10.31 Joints
Interval -11.2 to -9.42
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
SJC28 (Week 24)
|
-8.83 Joints
Interval -9.34 to -8.31
|
-9.44 Joints
Interval -9.98 to -8.9
|
-8.76 Joints
Interval -9.29 to -8.24
|
-8.71 Joints
Interval -9.33 to -8.08
|
-8.28 Joints
Interval -8.92 to -7.65
|
|
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
SJC66 (Week 24)
|
-11.41 Joints
Interval -12.02 to -10.8
|
-12.38 Joints
Interval -13.03 to -11.74
|
-11.59 Joints
Interval -12.21 to -10.97
|
-11.45 Joints
Interval -12.19 to -10.71
|
-11.10 Joints
Interval -11.86 to -10.34
|
SECONDARY outcome
Timeframe: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24Population: This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.
PhGA of Arthritis is an evaluation done by investigator based on the participant's disease signs, functional capacity and physical examination, and should be independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS. Physician's Global Assessment score ranges from 0 to 100. Higher scores indicate higher level of disability. A negative value in change from BL indicates an improvement.
Outcome measures
| Measure |
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=100 Participants
Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
|
PF-06650833 400mg MR + PF-06651600 100mg
n=93 Participants
Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
|
Tofacitinib 11mg MR
n=96 Participants
Participants who received tofacitinib 11mg MR
|
PF-06651600 100mg
n=69 Participants
Participants who received PF-06651600 100mg
|
PF-06650833 400mg MR
n=72 Participants
Participants who received PF-06650833 400mg MR
|
|---|---|---|---|---|---|
|
Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24
PhGA of Arthritis (Week 12)
|
-43.50 Units on a scale
Interval -46.32 to -40.69
|
-41.20 Units on a scale
Interval -44.06 to -38.34
|
-40.86 Units on a scale
Interval -43.72 to -38.0
|
-38.62 Units on a scale
Interval -41.95 to -35.28
|
-31.56 Units on a scale
Interval -34.82 to -28.3
|
|
Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24
PhGA of Arthritis (Week 24)
|
-47.50 Units on a scale
Interval -50.13 to -44.87
|
-48.21 Units on a scale
Interval -50.95 to -45.47
|
-47.31 Units on a scale
Interval -49.98 to -44.63
|
-43.42 Units on a scale
Interval -46.6 to -40.25
|
-39.27 Units on a scale
Interval -42.49 to -36.05
|
Adverse Events
Tofacitinib 11mg MR
Serious events: 3 serious events
Other events: 24 other events
Deaths: 1 deaths
PF-06651600 100mg
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
PF-06650833 400mg MR
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06650833 400mg MR + Tofacitinib 11mg MR
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
PF-06650833 400mg MR + PF-06651600 100mg
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tofacitinib 11mg MR
n=102 participants at risk
Participants received tofacitinib 11mg MR tablets QD.
|
PF-06651600 100mg
n=77 participants at risk
Participants received PF-06651600 100mg tablets QD.
|
PF-06650833 400mg MR
n=77 participants at risk
Participants received PF-06650833 400mg MR tablets QD.
|
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=103 participants at risk
Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.
|
PF-06650833 400mg MR + PF-06651600 100mg
n=101 participants at risk
Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.99%
1/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Infections and infestations
Coronavirus infection
|
0.98%
1/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma recurrent
|
0.98%
1/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.98%
1/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
Other adverse events
| Measure |
Tofacitinib 11mg MR
n=102 participants at risk
Participants received tofacitinib 11mg MR tablets QD.
|
PF-06651600 100mg
n=77 participants at risk
Participants received PF-06651600 100mg tablets QD.
|
PF-06650833 400mg MR
n=77 participants at risk
Participants received PF-06650833 400mg MR tablets QD.
|
PF-06650833 400mg MR + Tofacitinib 11mg MR
n=103 participants at risk
Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.
|
PF-06650833 400mg MR + PF-06651600 100mg
n=101 participants at risk
Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.9%
4/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
6.5%
5/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
2.6%
2/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.97%
1/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
3.0%
3/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
3/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
2.6%
2/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
2.9%
3/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
5.9%
6/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
5/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
6.8%
7/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
3.0%
3/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Investigations
SARS-CoV-2 test positive
|
6.9%
7/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
2.6%
2/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
3.9%
4/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
7.9%
8/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
3/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
6.5%
5/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.3%
1/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
1.9%
2/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
2.0%
2/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.9%
3/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
5.2%
4/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
5.2%
4/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.97%
1/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.99%
1/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Nervous system disorders
Headache
|
3.9%
4/102 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
5.2%
4/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
2.6%
2/77 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
2.9%
3/103 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
6.9%
7/101 • From first dose of study intervention (Day 1) to Week 28
SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/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