Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02969044
• Collaborator: (none)
• Enrollment: 70
• Locations: 30
• Arms: 2
• Actual Duration (Months): 11.7
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Placebo; Drug: PF-06651600	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate
• Actual Study Start Date: Dec 20, 2016
• Actual Primary Completion Date: Dec 12, 2017
• Actual Study Completion Date: Dec 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-06651600 Study Drug	Drug: PF-06651600; 200mg pill every day (QD) for 8 weeks
Placebo Comparator: Placebo Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 [Baseline, Week 8]

   The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (<=) 3.3 indicates disease remission, greater than (>) 3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.

Secondary Outcome Measures

1. Number of Participants With Vital Signs Abnormalities [Baseline up to Week 12]

   Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.

2. Number of Participants With Laboratory Abnormalities [Baseline up to Week 12]

   Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholesterol:<0.8*LLN or >1.2*ULN;urea nitrogen;creatinine: >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride;calcium; bicarbonate:<0.9*LLN or >1.1*ULN,glucose <0.6*LLN or >1.5*ULN, creatine kinase: >2.0*ULN;urine pH <4.5 or >8,urine glucose or ketones>=1,urine protein;urineHb>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase >=1,urine erythrocytes, leukocytes>=20,hyaline cast>1,bacteria>20.

3. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 12]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.

4. Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 [Baseline, Week 1, 2, 4 and 6]

   The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.

5. Remission Rate Based on Simple Disease Activity Index Score [Week 4, 6 and 8]

   Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.

6. Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) [Week 4, 6 and 8]

   Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.

7. Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) [Week 4, 6 and 8]

   Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

8. Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) [Week 4, 6 and 8]

   Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.

9. Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) [Week 4, 6 and 8]

   Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.

10. Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6 and 8]

    DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.

11. Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6 and 8]

    DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

12. Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6 and 8]

    DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.

13. Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6 and 8]

    DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.

14. Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6 and 8]

15. Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6 and 8]

    Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.

16. Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6 and 8]

    PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.

17. Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6 and 8]

    HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Subjects between the ages of 18 and 75 years, inclusive

• Must have moderate-to-severe, active Rheumatoid Arthritis

• Must have had an inadequate response to Methotrexate

• Subjects may have received one approved TNF inhibiting biologic agent that was inadequately effective and/or not tolerated

Exclusion Criteria

• Subjects with any acute or chronic infections or infection history

• Have acute or active chronic dermatological disorders prior to study start

• Any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study

• Known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency

• Any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Medical Research Associates Inc.	Northridge	California	United States	91324
2	Clayton Medical Associates, PC	Saint Louis	Missouri	United States	63117
3	Altoona Center For Clinical Research	Duncansville	Pennsylvania	United States	16635
4	Southwest Rheumatology Research, LLC	Mesquite	Texas	United States	75150
5	MHAT "Trimontsium" Department of Internal Diseases	Plovdiv		Bulgaria	4000
6	UMHAT Kaspela, Clinic of Rheumatology	Plovdiv		Bulgaria	4001
7	Medical Centre "Pirogov"	Sofia		Bulgaria	1606
8	Medical Center Equita	Varna		Bulgaria	9000
9	Medical Center "Sveti Ivan Rilski"	Vidin		Bulgaria	3700
10	MEDICAL PLUS, s.r.o.	Uherske Hradiste		Czechia	686 01
11	LTD "Unimed Ajara" Batumi Referral Hospital	Batumi		Georgia	6010
12	LTD Israeli-Georgian Medical Research Clinic ,,Helsicore"	Tbilisi		Georgia	0112
13	Ltd Institute of Clinical Cardiology	Tbilisi		Georgia	0159
14	LTD Unimedi Kakheti	Tbilisi		Georgia	0159
15	ISA - Interdisciplinary Study Association GmbH	Berlin		Germany	10789
16	Rheumatologische Schwerpunktpraxis	Berlin		Germany	12161
17	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly	Nyiregyhaza		Hungary	H-4400
18	NZOZ Centrum Medyczne Sw. Lukasza w Kartuzach	Kartuzy		Poland	83-300
19	Care Clinic Sp. z o.o.	Katowice		Poland	40-060
20	Silmedic Sp. z o.o. Oddzial w Katowicach	Katowice		Poland	40-282
21	Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.	Oswiecim		Poland	32-600
22	Centrum Medyczne Oporow	Wroclaw		Poland	52-416
23	Clinic of Dermatovenerology "Prof. Zecevic"	Belgrade		Serbia	11000
24	Institute of Rheumatology	Belgrade		Serbia	11000
25	Polyclinic Medikom	Belgrade		Serbia	11000
26	Institute of Treatment and Rehabilitation "Niska Banja"	Niska Banja		Serbia	18205
27	AAGS s.r.o., Reumatologicka ambulancia	Dunajska Streda		Slovakia	92901
28	MUDr. Zuzana Cizmarikova s.r.o. , Reumatologicka ambulancia	Poprad		Slovakia	058 01
29	Nestatna reumatologicka ambulancia	Povazska Bystrica		Slovakia	017 01
30	Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.	Zilina		Slovakia	01001

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Oct 26, 2016
• Statistical Analysis Plan - Jan 18, 2018

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02969044
• Other Study ID Numbers: B7981006; 2016-002862-30
• First Posted: Nov 21, 2016
• Last Update Posted: Dec 4, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

Participant Flow

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 milligram (mg) of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Period Title: Overall Study
STARTED	42	28
COMPLETED	37	22
NOT COMPLETED	5	6

Baseline Characteristics

Arm/Group Title	PF-06651600	Placebo	Total
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Total of all reporting groups
Overall Participants	42	28	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (11.72)	54.2 (11.78)	54.9 (11.67)
Sex: Female, Male (Count of Participants)
Female	33 78.6%	24 85.7%	57 81.4%
Male	9 21.4%	4 14.3%	13 18.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.4%	2 7.1%	3 4.3%
Not Hispanic or Latino	41 97.6%	26 92.9%	67 95.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.4%	0 0%	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	41 97.6%	28 100%	69 98.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
Description	The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (<=) 3.3 indicates disease remission, greater than (>) 3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline	45.15 (13.164)	44.85 (13.976)
Change at Week 8	-26.11 (14.834)	-17.38 (18.176)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-06651600, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.25
	Confidence Interval	(2-Sided) 95%; -14.75 to -3.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Vital Signs Abnormalities
Description	Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study drug.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Sitting DBP >=20 mmHg increase from baseline	3 7.1%	0 0%
Sitting DBP >=20 mmHg decrease from baseline	0 0%	1 3.6%

3. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities
Description	Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholesterol:<0.8*LLN or >1.2*ULN;urea nitrogen;creatinine: >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride;calcium; bicarbonate:<0.9*LLN or >1.1*ULN,glucose <0.6*LLN or >1.5*ULN, creatine kinase: >2.0*ULN;urine pH <4.5 or >8,urine glucose or ketones>=1,urine protein;urineHb>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase >=1,urine erythrocytes, leukocytes>=20,hyaline cast>1,bacteria>20.
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study drug.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Count of Participants [Participants]	42 100%	28 100%

4. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study drug.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
AEs	20 47.6%	5 17.9%
SAEs	0 0%	0 0%

5. Secondary Outcome

Title	Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6
Description	The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame	Baseline, Week 1, 2, 4 and 6

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Change at Week 1	-4.59 (9.409)	-4.52 (7.025)
Change at Week 2	-12.82 (10.969)	-8.05 (9.402)
Change at Week 4	-17.79 (12.804)	-12.55 (13.462)
Change at Week 6	-22.79 (14.007)	-15.62 (14.231)

6. Secondary Outcome

Title	Remission Rate Based on Simple Disease Activity Index Score
Description	Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame	Week 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Week 4	4.8 11.4%	0.0 0%
Week 6	4.8 11.4%	0.0 0%
Week 8	7.1 16.9%	0.0 0%

7. Secondary Outcome

Title	Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
Description	Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
Time Frame	Week 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Week 4	4.8 11.4%	0.0 0%
Week 6	2.4 5.7%	0.0 0%
Week 8	7.1 16.9%	0.0 0%

8. Secondary Outcome

Title	Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
Description	Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Time Frame	Week 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Week 4	4.8 11.4%	0.0 0%
Week 6	4.8 11.4%	0.0 0%
Week 8	7.1 16.9%	0.0 0%

9. Secondary Outcome

Title	Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
Description	Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame	Week 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Week 4	9.5 22.6%	0.0 0%
Week 6	7.1 16.9%	3.6 12.9%
Week 8	9.5 22.6%	0.0 0%

10. Secondary Outcome

Title	Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
Description	Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
Time Frame	Week 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Week 4	9.5 22.6%	0.0 0%
Week 6	9.5 22.6%	3.6 12.9%
Week 8	9.5 22.6%	0.0 0%

11. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8
Description	DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
Time Frame	Baseline, Week 1, 2, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline	6.49 (0.762)	6.37 (0.815)
Change at Week 1	-0.19 (0.604)	-0.26 (0.434)
Change at Week 2	-0.67 (0.602)	-0.46 (0.531)
Change at Week 4	-1.16 (1.125)	-0.78 (0.905)
Change at Week 6	-1.54 (1.123)	-1.07 (0.989)
Change at Week 8	-1.85 (1.161)	-1.07 (1.214)

12. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8
Description	DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Time Frame	Baseline, Week 1, 2, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline	6.82 (0.815)	6.72 (0.880)
Change at Week 1	-0.27 (0.553)	-0.27 (0.477)
Change at Week 2	-0.83 (0.695)	-0.47 (0.551)
Change at Week 4	-1.36 (1.173)	-0.89 (0.951)
Change at Week 6	-1.81 (1.179)	-1.18 (1.050)
Change at Week 8	-2.14 (1.269)	-1.22 (1.448)

13. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8
Description	DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame	Baseline, Week 1, 2, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline	5.76 (0.824)	5.61 (0.894)
Change at Week 1	-0.35 (0.741)	-0.20 (0.456)
Change at Week 2	-0.86 (0.782)	-0.47 (0.585)
Change at Week 4	-1.33 (1.219)	-0.72 (1.005)
Change at Week 6	-1.53 (1.286)	-1.01 (0.993)
Change at Week 8	-1.79 (1.265)	-1.03 (1.146)

14. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8
Description	DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
Time Frame	Baseline, Week 1, 2, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline	6.11 (0.850)	5.98 (0.926)
Change at Week 1	-0.41 (0.685)	-0.21 (0.473)
Change at Week 2	-0.99 (0.823)	-0.47 (0.574)
Change at Week 4	-1.49 (1.222)	-0.82 (1.013)
Change at Week 6	-1.78 (1.304)	-1.09 (1.057)
Change at Week 8	-2.06 (1.321)	-1.16 (1.367)

15. Secondary Outcome

Title	Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8
Time Frame	Baseline, Week 1, 2, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline	2.00 (1.816)	1.68 (2.853)
Change at Week 1	-0.20 (2.672)	0.60 (2.263)
Change at Week 2	-0.62 (2.090)	-0.04 (0.966)
Change at Week 4	-0.93 (1.591)	0.00 (1.335)
Change at Week 6	-0.42 (2.376)	-0.23 (1.327)
Change at Week 8	-0.89 (2.142)	-0.04 (2.220)

16. Secondary Outcome

Title	Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8
Description	Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Time Frame	Baseline, Week 1, 2, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline: Tender joint count	16.74 (6.765)	16.75 (6.681)
Baseline: Swollen joint count	12.95 (5.396)	12.11 (6.160)
Change at Week 1: Tender joint count	-1.54 (4.915)	-1.96 (2.701)
Change at Week 1: Swollen joint count	-1.49 (4.439)	-2.46 (3.501)
Change at Week 2: Tender joint count	-4.40 (5.522)	-2.56 (5.213)
Change at Week 2: Swollen joint count	-4.71 (4.430)	-4.11 (4.619)
Change at Week 4: Tender joint count	-6.76 (6.818)	-4.96 (7.750)
Change at Week 4: Swollen joint count	-5.95 (4.950)	-4.85 (4.961)
Change at Week 6: Tender joint count	-8.75 (7.132)	-6.42 (6.652)
Change at Week 6: Swollen joint count	-7.80 (5.743)	-5.85 (5.540)
Change at Week 8: Tender joint count	-10.21 (7.259)	-6.83 (7.755)
Change at Week 8: Swollen joint count	-8.59 (6.176)	-6.54 (6.324)

17. Secondary Outcome

Title	Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8
Description	PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Time Frame	Baseline, Week 1, 2, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline: PAAP	66.64 (16.771)	71.75 (16.183)
Baseline: PGA	68.43 (15.639)	69.00 (16.115)
Baseline: PGAA	66.17 (14.228)	74.07 (12.844)
Change at Week 1: PAAP	-4.95 (11.388)	-2.86 (14.847)
Change at Week 1: PGA	-6.76 (11.128)	-1.93 (9.149)
Change at Week 1: PGAA	-6.83 (8.947)	-4.96 (8.126)
Change at Week 2: PAAP	-11.90 (18.061)	-6.04 (12.669)
Change at Week 2: PGA	-14.74 (15.963)	-2.81 (9.931)
Change at Week 2: PGAA	-16.07 (16.499)	-10.63 (12.500)
Change at Week 4: PAAP	-19.88 (16.695)	-10.23 (25.513)
Change at Week 4: PGA	-20.05 (13.746)	-12.12 (19.574)
Change at Week 4: PGAA	-21.49 (16.715)	-17.96 (18.877)
Change at Week 6: PAAP	-27.90 (20.061)	-12.35 (27.425)
Change at Week 6: PGA	-27.83 (18.936)	-11.65 (21.630)
Change at Week 6: PGAA	-30.45 (17.868)	-19.50 (22.963)
Change at Week 8: PAAP	-32.92 (25.051)	-18.58 (34.152)
Change at Week 8: PGA	-30.92 (21.279)	-15.88 (30.135)
Change at Week 8: PGAA	-33.28 (18.725)	-23.75 (25.902)

18. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8
Description	HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Time Frame	Baseline, Week 1, 2, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.

Arm/Group Title	PF-06651600	Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.	Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
Measure Participants	42	28
Baseline	1.79 (0.577)	1.69 (0.550)
Change at Week 1	-0.13 (0.391)	-0.04 (0.316)
Change at Week 2	-0.26 (0.430)	-0.15 (0.347)
Change at Week 4	-0.39 (0.414)	-0.19 (0.534)
Change at Week 6	-0.46 (0.527)	-0.23 (0.609)
Change at Week 8	-0.53 (0.583)	-0.32 (0.671)

Adverse Events

Time Frame	Baseline up to Week 12
Adverse Event Reporting Description	Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Arm/Group Title	PF-06651600		Placebo
Arm/Group Description	Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.		Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.
All Cause Mortality
	PF-06651600		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/28 (0%)
Serious Adverse Events
	PF-06651600		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	PF-06651600		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/42 (47.6%)		5/28 (17.9%)
Blood and lymphatic system disorders
Lymphopenia	3/42 (7.1%)		0/28 (0%)
Gastrointestinal disorders
Abdominal distension	1/42 (2.4%)		0/28 (0%)
Glossitis	1/42 (2.4%)		0/28 (0%)
Nausea	1/42 (2.4%)		0/28 (0%)
Vomiting	1/42 (2.4%)		0/28 (0%)
General disorders
Fatigue	1/42 (2.4%)		0/28 (0%)
Oedema peripheral	1/42 (2.4%)		0/28 (0%)
Hepatobiliary disorders
Hepatotoxicity	1/42 (2.4%)		0/28 (0%)
Infections and infestations
Asymptomatic bacteriuria	1/42 (2.4%)		0/28 (0%)
Fungal skin infection	1/42 (2.4%)		0/28 (0%)
Influenza	3/42 (7.1%)		0/28 (0%)
Oral herpes	1/42 (2.4%)		0/28 (0%)
Upper respiratory tract infection	0/42 (0%)		1/28 (3.6%)
Injury, poisoning and procedural complications
Fall	1/42 (2.4%)		0/28 (0%)
Ligament sprain	1/42 (2.4%)		0/28 (0%)
Investigations
Alanine aminotransferase increased	0/42 (0%)		1/28 (3.6%)
Aspartate aminotransferase increased	0/42 (0%)		1/28 (3.6%)
Blood creatine phosphokinase increased	1/42 (2.4%)		0/28 (0%)
Cytomegalovirus test positive	1/42 (2.4%)		0/28 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/42 (2.4%)		0/28 (0%)
Spinal pain	0/42 (0%)		1/28 (3.6%)
Synovitis	1/42 (2.4%)		0/28 (0%)
Nervous system disorders
Headache	0/42 (0%)		3/28 (10.7%)
Psychiatric disorders
Suicidal ideation	1/42 (2.4%)		0/28 (0%)
Skin and subcutaneous tissue disorders
Acne	1/42 (2.4%)		0/28 (0%)
Dermatitis	1/42 (2.4%)		0/28 (0%)
Pruritus	2/42 (4.8%)		1/28 (3.6%)
Rash maculo-papular	1/42 (2.4%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.