Rheumatoid Arthritis
Conditions
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).
Interventions
DRUGPlacebo
DRUGPF-06651600
200mg pill every day (QD) for 8 weeks
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 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 | — |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Bulgaria, Czechia, Georgia, Germany, Hungary, Poland, Serbia, Slovakia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-06651600 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. | 42 |
| Placebo 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. | 28 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | Placebo | Total | PF-06651600 |
|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 11.78 | 54.9 years STANDARD_DEVIATION 11.67 | 55.4 years STANDARD_DEVIATION 11.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 67 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 69 Participants | 41 Participants |
| Sex: Female, Male Female | 24 Participants | 57 Participants | 33 Participants |
| Sex: Female, Male Male | 4 Participants | 13 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 28 |
| other Total, other adverse events | 20 / 42 | 5 / 28 |
| serious Total, serious adverse events | 0 / 42 | 0 / 28 |
Outcome results
Primary
Change From Baseline in Simple Disease Activity Index (SDAI) Score at 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.
Time frame: Baseline, Week 8
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | Baseline | 45.15 units on a scale | Standard Deviation 13.164 |
| PF-06651600 | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | Change at Week 8 | -26.11 units on a scale | Standard Deviation 14.834 |
| Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | Baseline | 44.85 units on a scale | Standard Deviation 13.976 |
| Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | Change at Week 8 | -17.38 units on a scale | Standard Deviation 18.176 |
p-value: <0.00195% CI: [-14.75, -3.79]ANCOVA
Secondary
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
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | 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 | 5.76 units on a scale | Standard Deviation 0.824 |
| PF-06651600 | 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 | Change at Week 1 | -0.35 units on a scale | Standard Deviation 0.741 |
| PF-06651600 | 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 | Change at Week 2 | -0.86 units on a scale | Standard Deviation 0.782 |
| PF-06651600 | 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 | Change at Week 4 | -1.33 units on a scale | Standard Deviation 1.219 |
| PF-06651600 | 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 | Change at Week 6 | -1.53 units on a scale | Standard Deviation 1.286 |
| PF-06651600 | 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 | Change at Week 8 | -1.79 units on a scale | Standard Deviation 1.265 |
| Placebo | 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 | Change at Week 6 | -1.01 units on a scale | Standard Deviation 0.993 |
| Placebo | 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 | 5.61 units on a scale | Standard Deviation 0.894 |
| Placebo | 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 | Change at Week 4 | -0.72 units on a scale | Standard Deviation 1.005 |
| Placebo | 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 | Change at Week 1 | -0.20 units on a scale | Standard Deviation 0.456 |
| Placebo | 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 | Change at Week 8 | -1.03 units on a scale | Standard Deviation 1.146 |
| Placebo | 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 | Change at Week 2 | -0.47 units on a scale | Standard Deviation 0.585 |
Secondary
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
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | 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 | 6.11 units on a scale | Standard Deviation 0.85 |
| PF-06651600 | 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 | Change at Week 1 | -0.41 units on a scale | Standard Deviation 0.685 |
| PF-06651600 | 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 | Change at Week 2 | -0.99 units on a scale | Standard Deviation 0.823 |
| PF-06651600 | 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 | Change at Week 4 | -1.49 units on a scale | Standard Deviation 1.222 |
| PF-06651600 | 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 | Change at Week 6 | -1.78 units on a scale | Standard Deviation 1.304 |
| PF-06651600 | 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 | Change at Week 8 | -2.06 units on a scale | Standard Deviation 1.321 |
| Placebo | 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 | Change at Week 6 | -1.09 units on a scale | Standard Deviation 1.057 |
| Placebo | 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 | 5.98 units on a scale | Standard Deviation 0.926 |
| Placebo | 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 | Change at Week 4 | -0.82 units on a scale | Standard Deviation 1.013 |
| Placebo | 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 | Change at Week 1 | -0.21 units on a scale | Standard Deviation 0.473 |
| Placebo | 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 | Change at Week 8 | -1.16 units on a scale | Standard Deviation 1.367 |
| Placebo | 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 | Change at Week 2 | -0.47 units on a scale | Standard Deviation 0.574 |
Secondary
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
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | 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 | Change at Week 1 | -0.19 units on a scale | Standard Deviation 0.604 |
| PF-06651600 | 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 | Change at Week 4 | -1.16 units on a scale | Standard Deviation 1.125 |
| PF-06651600 | 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 | 6.49 units on a scale | Standard Deviation 0.762 |
| PF-06651600 | 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 | Change at Week 2 | -0.67 units on a scale | Standard Deviation 0.602 |
| PF-06651600 | 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 | Change at Week 8 | -1.85 units on a scale | Standard Deviation 1.161 |
| PF-06651600 | 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 | Change at Week 6 | -1.54 units on a scale | Standard Deviation 1.123 |
| Placebo | 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 | Change at Week 8 | -1.07 units on a scale | Standard Deviation 1.214 |
| Placebo | 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 | 6.37 units on a scale | Standard Deviation 0.815 |
| Placebo | 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 | Change at Week 1 | -0.26 units on a scale | Standard Deviation 0.434 |
| Placebo | 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 | Change at Week 2 | -0.46 units on a scale | Standard Deviation 0.531 |
| Placebo | 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 | Change at Week 4 | -0.78 units on a scale | Standard Deviation 0.905 |
| Placebo | 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 | Change at Week 6 | -1.07 units on a scale | Standard Deviation 0.989 |
Secondary
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
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | 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 | 6.82 units on a scale | Standard Deviation 0.815 |
| PF-06651600 | 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 | Change at Week 1 | -0.27 units on a scale | Standard Deviation 0.553 |
| PF-06651600 | 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 | Change at Week 2 | -0.83 units on a scale | Standard Deviation 0.695 |
| PF-06651600 | 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 | Change at Week 4 | -1.36 units on a scale | Standard Deviation 1.173 |
| PF-06651600 | 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 | Change at Week 6 | -1.81 units on a scale | Standard Deviation 1.179 |
| PF-06651600 | 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 | Change at Week 8 | -2.14 units on a scale | Standard Deviation 1.269 |
| Placebo | 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 | Change at Week 6 | -1.18 units on a scale | Standard Deviation 1.05 |
| Placebo | 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 | 6.72 units on a scale | Standard Deviation 0.88 |
| Placebo | 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 | Change at Week 4 | -0.89 units on a scale | Standard Deviation 0.951 |
| Placebo | 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 | Change at Week 1 | -0.27 units on a scale | Standard Deviation 0.477 |
| Placebo | 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 | Change at Week 8 | -1.22 units on a scale | Standard Deviation 1.448 |
| Placebo | 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 | Change at Week 2 | -0.47 units on a scale | Standard Deviation 0.551 |
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at 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.
Time frame: Baseline, Week 1, 2, 4, 6 and 8
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Baseline | 1.79 units on a scale | Standard Deviation 0.577 |
| PF-06651600 | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 1 | -0.13 units on a scale | Standard Deviation 0.391 |
| PF-06651600 | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 2 | -0.26 units on a scale | Standard Deviation 0.43 |
| PF-06651600 | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 4 | -0.39 units on a scale | Standard Deviation 0.414 |
| PF-06651600 | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 6 | -0.46 units on a scale | Standard Deviation 0.527 |
| PF-06651600 | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 8 | -0.53 units on a scale | Standard Deviation 0.583 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 6 | -0.23 units on a scale | Standard Deviation 0.609 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Baseline | 1.69 units on a scale | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 4 | -0.19 units on a scale | Standard Deviation 0.534 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 1 | -0.04 units on a scale | Standard Deviation 0.316 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 8 | -0.32 units on a scale | Standard Deviation 0.671 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 | Change at Week 2 | -0.15 units on a scale | Standard Deviation 0.347 |
Secondary
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 1 | -0.20 milligram per deciliter | Standard Deviation 2.672 |
| PF-06651600 | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 4 | -0.93 milligram per deciliter | Standard Deviation 1.591 |
| PF-06651600 | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 6 | -0.42 milligram per deciliter | Standard Deviation 2.376 |
| PF-06651600 | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Baseline | 2.00 milligram per deciliter | Standard Deviation 1.816 |
| PF-06651600 | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 8 | -0.89 milligram per deciliter | Standard Deviation 2.142 |
| PF-06651600 | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 2 | -0.62 milligram per deciliter | Standard Deviation 2.09 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 8 | -0.04 milligram per deciliter | Standard Deviation 2.22 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Baseline | 1.68 milligram per deciliter | Standard Deviation 2.853 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 1 | 0.60 milligram per deciliter | Standard Deviation 2.263 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 2 | -0.04 milligram per deciliter | Standard Deviation 0.966 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 6 | -0.23 milligram per deciliter | Standard Deviation 1.327 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 | Change at Week 4 | 0.00 milligram per deciliter | Standard Deviation 1.335 |
Secondary
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
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | 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 | Change at Week 2: PGA | -14.74 units on a scale | Standard Deviation 15.963 |
| PF-06651600 | 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 | Change at Week 2: PGAA | -16.07 units on a scale | Standard Deviation 16.499 |
| PF-06651600 | 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 | Change at Week 4: PAAP | -19.88 units on a scale | Standard Deviation 16.695 |
| PF-06651600 | 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 | Change at Week 4: PGA | -20.05 units on a scale | Standard Deviation 13.746 |
| PF-06651600 | 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 | Change at Week 4: PGAA | -21.49 units on a scale | Standard Deviation 16.715 |
| PF-06651600 | 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 | Change at Week 6: PAAP | -27.90 units on a scale | Standard Deviation 20.061 |
| PF-06651600 | 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: PAAP | 66.64 units on a scale | Standard Deviation 16.771 |
| PF-06651600 | 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 | Change at Week 6: PGA | -27.83 units on a scale | Standard Deviation 18.936 |
| PF-06651600 | 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 | Change at Week 6: PGAA | -30.45 units on a scale | Standard Deviation 17.868 |
| PF-06651600 | 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 | Change at Week 8: PAAP | -32.92 units on a scale | Standard Deviation 25.051 |
| PF-06651600 | 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: PGA | 68.43 units on a scale | Standard Deviation 15.639 |
| PF-06651600 | 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 | Change at Week 8: PGA | -30.92 units on a scale | Standard Deviation 21.279 |
| PF-06651600 | 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: PGAA | 66.17 units on a scale | Standard Deviation 14.228 |
| PF-06651600 | 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 | Change at Week 8: PGAA | -33.28 units on a scale | Standard Deviation 18.725 |
| PF-06651600 | 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 | Change at Week 1: PAAP | -4.95 units on a scale | Standard Deviation 11.388 |
| PF-06651600 | 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 | Change at Week 1: PGA | -6.76 units on a scale | Standard Deviation 11.128 |
| PF-06651600 | 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 | Change at Week 1: PGAA | -6.83 units on a scale | Standard Deviation 8.947 |
| PF-06651600 | 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 | Change at Week 2: PAAP | -11.90 units on a scale | Standard Deviation 18.061 |
| Placebo | 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 | Change at Week 1: PAAP | -2.86 units on a scale | Standard Deviation 14.847 |
| Placebo | 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 | Change at Week 8: PAAP | -18.58 units on a scale | Standard Deviation 34.152 |
| Placebo | 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 | Change at Week 2: PGAA | -10.63 units on a scale | Standard Deviation 12.5 |
| Placebo | 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 | Change at Week 2: PGA | -2.81 units on a scale | Standard Deviation 9.931 |
| Placebo | 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 | Change at Week 4: PAAP | -10.23 units on a scale | Standard Deviation 25.513 |
| Placebo | 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: PGA | 69.00 units on a scale | Standard Deviation 16.115 |
| Placebo | 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 | Change at Week 4: PGA | -12.12 units on a scale | Standard Deviation 19.574 |
| Placebo | 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 | Change at Week 1: PGA | -1.93 units on a scale | Standard Deviation 9.149 |
| Placebo | 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 | Change at Week 4: PGAA | -17.96 units on a scale | Standard Deviation 18.877 |
| Placebo | 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: PGAA | 74.07 units on a scale | Standard Deviation 12.844 |
| Placebo | 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 | Change at Week 6: PAAP | -12.35 units on a scale | Standard Deviation 27.425 |
| Placebo | 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 | Change at Week 8: PGA | -15.88 units on a scale | Standard Deviation 30.135 |
| Placebo | 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 | Change at Week 2: PAAP | -6.04 units on a scale | Standard Deviation 12.669 |
| Placebo | 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 | Change at Week 6: PGA | -11.65 units on a scale | Standard Deviation 21.63 |
| Placebo | 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: PAAP | 71.75 units on a scale | Standard Deviation 16.183 |
| Placebo | 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 | Change at Week 8: PGAA | -23.75 units on a scale | Standard Deviation 25.902 |
| Placebo | 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 | Change at Week 6: PGAA | -19.50 units on a scale | Standard Deviation 22.963 |
| Placebo | 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 | Change at Week 1: PGAA | -4.96 units on a scale | Standard Deviation 8.126 |
Secondary
Change From Baseline in Simple Disease Activity Index (SDAI) Score at 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.
Time frame: Baseline, Week 1, 2, 4 and 6
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Change at Week 1 | -4.59 units on a scale | Standard Deviation 9.409 |
| PF-06651600 | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Change at Week 2 | -12.82 units on a scale | Standard Deviation 10.969 |
| PF-06651600 | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Change at Week 4 | -17.79 units on a scale | Standard Deviation 12.804 |
| PF-06651600 | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Change at Week 6 | -22.79 units on a scale | Standard Deviation 14.007 |
| Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Change at Week 6 | -15.62 units on a scale | Standard Deviation 14.231 |
| Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Change at Week 1 | -4.52 units on a scale | Standard Deviation 7.025 |
| Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Change at Week 4 | -12.55 units on a scale | Standard Deviation 13.462 |
| Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Change at Week 2 | -8.05 units on a scale | Standard Deviation 9.402 |
Secondary
Change From Baseline in the Tender Joint Count and Swollen Joint Count at 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.
Time frame: Baseline, Week 1, 2, 4, 6 and 8
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Baseline: Tender joint count | 16.74 joint count | Standard Deviation 6.765 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Baseline: Swollen joint count | 12.95 joint count | Standard Deviation 5.396 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 1: Tender joint count | -1.54 joint count | Standard Deviation 4.915 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 1: Swollen joint count | -1.49 joint count | Standard Deviation 4.439 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 2: Tender joint count | -4.40 joint count | Standard Deviation 5.522 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 2: Swollen joint count | -4.71 joint count | Standard Deviation 4.43 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 4: Tender joint count | -6.76 joint count | Standard Deviation 6.818 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 4: Swollen joint count | -5.95 joint count | Standard Deviation 4.95 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 6: Tender joint count | -8.75 joint count | Standard Deviation 7.132 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 6: Swollen joint count | -7.80 joint count | Standard Deviation 5.743 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 8: Tender joint count | -10.21 joint count | Standard Deviation 7.259 |
| PF-06651600 | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 8: Swollen joint count | -8.59 joint count | Standard Deviation 6.176 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 8: Tender joint count | -6.83 joint count | Standard Deviation 7.755 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Baseline: Tender joint count | 16.75 joint count | Standard Deviation 6.681 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 4: Tender joint count | -4.96 joint count | Standard Deviation 7.75 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Baseline: Swollen joint count | 12.11 joint count | Standard Deviation 6.16 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 6: Swollen joint count | -5.85 joint count | Standard Deviation 5.54 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 1: Tender joint count | -1.96 joint count | Standard Deviation 2.701 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 4: Swollen joint count | -4.85 joint count | Standard Deviation 4.961 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 1: Swollen joint count | -2.46 joint count | Standard Deviation 3.501 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 8: Swollen joint count | -6.54 joint count | Standard Deviation 6.324 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 2: Tender joint count | -2.56 joint count | Standard Deviation 5.213 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 6: Tender joint count | -6.42 joint count | Standard Deviation 6.652 |
| Placebo | Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 | Change at Week 2: Swollen joint count | -4.11 joint count | Standard Deviation 4.619 |
Secondary
Number of Participants With Laboratory Abnormalities
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
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06651600 | Number of Participants With Laboratory Abnormalities | 42 Participants |
| Placebo | Number of Participants With Laboratory Abnormalities | 28 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06651600 | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 20 Participants |
| PF-06651600 | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 5 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Number of Participants With Vital Signs Abnormalities
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
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06651600 | Number of Participants With Vital Signs Abnormalities | Sitting DBP >=20 mmHg increase from baseline | 3 Participants |
| PF-06651600 | Number of Participants With Vital Signs Abnormalities | Sitting DBP >=20 mmHg decrease from baseline | 0 Participants |
| Placebo | Number of Participants With Vital Signs Abnormalities | Sitting DBP >=20 mmHg increase from baseline | 0 Participants |
| Placebo | Number of Participants With Vital Signs Abnormalities | Sitting DBP >=20 mmHg decrease from baseline | 1 Participants |
Secondary
Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) | Week 4 | 9.5 percentage of participants |
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) | Week 6 | 7.1 percentage of participants |
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) | Week 8 | 9.5 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) | Week 4 | 0.0 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) | Week 6 | 3.6 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) | Week 8 | 0.0 percentage of participants |
Secondary
Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) | Week 4 | 4.8 percentage of participants |
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) | Week 6 | 2.4 percentage of participants |
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) | Week 8 | 7.1 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) | Week 4 | 0.0 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) | Week 6 | 0.0 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) | Week 8 | 0.0 percentage of participants |
Secondary
Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) | Week 4 | 9.5 percentage of participants |
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) | Week 6 | 9.5 percentage of participants |
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) | Week 8 | 9.5 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) | Week 4 | 0.0 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) | Week 6 | 3.6 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) | Week 8 | 0.0 percentage of participants |
Secondary
Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) | Week 4 | 4.8 percentage of participants |
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) | Week 6 | 4.8 percentage of participants |
| PF-06651600 | Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) | Week 8 | 7.1 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) | Week 4 | 0.0 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) | Week 6 | 0.0 percentage of participants |
| Placebo | Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) | Week 8 | 0.0 percentage of participants |
Secondary
Remission Rate Based on Simple Disease Activity Index Score
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06651600 | Remission Rate Based on Simple Disease Activity Index Score | Week 4 | 4.8 percentage of participants |
| PF-06651600 | Remission Rate Based on Simple Disease Activity Index Score | Week 6 | 4.8 percentage of participants |
| PF-06651600 | Remission Rate Based on Simple Disease Activity Index Score | Week 8 | 7.1 percentage of participants |
| Placebo | Remission Rate Based on Simple Disease Activity Index Score | Week 4 | 0.0 percentage of participants |
| Placebo | Remission Rate Based on Simple Disease Activity Index Score | Week 6 | 0.0 percentage of participants |
| Placebo | Remission Rate Based on Simple Disease Activity Index Score | Week 8 | 0.0 percentage of participants |