Trial Outcomes & Findings for Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate (NCT NCT02969044)
NCT ID: NCT02969044
Last Updated: 2018-12-04
Results Overview
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.
COMPLETED
PHASE2
70 participants
Baseline, Week 8
2018-12-04
Participant Flow
Participant milestones
| Measure |
PF-06651600
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
28
|
|
Overall Study
COMPLETED
|
37
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
PF-06651600
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Adverse Event
|
3
|
0
|
Baseline Characteristics
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Baseline characteristics by cohort
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
54.9 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
Baseline
|
45.15 units on a scale
Standard Deviation 13.164
|
44.85 units on a scale
Standard Deviation 13.976
|
|
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
|
-17.38 units on a scale
Standard Deviation 18.176
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Safety analysis set included all participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Number of Participants With Vital Signs Abnormalities
Sitting DBP >=20 mmHg increase from baseline
|
3 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Sitting DBP >=20 mmHg decrease from baseline
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Safety analysis set included all participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
42 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Safety analysis set included all participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
20 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 6Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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
|
-4.52 units on a scale
Standard Deviation 7.025
|
|
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
|
-8.05 units on a scale
Standard Deviation 9.402
|
|
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
|
-12.55 units on a scale
Standard Deviation 13.462
|
|
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
|
-15.62 units on a scale
Standard Deviation 14.231
|
SECONDARY outcome
Timeframe: Week 4, 6 and 8Population: 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).
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Remission Rate Based on Simple Disease Activity Index Score
Week 4
|
4.8 percentage of participants
|
0.0 percentage of participants
|
|
Remission Rate Based on Simple Disease Activity Index Score
Week 6
|
4.8 percentage of participants
|
0.0 percentage of participants
|
|
Remission Rate Based on Simple Disease Activity Index Score
Week 8
|
7.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 6 and 8Population: 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).
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
Week 6
|
2.4 percentage of participants
|
0.0 percentage of participants
|
|
Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
Week 4
|
4.8 percentage of participants
|
0.0 percentage of participants
|
|
Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
Week 8
|
7.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 6 and 8Population: 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).
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
Week 4
|
4.8 percentage of participants
|
0.0 percentage of participants
|
|
Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
Week 6
|
4.8 percentage of participants
|
0.0 percentage of participants
|
|
Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
Week 8
|
7.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 6 and 8Population: 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).
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
Week 4
|
9.5 percentage of participants
|
0.0 percentage of participants
|
|
Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
Week 6
|
7.1 percentage of participants
|
3.6 percentage of participants
|
|
Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
Week 8
|
9.5 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 6 and 8Population: 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).
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
Week 4
|
9.5 percentage of participants
|
0.0 percentage of participants
|
|
Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
Week 6
|
9.5 percentage of participants
|
3.6 percentage of participants
|
|
Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
Week 8
|
9.5 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6 and 8Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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
|
6.37 units on a scale
Standard Deviation 0.815
|
|
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
|
-0.26 units on a scale
Standard Deviation 0.434
|
|
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
|
-0.46 units on a scale
Standard Deviation 0.531
|
|
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
|
-0.78 units on a scale
Standard Deviation 0.905
|
|
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
|
-1.07 units on a scale
Standard Deviation 0.989
|
|
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
|
-1.07 units on a scale
Standard Deviation 1.214
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6 and 8Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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
|
6.72 units on a scale
Standard Deviation 0.880
|
|
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
|
-0.27 units on a scale
Standard Deviation 0.477
|
|
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
|
-0.47 units on a scale
Standard Deviation 0.551
|
|
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
|
-0.89 units on a scale
Standard Deviation 0.951
|
|
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
|
-1.18 units on a scale
Standard Deviation 1.050
|
|
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
|
-1.22 units on a scale
Standard Deviation 1.448
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6 and 8Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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
|
5.61 units on a scale
Standard Deviation 0.894
|
|
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
|
-0.20 units on a scale
Standard Deviation 0.456
|
|
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
|
-0.47 units on a scale
Standard Deviation 0.585
|
|
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
|
-0.72 units on a scale
Standard Deviation 1.005
|
|
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
|
-1.01 units on a scale
Standard Deviation 0.993
|
|
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
|
-1.03 units on a scale
Standard Deviation 1.146
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6 and 8Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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 0.850
|
5.98 units on a scale
Standard Deviation 0.926
|
|
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
|
-0.21 units on a scale
Standard Deviation 0.473
|
|
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
|
-0.47 units on a scale
Standard Deviation 0.574
|
|
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
|
-0.82 units on a scale
Standard Deviation 1.013
|
|
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
|
-1.09 units on a scale
Standard Deviation 1.057
|
|
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
|
-1.16 units on a scale
Standard Deviation 1.367
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6 and 8Population: 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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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 2.090
|
-0.04 milligram per deciliter
Standard Deviation 0.966
|
|
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
|
1.68 milligram per deciliter
Standard Deviation 2.853
|
|
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
|
0.60 milligram per deciliter
Standard Deviation 2.263
|
|
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
|
0.00 milligram per deciliter
Standard Deviation 1.335
|
|
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
|
-0.23 milligram per deciliter
Standard Deviation 1.327
|
|
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
|
-0.04 milligram per deciliter
Standard Deviation 2.220
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6 and 8Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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
|
16.75 joint count
Standard Deviation 6.681
|
|
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
|
12.11 joint count
Standard Deviation 6.160
|
|
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
|
-1.96 joint count
Standard Deviation 2.701
|
|
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
|
-2.46 joint count
Standard Deviation 3.501
|
|
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
|
-2.56 joint count
Standard Deviation 5.213
|
|
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 4.430
|
-4.11 joint count
Standard Deviation 4.619
|
|
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
|
-4.96 joint count
Standard Deviation 7.750
|
|
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 4.950
|
-4.85 joint count
Standard Deviation 4.961
|
|
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
|
-6.42 joint count
Standard Deviation 6.652
|
|
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
|
-5.85 joint count
Standard Deviation 5.540
|
|
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
|
-6.83 joint count
Standard Deviation 7.755
|
|
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
|
-6.54 joint count
Standard Deviation 6.324
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6 and 8Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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
|
71.75 units on a scale
Standard Deviation 16.183
|
|
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
|
69.00 units on a scale
Standard Deviation 16.115
|
|
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
|
74.07 units on a scale
Standard Deviation 12.844
|
|
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
|
-2.86 units on a scale
Standard Deviation 14.847
|
|
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
|
-1.93 units on a scale
Standard Deviation 9.149
|
|
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
|
-4.96 units on a scale
Standard Deviation 8.126
|
|
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
|
-6.04 units on a scale
Standard Deviation 12.669
|
|
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
|
-2.81 units on a scale
Standard Deviation 9.931
|
|
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
|
-10.63 units on a scale
Standard Deviation 12.500
|
|
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
|
-10.23 units on a scale
Standard Deviation 25.513
|
|
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
|
-12.12 units on a scale
Standard Deviation 19.574
|
|
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
|
-17.96 units on a scale
Standard Deviation 18.877
|
|
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
|
-12.35 units on a scale
Standard Deviation 27.425
|
|
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
|
-11.65 units on a scale
Standard Deviation 21.630
|
|
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
|
-19.50 units on a scale
Standard Deviation 22.963
|
|
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
|
-18.58 units on a scale
Standard Deviation 34.152
|
|
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
|
-15.88 units on a scale
Standard Deviation 30.135
|
|
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
|
-23.75 units on a scale
Standard Deviation 25.902
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6 and 8Population: 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.
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.
Outcome measures
| Measure |
PF-06651600
n=42 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
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
|
1.69 units on a scale
Standard Deviation 0.550
|
|
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
|
-0.04 units on a scale
Standard Deviation 0.316
|
|
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 0.430
|
-0.15 units on a scale
Standard Deviation 0.347
|
|
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
|
-0.19 units on a scale
Standard Deviation 0.534
|
|
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
|
-0.23 units on a scale
Standard Deviation 0.609
|
|
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
|
-0.32 units on a scale
Standard Deviation 0.671
|
Adverse Events
PF-06651600
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06651600
n=42 participants at risk
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.
|
Placebo
n=28 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
3/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Gastrointestinal disorders
Glossitis
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
General disorders
Fatigue
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
General disorders
Oedema peripheral
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Infections and infestations
Fungal skin infection
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Infections and infestations
Influenza
|
7.1%
3/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Infections and infestations
Oral herpes
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/42 • Baseline up to Week 12
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.
|
3.6%
1/28 • Baseline up to Week 12
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.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/42 • Baseline up to Week 12
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.
|
3.6%
1/28 • Baseline up to Week 12
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.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/42 • Baseline up to Week 12
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.
|
3.6%
1/28 • Baseline up to Week 12
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Investigations
Cytomegalovirus test positive
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/42 • Baseline up to Week 12
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.
|
3.6%
1/28 • Baseline up to Week 12
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.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/42 • Baseline up to Week 12
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.
|
10.7%
3/28 • Baseline up to Week 12
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.
|
|
Psychiatric disorders
Suicidal ideation
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
2/42 • Baseline up to Week 12
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.
|
3.6%
1/28 • Baseline up to Week 12
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.4%
1/42 • Baseline up to Week 12
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.
|
0.00%
0/28 • Baseline up to Week 12
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER