TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-0665... | NCT04413617

ID	Type	Description	Link
2019-002676-14	EudraCT Number

Label	Type	Intervention Names
PF-06650833 + tofacitinib	Experimental	Drug: PF-06650833 Drug: Tofacitinib
PF-06650833 + PF-06651600	Experimental	Drug: PF-06650833 Drug: PF-06651600
PF-06650833	Experimental	Drug: PF-06650833
PF-06651600	Experimental	Drug: PF-06651600
Tofacitinib	Experimental	Drug: Tofacitinib

Name	Type	Description	Arm Group Labels	Other Names
PF-06650833	Drug	400 mg	PF-06650833 PF-06650833 + PF-06651600 PF-06650833 + tofacitinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12

Secondary Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

Eligibility Criteria

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.](streamdown:incomplete-link)

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
,,UMHAT - Georgi Stranski" EAD		Pleven		5800	Bulgaria
Medical Diagnostic Laboratory Rusev EOOD

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Tofacitinib 11mg MR	Participants received tofacitinib 11mg as modified release (MR) tablets once daily (QD).
FG001	PF-06651600 100mg	Participants received PF-06651600 100mg tablets QD.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 10, 2022	Feb 6, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Least Squares Mean

90% Confidence Interval

Units on a scale

BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12

ID	Title	Description
OG000	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
OG001	PF-06650833 400mg MR + PF-06651600 100mg	Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
OG002	Tofacitinib 11mg MR	Participants who received tofacitinib 11mg MR
OG003	PF-06651600 100mg	Participants who received PF-06651600 100mg
OG004	PF-06650833 400mg MR	Participants who received PF-06650833 400mg MR

Units	Counts
Participants	OG00096 OG00193 OG00296 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.65(-2.84 to -2.46) OG001-2.35(-2.54 to -2.15) OG002-2.30(-2.49 to -2.11) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	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.	Mixed Model Repeated Measures		0.0158		Mean Difference (Final Values)	-0.35	Standard Error of the Mean	0.163	2-Sided	90	-0.62	-0.08					Superiority

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)

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.

Posted

Number

90% Confidence Interval

Percentage of participants

Week 24

ID	Title	Description
OG000	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
OG001	PF-06650833 400mg MR + PF-06651600 100mg	Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
OG002	Tofacitinib 11mg MR	Participants who received tofacitinib 11mg MR

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.

The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From first dose of study intervention (Day 1) to Week 28

ID	Title	Description
OG000	Tofacitinib 11mg MR	Participants who received tofacitinib 11mg MR
OG001	PF-06651600 100mg	Participants who received PF-06651600 100mg

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.

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.

Posted

Count of Participants

Participants

From BL to Week 28

ID	Title	Description
OG000	Tofacitinib 11mg MR	Participants who received tofacitinib 11mg MR
OG001	PF-06651600 100mg	Participants who received PF-06651600 100mg
OG002	PF-06650833 400mg MR	Participants who received PF-06650833 400mg MR
OG003	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR

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

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.

Posted

Count of Participants

Participants

From BL to Week 28

ID	Title	Description
OG000	Tofacitinib 11mg MR	Participants who received tofacitinib 11mg MR
OG001	PF-06651600 100mg	Participants who received PF-06651600 100mg
OG002	PF-06650833 400mg MR	Participants who received PF-06650833 400mg MR
OG003	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR

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.

The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Posted

Count of Participants

Participants

From first dose of study intervention (Day 1) to Week 28

ID	Title	Description
OG000	Tofacitinib 11mg MR	Participants who received tofacitinib 11mg MR
OG001	PF-06651600 100mg	Participants who received PF-06651600 100mg
OG002	PF-06650833 400mg MR	Participants who received PF-06650833 400mg MR

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.

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.

Posted

Least Squares Mean

90% Confidence Interval

Units on a scale

BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24

ID	Title	Description
OG000	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
OG001	PF-06650833 400mg MR + PF-06651600 100mg	Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg

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)

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.

Posted

Number

90% Confidence Interval

Percentage of participants

BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

ID	Title	Description
OG000	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
OG001	PF-06650833 400mg MR + PF-06651600 100mg	Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg

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.

Posted

Least Squares Mean

90% Confidence Interval

Joints

BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

ID	Title	Description
OG000	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
OG001	PF-06650833 400mg MR + PF-06651600 100mg

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.

Posted

Least Squares Mean

90% Confidence Interval

Units on a scale

BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

ID	Title	Description
OG000	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR
OG001	PF-06650833 400mg MR + PF-06651600 100mg	Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg
OG002

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19 pneumonia	Infections and infestations	MedDRA v24.1	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected77 at risk EG0020 affected77 at risk EG0030 affected103 at risk EG0041 affected101 at risk
Coronavirus infection	Infections and infestations	MedDRA v24.1	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected77 at risk EG0020 affected77 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA v24.1	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected77 at risk EG0020 affected77 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v24.1	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected77 at risk EG0020 affected77 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v24.1	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected77 at risk EG0021 affected77 at risk EG003
Skin squamous cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.1	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected77 at risk EG0020 affected77 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.1	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected77 at risk EG0020 affected77 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA v24.1	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected77 at risk EG0021 affected77 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA v24.1	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected77 at risk EG0021 affected77 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA v24.1	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected77 at risk EG0021 affected77 at risk EG003

ID	Title	Description
BG000	Tofacitinib 11mg MR	Participants received tofacitinib 11mg MR tablets QD.
BG001	PF-06651600 100mg	Participants received PF-06651600 100mg tablets QD.
BG002	PF-06650833 400mg MR	Participants received PF-06650833 400mg as MR tablets QD.
BG003	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.
BG004	PF-06650833 400mg MR + PF-06651600 100mg	Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.
BG005	Total	Total of all reporting groups

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tofacitinib 11mg MR	Participants received tofacitinib 11mg MR tablets QD.	1	102	3	102	24	102
EG001	PF-06651600 100mg	Participants received PF-06651600 100mg tablets QD.	0	77	3	77	18	77
EG002	PF-06650833 400mg MR	Participants received PF-06650833 400mg MR tablets QD.	0	77	3	77	11	77
EG003	PF-06650833 400mg MR + Tofacitinib 11mg MR	Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.	0	103	0	103	19	103
EG004	PF-06650833 400mg MR + PF-06651600 100mg	Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.	0	101	1	101	26	101

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA v24.1	Non-systematic Assessment	EG0004 affected102 at risk EG0015 affected77 at risk EG0022 affected77 at risk EG0031 affected103 at risk EG0043 affected101 at risk
Nasopharyngitis	Infections and infestations	MedDRA v24.1	Non-systematic Assessment	EG0003 affected102 at risk EG0012 affected77 at risk EG0021 affected77 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v24.1	Non-systematic Assessment	EG0005 affected102 at risk EG0011 affected77 at risk EG0021 affected77 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA v24.1	Non-systematic Assessment	EG0007 affected102 at risk EG0011 affected77 at risk EG0022 affected77 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v24.1	Non-systematic Assessment	EG0003 affected102 at risk EG0015 affected77 at risk EG0021 affected77 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA v24.1	Non-systematic Assessment	EG0003 affected102 at risk EG0014 affected77 at risk EG0024 affected77 at risk EG003
Headache	Nervous system disorders	MedDRA v24.1	Non-systematic Assessment	EG0004 affected102 at risk EG0014 affected77 at risk EG0022 affected77 at risk EG003

ID	Term
C000621967	1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide
C000614924	PF-06651600
C479163	tofacitinib