Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participants between the ages of 18 and 70 years. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA with a Total Score ≥6/10. * The participant has active disease at both Screening and Randomization, as defined by both: ≥6 joints tender or painful on motion, AND ≥6 joints swollen; and fulfills 1 of the following 2 criteria: High sensitivity C reactive protein (hsCRP) \>7 mg/L at Screening (Visit 1) as performed by the central laboratory OR Erythrocyte sedimentation rate (ESR) (Westergren method) \>28 mm h.
Exclusion criteria
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * Participants with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency. * Participants with any active or latent infections. * Participants with positive hepatitis B surface antigen (HBsAg). * Participants with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA). * Any history of either untreated or inadequately treated latent or active tuberculosis (TB) infection, current treatment for active or latent TB infection or evidence of currently active TB, * History of a major organ transplant (eg, heart, lung, kidney and liver) or hematopoietic stem cell/marrow transplant. * History of severe allergic or anaphylactoid reaction to kinase inhibitors, or corticosteroid preparations. * Known history of diverticulitis or symptomatic diverticulosis, perineal abscess or fistulae. * Participants with malignancy or history of malignancy (including lymphoma, leukemia, or lymphoproliferative disease). * Pre-existing chronic autoimmune disease (eg, inflammatory bowel disease, systemic lupus erythematosus, moderate-severe atopic dermatitis, dermatomyositis) other than RA. Secondary Sjogren's Syndrome (due to RA) may be included. * Participants with fibromyalgia will be excluded. * Previous treatment with total lymphoid irradiation. * Participants with an oral, tympanic, or temporal temperature of 38°C (100.4°F) or higher at baseline. * Participants may not receive any live/attenuated vaccine from 30 days prior to randomization during the course of the study, or for 30 days after the last dose of study medication. Participants who have current routine household contact with children who have received varicella or oral polio vaccine within 2 months of first study dose are also excluded. * History of any lymphoproliferative disorder. * Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease. * History of any prior deep vein thrombosis (DVT) or pulmonary embolism \[PE\]. * Recent (within 6 months of screening) myocardial infarction, coronary revascularization, or percutaneous angioplasty with or without placement of a coronary artery stent; acute coronary syndrome; chronic uncompensated heart failure or New York Heart Association Functional Class III or IV; left ventricular assist devices; implanted defibrillators. * Current severe chronic renal insufficiency or renal failure as defined by persistent (on repeated measurements) eGFR \<60 mL/min per 1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) calculation. * Any known coagulopathy or hypercoagulant syndrome. * Presence of any of the following laboratory abnormalities at screening or within the 3 months prior to first study dose: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥1.5 x the upper limit of normal (ULN); Participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤ ULN and other liver function assessments are normal; Absolute neutrophil count of \<1.5 x 109/L (\<1500/mm3). Participants with cyclic (benign ethnic) neutropenia will be excluded; Absolute lymphocyte count of \<0.5 x 109/L (\<500/mm3); Absolute white blood cell (WBC) count of \<3.0 x 109/L (\<3000/mm3); Hemoglobin \<9.0 g/dL (90 g/L); Platelet count ≤100 x 109/L (100,000 cells/mm3) or ≥1000 x 109/L (1,000,000 cells/mm3); Thrombocytopenia, as defined by a platelet count \<100 x 109/L (\<100,000/mm3) at screening visit or within the 3 months prior to first study dose. \[Screening laboratory tests with abnormal results may be repeated once to confirm abnormal results. If results return to normal protocol acceptable limits within the 4-week screening period, the participant may enter the study\]. \- Grade 3 or greater laboratory abnormality based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity scale, except for the following that are allowed: Grade 3 prothrombin time (PT) secondary to warfarin treatment; Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy. * Participants previously treated with a biologic DMARD (except for up to 25% of participants who may have been treated with 1, and only 1 prior TNF inhibitor) or any other recent DMARD treatment (eg, a JAK inhibitor), or participants currently treated with any other prohibited medications will be excluded. * Prior use of tofacitinib or other JAK inhibitor in the context of a clinical trial is excluded. Concomitant use of tofacitinib (other than as prescribed by the randomization scheme) or other JAK inhibitor is prohibited. * Participants who have previously been treated with other, non-TNFa inhibiting biologic DMARDs \[including, abatacept (Orencia®), tocilizumab (Actemra®), Sarilumab (Kevzara®), anakinra (Kineret®), rituximab (Rituxan®) or other selective B lymphocyte depleting agents, or other lymphocyte depleting agents/therapies (such as alemtuzab \[CamPath®\], natalizumab (Tysabri®), alkylating agents \[eg, cyclophosphamide or chlorambucil\], total lymphoid irradiation) are excluded from participation in the study. * Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of IP used in this study (whichever is longer). * Any 12-lead electrocardiogram (ECG) performed prior to randomization that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | From first dose of study intervention (Day 1) to Week 28 | 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. |
| Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | From BL to Week 28 | Clinical laboratory abnormality was determined at the investigator's discretion. |
| Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | From BL to Week 28 | 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 |
| Number of Participants With Adverse Events of Special Interest | From first dose of study intervention (Day 1) to Week 28 | 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. |
| DAS28-CRP Remission (<2.6) Rates at Week 24 | Week 24 | 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) |
| American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24 | 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) |
| Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24 | 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. |
| Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24 | 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. |
| Change From Baseline in DAS28-CRP at Week 24 | BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24 | 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. |
Countries
Bulgaria, Canada, Chile, Czechia, Georgia, Hungary, Poland, Slovakia, Spain, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib 11mg MR Participants received tofacitinib 11mg MR tablets QD. | 102 |
| PF-06651600 100mg Participants received PF-06651600 100mg tablets QD. | 77 |
| PF-06650833 400mg MR Participants received PF-06650833 400mg as MR tablets QD. | 77 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD. | 103 |
| PF-06650833 400mg MR + PF-06651600 100mg Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD. | 101 |
| Total | 460 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 1 | 1 |
| Overall Study | COVID-19 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 2 | 0 | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Refused to come for FU visit and was contacted by phone | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 2 | 5 | 3 |
Baseline characteristics
| Characteristic | Tofacitinib 11mg MR | PF-06651600 100mg | PF-06650833 400mg MR | PF-06650833 400mg MR + Tofacitinib 11mg MR | PF-06650833 400mg MR + PF-06651600 100mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 51.2 Years STANDARD_DEVIATION 10.63 | 52.8 Years STANDARD_DEVIATION 10.9 | 53.6 Years STANDARD_DEVIATION 9.87 | 54.0 Years STANDARD_DEVIATION 10.41 | 53.0 Years STANDARD_DEVIATION 10.4 | 52.9 Years STANDARD_DEVIATION 10.46 |
| Age, Customized 18-44 | 25 Participants | 17 Participants | 11 Participants | 19 Participants | 21 Participants | 93 Participants |
| Age, Customized 45-64 | 68 Participants | 49 Participants | 56 Participants | 71 Participants | 66 Participants | 310 Participants |
| Age, Customized >=65 | 9 Participants | 11 Participants | 10 Participants | 13 Participants | 14 Participants | 57 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 101 Participants | 76 Participants | 77 Participants | 102 Participants | 101 Participants | 457 Participants |
| Sex: Female, Male Female | 82 Participants | 62 Participants | 61 Participants | 78 Participants | 73 Participants | 356 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 16 Participants | 25 Participants | 28 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 102 | 0 / 77 | 0 / 77 | 0 / 103 | 0 / 101 |
| other Total, other adverse events | 24 / 102 | 18 / 77 | 11 / 77 | 19 / 103 | 26 / 101 |
| serious Total, serious adverse events | 3 / 102 | 3 / 77 | 3 / 77 | 0 / 103 | 1 / 101 |
Outcome results
Primary
Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12
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.
Time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | -2.65 Units on a scale |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | -2.35 Units on a scale |
| Tofacitinib 11mg MR | Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | -2.30 Units on a scale |
| PF-06651600 100mg | Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | -2.20 Units on a scale |
| PF-06650833 400mg MR | Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 | -1.82 Units on a scale |
Comparison: The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.p-value: 0.015890% CI: [-0.62, -0.08]Mixed Model Repeated Measures
Comparison: The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.p-value: 0.393390% CI: [-0.32, 0.23]Mixed Model Repeated Measures
Secondary
American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
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)
Time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR90 (Week 12) | 3.96 Percentage of participants |
| PF-06650833 400mg MR + PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR50 (Week 24) | 65.00 Percentage of participants |
| PF-06650833 400mg MR + PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR20 (Week 12) | 79.21 Percentage of participants |
| PF-06650833 400mg MR + PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR20 (Week 24) | 70.00 Percentage of participants |
| PF-06650833 400mg MR + PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR50 (Week 12) | 54.46 Percentage of participants |
| PF-06650833 400mg MR + PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR90 (Week 24) | 18.00 Percentage of participants |
| PF-06650833 400mg MR + PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR70 (Week 12) | 25.74 Percentage of participants |
| PF-06650833 400mg MR + PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR70 (Week 24) | 44.00 Percentage of participants |
| Tofacitinib 11mg MR | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR90 (Week 24) | 9.90 Percentage of participants |
| Tofacitinib 11mg MR | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR70 (Week 12) | 23.76 Percentage of participants |
| Tofacitinib 11mg MR | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR20 (Week 24) | 75.25 Percentage of participants |
| Tofacitinib 11mg MR | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR50 (Week 24) | 65.35 Percentage of participants |
| Tofacitinib 11mg MR | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR70 (Week 24) | 44.55 Percentage of participants |
| Tofacitinib 11mg 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) | 83.17 Percentage of participants |
| Tofacitinib 11mg MR | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR50 (Week 12) | 46.53 Percentage of participants |
| Tofacitinib 11mg MR | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR90 (Week 12) | 0.99 Percentage of participants |
| PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR90 (Week 12) | 1.30 Percentage of participants |
| PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR50 (Week 12) | 44.16 Percentage of participants |
| PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR70 (Week 12) | 18.18 Percentage of participants |
| PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR90 (Week 24) | 5.19 Percentage of participants |
| PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR70 (Week 24) | 31.17 Percentage of participants |
| PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR20 (Week 24) | 67.53 Percentage of participants |
| PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR50 (Week 24) | 54.55 Percentage of participants |
| PF-06651600 100mg | American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24 | ACR20 (Week 12) | 72.73 Percentage of participants |
| 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 | ACR70 (Week 12) | 10.53 Percentage of participants |
| 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 24) | 55.26 Percentage of participants |
| 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 | ACR50 (Week 12) | 38.16 Percentage of participants |
| 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 | ACR90 (Week 24) | 1.32 Percentage of participants |
| 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 | ACR90 (Week 12) | 1.32 Percentage of participants |
| 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) | 75.00 Percentage of participants |
| 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 | ACR70 (Week 24) | 27.63 Percentage of participants |
| 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 | ACR50 (Week 24) | 43.42 Percentage of participants |
Secondary
Change From Baseline in DAS28-CRP at Week 24
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.
Time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in DAS28-CRP at Week 24 | -3.05 Units on a scale |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in DAS28-CRP at Week 24 | -2.87 Units on a scale |
| Tofacitinib 11mg MR | Change From Baseline in DAS28-CRP at Week 24 | -2.66 Units on a scale |
| PF-06651600 100mg | Change From Baseline in DAS28-CRP at Week 24 | -2.53 Units on a scale |
| PF-06650833 400mg MR | Change From Baseline in DAS28-CRP at Week 24 | -2.26 Units on a scale |
Secondary
Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24
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.
Time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | PhGA of Arthritis (Week 12) | -41.20 Units on a scale |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | PhGA of Arthritis (Week 24) | -48.21 Units on a scale |
| Tofacitinib 11mg MR | Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | PhGA of Arthritis (Week 12) | -40.86 Units on a scale |
| Tofacitinib 11mg MR | Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | PhGA of Arthritis (Week 24) | -47.31 Units on a scale |
| PF-06651600 100mg | Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | PhGA of Arthritis (Week 24) | -43.42 Units on a scale |
| PF-06651600 100mg | Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24 | PhGA of Arthritis (Week 12) | -38.62 Units on a scale |
| 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) | -31.56 Units on a scale |
| 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 24) | -39.27 Units on a scale |
Secondary
Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
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.
Time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 12) | -9.87 Joints |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 12) | -14.96 Joints |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 12) | -11.29 Joints |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 24) | -11.33 Joints |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 24) | -11.41 Joints |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 12) | -8.61 Joints |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 24) | -16.68 Joints |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 24) | -8.83 Joints |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 24) | -12.38 Joints |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 12) | -10.90 Joints |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 12) | -8.16 Joints |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 24) | -9.44 Joints |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 12) | -9.78 Joints |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 12) | -15.66 Joints |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 24) | -17.68 Joints |
| PF-06650833 400mg MR + PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 24) | -11.44 Joints |
| Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 12) | -7.86 Joints |
| Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 24) | -8.76 Joints |
| Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 24) | -16.76 Joints |
| Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 24) | -11.59 Joints |
| Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 12) | -10.34 Joints |
| Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 24) | -10.60 Joints |
| Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 12) | -9.84 Joints |
| Tofacitinib 11mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 12) | -15.32 Joints |
| PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 12) | -8.30 Joints |
| PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 24) | -10.47 Joints |
| PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 12) | -14.80 Joints |
| PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 12) | -10.75 Joints |
| PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 24) | -8.71 Joints |
| PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 24) | -11.45 Joints |
| PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 24) | -16.69 Joints |
| PF-06651600 100mg | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 12) | -9.83 Joints |
| PF-06650833 400mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 24) | -11.10 Joints |
| PF-06650833 400mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC66 (Week 12) | -10.18 Joints |
| PF-06650833 400mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 24) | -8.28 Joints |
| PF-06650833 400mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 24) | -10.31 Joints |
| PF-06650833 400mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 24) | -15.79 Joints |
| PF-06650833 400mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC68 (Week 12) | -13.76 Joints |
| PF-06650833 400mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | TJC28 (Week 12) | -8.82 Joints |
| PF-06650833 400mg MR | Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24 | SJC28 (Week 12) | -7.80 Joints |
Secondary
DAS28-CRP Remission (<2.6) Rates at Week 24
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)
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | DAS28-CRP Remission (<2.6) Rates at Week 24 | 40.8 Percentage of participants |
| PF-06650833 400mg MR + PF-06651600 100mg | DAS28-CRP Remission (<2.6) Rates at Week 24 | 31.3 Percentage of participants |
| Tofacitinib 11mg MR | DAS28-CRP Remission (<2.6) Rates at Week 24 | 24.0 Percentage of participants |
| PF-06651600 100mg | DAS28-CRP Remission (<2.6) Rates at Week 24 | 22.4 Percentage of participants |
| PF-06650833 400mg MR | DAS28-CRP Remission (<2.6) Rates at Week 24 | 11.8 Percentage of participants |
Secondary
Number of Participants With Adverse Events of Special Interest
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.
Time frame: From first dose of study intervention (Day 1) to Week 28
Population: The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Hyperbilirubinaemia | 1 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | AST Increased | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Liver Injury | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Hepatic Enzyme Increased | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Herpes Zoster | 1 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Transaminases Increased | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Oral Herpes | 1 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | ALT Increased | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Hyperbilirubinaemia | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | ALT Increased | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Liver Injury | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | AST Increased | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Oral Herpes | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Transaminases Increased | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Hepatic Enzyme Increased | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Herpes Zoster | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Liver Injury | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | AST Increased | 2 Participants |
| Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Herpes Zoster | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Oral Herpes | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | ALT Increased | 3 Participants |
| Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Hyperbilirubinaemia | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Transaminases Increased | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Adverse Events of Special Interest | Hepatic Enzyme Increased | 1 Participants |
| PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | AST Increased | 2 Participants |
| PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Oral Herpes | 1 Participants |
| PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Liver Injury | 0 Participants |
| PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Herpes Zoster | 2 Participants |
| PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Hyperbilirubinaemia | 0 Participants |
| PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Transaminases Increased | 0 Participants |
| PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | Hepatic Enzyme Increased | 0 Participants |
| PF-06651600 100mg | Number of Participants With Adverse Events of Special Interest | ALT Increased | 2 Participants |
| PF-06650833 400mg MR | Number of Participants With Adverse Events of Special Interest | ALT Increased | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Adverse Events of Special Interest | Oral Herpes | 2 Participants |
| PF-06650833 400mg MR | Number of Participants With Adverse Events of Special Interest | Transaminases Increased | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Adverse Events of Special Interest | Liver Injury | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Adverse Events of Special Interest | Hyperbilirubinaemia | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Adverse Events of Special Interest | Herpes Zoster | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Adverse Events of Special Interest | AST Increased | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Adverse Events of Special Interest | Hepatic Enzyme Increased | 0 Participants |
Secondary
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
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
Time frame: From BL to Week 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP decrease >=30mmHg | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Diastolic BP decrease >=20mmHg | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP increase >=30mmHg | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP increase >=30mmHg | 3 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Diastolic BP increase >=20mmHg | 2 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP decrease >=30mmHg | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Diastolic BP decrease >=20mmHg | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Diastolic BP decrease >=20mmHg | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP decrease >=30mmHg | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Diastolic BP increase >=20mmHg | 3 Participants |
| Tofacitinib 11mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP increase >=30mmHg | 4 Participants |
| PF-06651600 100mg | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Diastolic BP decrease >=20mmHg | 0 Participants |
| PF-06651600 100mg | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP increase >=30mmHg | 2 Participants |
| PF-06651600 100mg | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Diastolic BP increase >=20mmHg | 6 Participants |
| PF-06651600 100mg | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP decrease >=30mmHg | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP decrease >=30mmHg | 0 Participants |
| 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 | 3 Participants |
| PF-06650833 400mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Systolic BP increase >=30mmHg | 3 Participants |
| PF-06650833 400mg MR | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Diastolic BP decrease >=20mmHg | 0 Participants |
Secondary
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
Clinical laboratory abnormality was determined at the investigator's discretion.
Time frame: From BL to Week 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein B (mg/dL) >1.5x ULN | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) >1.2x ULN | 1 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) >1.2x ULN | 5 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1x ULN | 2 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) <0.8x LLN | 1 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) <0.8x LLN | 6 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9x LLN | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Eosinophils/Leukocytes (%) >1.2x ULN | 1 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Glucose -FASTING (mg/dL) >1.5x ULN | 3 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Cholesterol (mg/dL) >1.3x ULN | 22 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9x LLN | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urate (mg/dL) >1.2x ULN | 3 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatine Kinase (U/L) >2.0x ULN | 4 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75xULN | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Triglycerides -FASTING (mg/dL) >1.3x ULN | 9 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3x ULN | 4 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein A1 (mg/dL) >1.5x ULN | 0 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9x LLN | 4 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) >1.5x ULN | 2 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Prothrombin Time (sec) >1.1x ULN | 7 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 8 Participants |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Monocytes (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9x LLN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) <0.8x LLN | 16 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 2 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urate (mg/dL) >1.2x ULN | 2 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) >1.2x ULN | 2 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) <0.8x LLN | 11 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 6 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatine Kinase (U/L) >2.0x ULN | 7 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) >1.2x ULN | 9 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) <0.6x LLN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) >1.2x ULN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1x ULN | 3 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Glucose -FASTING (mg/dL) >1.5x ULN | 5 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) <0.8x LLN | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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) | 3 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) >1.2x ULN | 16 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) >1.5x ULN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Triglycerides -FASTING (mg/dL) >1.3x ULN | 7 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75xULN | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9x LLN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Prothrombin Time (sec) >1.1x ULN | 6 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Sodium (milliequivalent per liter [mEq/L]) <0.95x LLN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Alanine Aminotransferase (ALT) (U/L) >3.0x ULN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Eosinophils/Leukocytes (%) >1.2x ULN | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 2 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 59 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein A1 (mg/dL) >1.5x ULN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 5 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein B (mg/dL) >1.5x ULN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 12 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3x ULN | 1 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 3 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 3 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9x LLN | 2 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Cholesterol (mg/dL) >1.3x ULN | 13 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 5 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) >1.5x ULN | 2 Participants |
| Tofacitinib 11mg MR | 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) | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75xULN | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) >1.5x ULN | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) >1.2x ULN | 6 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Eosinophils/Leukocytes (%) >1.2x ULN | 5 Participants |
| Tofacitinib 11mg MR | 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 | 58 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3x ULN | 5 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9x LLN | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatine Kinase (U/L) >2.0x ULN | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Glucose -FASTING (mg/dL) >1.5x ULN | 10 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Triglycerides -FASTING (mg/dL) >1.3x ULN | 4 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein B (mg/dL) >1.5x ULN | 0 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | 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 | 0 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | 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 | 3 Participants |
| Tofacitinib 11mg MR | 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 | 12 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) <0.8x LLN | 3 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) >1.2x ULN | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) <0.8x LLN | 9 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) >1.2x ULN | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) <0.8x LLN | 3 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) >1.2x ULN | 8 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) <0.8x LLN | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Basophils (10^3/mm^3) >1.2x ULN | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Eosinophils (10^3/mm^3) >1.2x ULN | 3 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Monocytes (10^3/mm^3) >1.2x ULN | 1 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 6 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Prothrombin Time (sec) >1.1x ULN | 6 Participants |
| Tofacitinib 11mg MR | 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 | 0 Participants |
| Tofacitinib 11mg MR | 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 | 2 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Alanine Aminotransferase (ALT) (U/L) >3.0x ULN | 7 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urate (mg/dL) >1.2x ULN | 2 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Cholesterol (mg/dL) >1.3x ULN | 10 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | 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 | 1 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9x LLN | 2 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1x ULN | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9x LLN | 0 Participants |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein A1 (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06651600 100mg | 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 |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 11 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) >1.5x ULN | 1 Participants |
| PF-06651600 100mg | 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 | 10 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Activated Partial Thromboplastin Time (second [sec]) >1.1x ULN | 10 Participants |
| PF-06651600 100mg | 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) | 3 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75xULN | 1 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Prothrombin Time (sec) >1.1x ULN | 2 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatine Kinase (U/L) >2.0x ULN | 10 Participants |
| PF-06651600 100mg | 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 | 0 Participants |
| PF-06651600 100mg | 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 | 2 Participants |
| PF-06651600 100mg | 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 | 1 Participants |
| PF-06651600 100mg | 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 |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Alanine Aminotransferase (ALT) (U/L) >3.0x ULN | 2 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Triglycerides -FASTING (mg/dL) >1.3x ULN | 7 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Glucose -FASTING (mg/dL) >1.5x ULN | 10 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3x ULN | 1 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9x LLN | 3 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein B (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urate (mg/dL) >1.2x ULN | 4 Participants |
| PF-06651600 100mg | 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 | 4 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Cholesterol (mg/dL) >1.3x ULN | 24 Participants |
| PF-06651600 100mg | 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 | 5 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3x ULN | 4 Participants |
| PF-06651600 100mg | 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 | 0 Participants |
| PF-06651600 100mg | 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 | 71 Participants |
| PF-06651600 100mg | 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 | 7 Participants |
| PF-06651600 100mg | 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 |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) >1.2x ULN | 3 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein A1 (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9x LLN | 0 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1x ULN | 1 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9x LLN | 0 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) >1.2x ULN | 5 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) <0.8x LLN | 5 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) >1.5x ULN | 1 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) <0.8x LLN | 2 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) >1.2x ULN | 5 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) <0.8x LLN | 6 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Basophils (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06651600 100mg | 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 |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Eosinophils (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Eosinophils/Leukocytes (%) >1.2x ULN | 4 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) <0.8x LLN | 6 Participants |
| PF-06651600 100mg | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Monocytes (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Cholesterol (mg/dL) >1.3x ULN | 20 Participants |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) <0.6x LLN | 1 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) <0.8x LLN | 10 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Calcium (mg/dL) <0.9x LLN | 1 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) <0.8x LLN | 4 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 17 Participants |
| PF-06650833 400mg MR | 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 | 4 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Chloride (mEq/L) <0.9x LLN | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Platelets (10^3/mm^3) >1.75xULN | 0 Participants |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Activated Partial Thromboplastin Time (second [sec]) >1.1x ULN | 10 Participants |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | 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 | 63 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Eosinophils/Leukocytes (%) >1.2x ULN | 1 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils (10^3/mm^3) >1.2x ULN | 14 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Prothrombin Time (sec) >1.1x ULN | 9 Participants |
| PF-06650833 400mg MR | 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 | 0 Participants |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein B (mg/dL) >1.5x ULN | 0 Participants |
| PF-06650833 400mg MR | 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 | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) <0.8x LLN | 13 Participants |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatine Kinase (U/L) >2.0x ULN | 9 Participants |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) >1.2x ULN | 7 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Triglycerides -FASTING (mg/dL) >1.3x ULN | 5 Participants |
| PF-06650833 400mg MR | 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 | 4 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes/Leukocytes (%) >1.2x ULN | 3 Participants |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Reticulocytes/Erythrocytes (%) >1.5x ULN | 1 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Urea Nitrogen (mg/dL) >1.3x ULN | 2 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Glucose -FASTING (mg/dL) >1.5x ULN | 2 Participants |
| PF-06650833 400mg MR | 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 |
| PF-06650833 400mg MR | 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 | 4 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) <0.9x LLN | 1 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Bicarbonate (mEq/L) <0.9x LLN | 2 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Lymphocytes (10^3/mm^3) >1.2x ULN | 2 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Neutrophils/Leukocytes (%) <0.8x LLN | 1 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Apolipoprotein A1 (mg/dL) >1.5x ULN | 0 Participants |
| 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 | 1 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Potassium (mEq/L) >1.1x ULN | 1 Participants |
| PF-06650833 400mg MR | 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 | 8 Participants |
| PF-06650833 400mg MR | Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality) | Leukocytes (10^3/mm^3) >1.5x ULN | 3 Participants |
| PF-06650833 400mg MR | 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 |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
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.
Time frame: From first dose of study intervention (Day 1) to Week 28
Population: The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + Tofacitinib 11mg MR | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | All-causality TEAEs | 42 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | Treatment-related TEAEs | 17 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 6 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 4 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 | 0 Participants |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| PF-06650833 400mg MR + PF-06651600 100mg | 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 |
| Tofacitinib 11mg MR | 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 | 6 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | 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 | 0 Participants |
| Tofacitinib 11mg MR | 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 | 0 Participants |
| Tofacitinib 11mg 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 | 38 Participants |
| Tofacitinib 11mg MR | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | Treatment-related TEAEs | 13 Participants |
| Tofacitinib 11mg MR | 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 |
| Tofacitinib 11mg MR | 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 | 4 Participants |
| PF-06651600 100mg | 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 | 3 Participants |
| PF-06651600 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | All-causality TEAEs | 51 Participants |
| PF-06651600 100mg | 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 |
| PF-06651600 100mg | 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 | 4 Participants |
| PF-06651600 100mg | 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 |
| PF-06651600 100mg | 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 | 1 Participants |
| PF-06651600 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | All-causality TESAEs | 0 Participants |
| PF-06651600 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs | Treatment-related TEAEs | 20 Participants |
| 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 | Study drug withdrawal due to all-causality TEAEs but continued study | 6 Participants |
| 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 | Study drug withdrawal due to treatment-related TEAEs but continued study | 4 Participants |
| 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 | Treatment-related TEAEs | 25 Participants |
| 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 TESAEs | 1 Participants |
| 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 | Discontinuation from study due to all-causality TEAEs | 1 Participants |
| 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 | Discontinuation from study due to treatment-related TEAEs | 0 Participants |
| 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 | Treatment-related TESAEs | 0 Participants |
| 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 | 55 Participants |