Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2A, Randomized, double blind, parallel group, placebo controlled, multi center study to assess the efficacy and safety profile of PF-06651600 in subjects with moderate to severe active rheumatoid arthritis with an inadequate response to methotrexate

    Summary
    EudraCT number
    		 2016-002862-30
    Trial protocol
    		 HU   CZ   SK   BG   DE   PL  
    Global end of trial date
    12 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2018
    First version publication date
    22 Nov 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B7981006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 110017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer ClinicalTrials.gov Call Center, 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of PF-06651600 at 8 weeks in subjects with moderate to severe active rheumatoid arthritis.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 15
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Georgia: 20
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Serbia: 14
    Country: Number of subjects enrolled
    Slovakia: 6
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    70
    EEA total number of subjects
    31
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    55
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Seventy subjects were enrolled at different centers in 8 countries between 2 February 2017 and 12 December 2017.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-06651600
    Arm description
    		 Subjects received 200 milligram (mg) of PF-06651600 tablet once daily for a period of 8 weeks. Subjects were followed up to 4 weeks after last dose of investigational drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 200 mg of PF-06651600 tablet once daily.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Subjects were followed up to 4 weeks after last dose of investigational drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matched to PF-06651600 200 mg tablet once daily.

    Number of subjects in period 1
    		PF-06651600 Placebo
    Started
    42
    28
    Completed
    37
    22
    Not completed
    5
    6
         Consent withdrawn by subject
    2
    6
         Adverse event, non-fatal
    3
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    PF-06651600
    Reporting group description
    		 Subjects received 200 milligram (mg) of PF-06651600 tablet once daily for a period of 8 weeks. Subjects were followed up to 4 weeks after last dose of investigational drug.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Subjects were followed up to 4 weeks after last dose of investigational drug.

    Reporting group values
    		 PF-06651600 Placebo Total
    Number of subjects
    		 42 28 70
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 33 22 55
        From 65-84 years
    		 9 6 15
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.4 ± 11.72 54.2 ± 11.78 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 33 24 57
        Male
    		 9 4 13
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 41 28 69
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 2 3
        Not Hispanic or Latino
    		 41 26 67
        Unknown or Not Reported
    		 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    PF-06651600
    Reporting group description
    		 Subjects received 200 milligram (mg) of PF-06651600 tablet once daily for a period of 8 weeks. Subjects were followed up to 4 weeks after last dose of investigational drug.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Subjects were followed up to 4 weeks after last dose of investigational drug.

    Primary: Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8

    		 Close Top of page
    End point title
    		 Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
    End point description
    The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, subject global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analog scale (VAS) 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. Intent to treat (ITT) analysis set included all subjects who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).Here, n=number of subjects evaluable at specified time points only.
    End point type
    Primary
    End point timeframe
    Baseline, Week 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline| (n =42, 28)
    45.15 ± 13.164
    44.85 ± 13.976
        Change at Week 8| (n =39, 24)
    -26.11 ± 14.834
    -17.38 ± 18.176
    Statistical analysis title
    		 PF-06651600 vs Placebo
    Comparison groups
    PF-06651600 v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -9.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.75
         upper limit
    		 -3.79

    Secondary: Number of Subjects With Vital Signs Abnormalities

    		 Close Top of page
    End point title
    		 Number of Subjects With Vital Signs Abnormalities
    End point description
    Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one subject had abnormality, were reported in this endpoint. Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: subjects
        Sitting DBP >=20 mmHg increase from baseline|
    3
    0
        Sitting DBP >=20 mmHg decrease from baseline|
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Abnormalities

    		 Close Top of page
    End point title
    		 Number of Subjects With Laboratory Abnormalities
    End point description
    Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholestrol:<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.Safety set.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: subjects
    42
    28
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a subject 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. Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: subjects
        AEs|
    20
    5
        SAEs|
    0
    0
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6
    End point description
    The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity. ITT analysis set included all subjects 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 subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, and 6
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change at Week 1| (n =40, 28)
    -4.59 ± 9.409
    -4.52 ± 7.025
        Change at Week 2| (n =42, 27)
    -12.82 ± 10.969
    -8.05 ± 9.402
        Change at Week 4| (n =41, 26)
    -17.79 ± 12.804
    -12.55 ± 13.462
        Change at Week 6| (n =40, 26)
    -22.79 ± 14.007
    -15.62 ± 14.231
    No statistical analyses for this end point

    Secondary: Remission Rate Based on Simple Disease Activity Index Score

    		 Close Top of page
    End point title
    		 Remission Rate Based on Simple Disease Activity Index Score
    End point description
    Remission rate was defined as percentage of subjects 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 0-10 cm VAS; higher scores=greater affection due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity. ITT analysis set included all subjects who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
    End point type
    Secondary
    End point timeframe
    Week 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: percentage of subjects
    number (not applicable)
        Week 4|
    4.8
    0.0
        Week 6|
    4.8
    0.0
        Week 8|
    7.1
    0.0
    No statistical analyses for this end point

    Secondary: Remission Rate Based on Disease Activity score (DAS28-4[ESR])

    		 Close Top of page
    End point title
    		 Remission Rate Based on Disease Activity score (DAS28-4[ESR])
    End point description
    Remission rate was defined as the percentage of subjects with disease remission. DAS28 was calculated from the number of SJC and TJC using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and subject's global assessment (PGA) of disease activity (subject rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Subjects who had DAS28 <=3.2 were considered in remission or LDA state. ITT analysis set included all subjects who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
    End point type
    Secondary
    End point timeframe
    Week 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: percentage of subjects
    number (not applicable)
        Week 4: DAS28-4(ESR)|
    4.8
    0.0
        Week 6: DAS28-4(ESR)|
    4.8
    0.0
        Week 8: DAS28-4(ESR)|
    7.1
    0.0
    No statistical analyses for this end point

    Secondary: Remission Rate Based on Disease Activity score (DAS28-3 [ESR])

    		 Close Top of page
    End point title
    		 Remission Rate Based on Disease Activity score (DAS28-3 [ESR])
    End point description
    Remission rate was defined as the percentage of subjects with disease remission. DAS28 is measure of disease activity in subjects with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (millimeters per hour [mm/hour]). 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. ITT analysis set included all subjects who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
    End point type
    Secondary
    End point timeframe
    Week 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: percentage of subjects
    number (not applicable)
        Week 4
    4.8
    0.0
        Week 6
    2.4
    0.0
        Week 8
    7.1
    0.0
    No statistical analyses for this end point

    Secondary: Remission Rate Based on Disease Activity score (DAS28-4 [CRP])

    		 Close Top of page
    End point title
    		 Remission Rate Based on Disease Activity score (DAS28-4 [CRP])
    End point description
    Remission rate was defined as the percentage of subjects with disease remission. DAS28 is measure of disease activity in subjects with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (subject 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. ITT analysis set included all subjects who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
    End point type
    Secondary
    End point timeframe
    Week 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: percentage of subjects
    number (not applicable)
        Week 4
    9.5
    0.0
        Week 6
    9.5
    3.6
        Week 8
    9.5
    0.0
    No statistical analyses for this end point

    Secondary: Remission Rate Based on Disease Activity score (DAS28-3 [CRP])

    		 Close Top of page
    End point title
    		 Remission Rate Based on Disease Activity score (DAS28-3 [CRP])
    End point description
    Remission rate was defined as the percentage of subjects with disease remission. DAS28 is measure of disease activity in subjects 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. ITT analysis set included all subjects who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).
    End point type
    Secondary
    End point timeframe
    Week 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: percentage of subjects
    number (not applicable)
        Week 4
    9.5
    0.0
        Week 6
    7.1
    3.6
        Week 8
    9.5
    0.0
    No statistical analyses for this end point

    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

    		 Close Top of page
    End point title
    		 Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8
    End point description
    DAS28 is measure of disease activity in subjects. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hour). 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. ITT analysis set included all subjects 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 subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline| (n =42, 28)
    6.49 ± 0.762
    6.37 ± 0.815
        Change at Week 1| (n =40, 28)
    -0.19 ± 0.604
    -0.26 ± 0.434
        Change at Week 2| (n =42, 27)
    -0.67 ± 0.602
    -0.46 ± 0.531
        Change at Week 4| (n =41, 26)
    -1.16 ± 1.125
    -0.78 ± 0.905
        Change at Week 6| (n =40, 25)
    -1.54 ± 1.123
    -1.07 ± 0.989
        Change at Week 8| (n =39, 24)
    -1.85 ± 1.161
    -1.07 ± 1.214
    No statistical analyses for this end point

    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

    		 Close Top of page
    End point title
    		 Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8
    End point description
    DAS28 is measure of disease activity in subjects. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (subject 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. ITT analysis set included all subjects 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 subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline| (n =42, 28)
    6.82 ± 0.815
    6.72 ± 0.880
        Change at Week 1| (n =40, 28)
    -0.27 ± 0.553
    -0.27 ± 0.477
        Change at Week 2| (n =42, 27)
    -0.83 ± 0.695
    -0.47 ± 0.551
        Change at Week 4| (n =41, 26)
    -1.36 ± 1.173
    -0.89 ± 0.951
        Change at Week 6| (n =40, 25)
    -1.81 ± 1.179
    -1.18 ± 1.050
        Change at Week 8| (n =39, 24)
    -2.14 ± 1.269
    -1.22 ± 1.448
    No statistical analyses for this end point

    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

    		 Close Top of page
    End point title
    		 Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8
    End point description
    DAS28 is measure of disease activity in subjects. 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. ITT analysis set included all subjects 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 subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline| (n =42, 28)
    5.76 ± 0.824
    5.61 ± 0.894
        Change at Week 1| (n =40, 28)
    -0.35 ± 0.741
    -0.20 ± 0.456
        Change at Week 2| (n =42, 27)
    -0.86 ± 0.782
    -0.47 ± 0.585
        Change at Week 4| (n =41, 26)
    -1.33 ± 1.219
    -0.72 ± 1.005
        Change at Week 6| (n =40, 26)
    -1.53 ± 1.286
    -1.01 ± 0.993
        Change at Week 8| (n =39, 24)
    -1.79 ± 1.265
    -1.03 ± 1.146
    No statistical analyses for this end point

    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

    		 Close Top of page
    End point title
    		 Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8
    End point description
    DAS28 is measure of disease activity in subjects. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (subject 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. ITT analysis set included all subjects 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 subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline| (n =42, 28)
    6.11 ± 0.850
    5.98 ± 0.926
        Change at Week 1| (n =40, 28)
    -0.41 ± 0.685
    -0.21 ± 0.473
        Change at Week 2| (n =42, 27)
    -0.99 ± 0.823
    -0.47 ± 0.574
        Change at Week 4| (n =41, 26)
    -1.49 ± 1.222
    -0.82 ± 1.013
        Change at Week 6| (n =40, 26)
    -1.78 ± 1.304
    -1.09 ± 1.057
        Change at Week 8| (n =39, 24)
    -2.06 ± 1.321
    -1.16 ± 1.367
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8
    End point description
    ITT analysis set included all subjects 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 subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: milligram per deciliter
    arithmetic mean (standard deviation)
        Baseline| (n =42, 28)
    2.00 ± 1.816
    1.68 ± 2.853
        Change at Week 1| (n =40, 28)
    -0.20 ± 2.672
    0.60 ± 2.263
        Change at Week 2| (n =42, 27)
    -0.62 ± 2.090
    -0.04 ± 0.966
        Change at Week 4| (n =41, 26)
    -0.93 ± 1.591
    0.00 ± 1.335
        Change at Week 6| (n =40, 26)
    -0.42 ± 2.376
    -0.23 ± 1.327
        Change at Week 8| (n =39, 24)
    -0.89 ± 2.142
    -0.04 ± 2.220
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Tender Joint count and Swollen Joint count at Week 1, 2, 4, 6 and 8

    		 Close Top of page
    End point title
    		 Change from Baseline in the Tender Joint count and Swollen Joint count at Week 1, 2, 4, 6 and 8
    End point description
    Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent. ITT analysis set included all subjects 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 subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: joints
    arithmetic mean (standard deviation)
        Baseline: Tender joint count| (n =42, 28)
    16.74 ± 6.765
    16.75 ± 6.681
        Baseline: Swollen joint count| (n =42, 28)
    12.95 ± 5.396
    12.11 ± 6.160
        Change at Week 1: Tender joint count| (n =41, 28)
    -1.54 ± 4.915
    -1.96 ± 2.701
        Change at Week 1: Swollen joint count| (n =41, 28)
    -1.49 ± 4.439
    -2.46 ± 3.501
        Change at Week 2: Tender joint count| (n =42, 27)
    -4.40 ± 5.522
    -2.56 ± 5.213
        Change at Week 2: Swollen joint count| (n =42, 27)
    -4.71 ± 4.430
    -4.11 ± 4.619
        Change at Week 4: Tender joint count| (n =41, 26)
    -6.76 ± 6.818
    -4.96 ± 7.750
        Change at Week 4: Swollen joint count| (n =41, 26)
    -5.95 ± 4.950
    -4.85 ± 4.961
        Change at Week 6: Tender joint count| (n =40, 26)
    -8.75 ± 7.132
    -6.42 ± 6.652
        Change at Week 6: Swollen joint count| (n =40, 26)
    -7.80 ± 5.743
    -5.85 ± 5.540
        Change at Week 8: Tender joint count| (n=39, 24)
    -10.21 ± 7.259
    -6.83 ± 7.755
        Change at Week 8: Swollen joint count| (n =39, 24)
    -8.59 ± 6.176
    -6.54 ± 6.324
    No statistical analyses for this end point

    Secondary: Change From Baseline in Subject’s Assessment of Arthritis Pain (PAAP), Subject’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8

    		 Close Top of page
    End point title
    		 Change From Baseline in Subject’s Assessment of Arthritis Pain (PAAP), Subject’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8
    End point description
    PAAP: Subjects 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: Subjects 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: Subjects were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the subject’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. ITT analysis set.n=number of subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: PAAP| (n =42, 28)
    66.64 ± 16.771
    71.75 ± 16.183
        Baseline: PGA| (n =42, 28)
    68.43 ± 15.639
    69.00 ± 16.115
        Baseline: PGAA| (n =42, 28)
    66.17 ± 14.228
    74.07 ± 12.844
        Change at Week 1: PAAP| (n =41, 28)
    -4.95 ± 11.388
    -2.86 ± 14.847
        Change at Week 1: PGA| (n =41, 28)
    -6.76 ± 11.128
    -1.93 ± 9.149
        Change at Week 1: PGAA| (n =41, 28)
    -6.83 ± 8.947
    -4.96 ± 8.126
        Change at Week 2: PAAP| (n =42, 27)
    -11.90 ± 18.061
    -6.04 ± 12.669
        Change at Week 2: PGA| (n =42, 27)
    -14.74 ± 15.963
    -2.81 ± 9.931
        Change at Week 2: PGAA| (n =42, 27)
    -16.07 ± 16.499
    -10.63 ± 12.500
        Change at Week 4: PAAP| (n =41, 26)
    -19.88 ± 16.695
    -10.23 ± 25.513
        Change at Week 4: PGA| (n =41, 26)
    -20.05 ± 13.746
    -12.12 ± 19.574
        Change at Week 4: PGAA| (n =41, 26)
    -21.49 ± 16.715
    -17.96 ± 18.877
        Change at Week 6: PAAP| (n =40, 26)
    -27.90 ± 20.061
    -12.35 ± 27.425
        Change at Week 6: PGA| (n =40, 26)
    -27.83 ± 18.936
    -11.65 ± 21.630
        Change at Week 6: PGAA| (n =40, 26)
    -30.45 ± 17.868
    -19.50 ± 22.963
        Change at Week 8: PAAP| (n =39, 24)
    -32.92 ± 25.051
    -18.58 ± 34.152
        Change at Week 8: PGA| (n =39, 24)
    -30.92 ± 21.279
    -15.88 ± 30.135
        Change at Week 8: PGAA| (n =39, 24)
    -33.28 ± 18.725
    -23.75 ± 25.902
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8
    End point description
    HAQ-DI assess degree of difficulty a subject 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. ITT analysis set included all subjects 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 subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 4, 6 and 8
    End point values
    		 PF-06651600 Placebo
    Number of subjects analysed
    42
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline| (n =42, 28)
    1.79 ± 0.577
    1.69 ± 0.550
        Change at Week 1| (n =41, 28)
    -0.13 ± 0.391
    -0.04 ± 0.316
        Change at Week 2| (n =42, 27)
    -0.26 ± 0.430
    -0.15 ± 0.347
        Change at Week 4| (n =41, 26)
    -0.39 ± 0.414
    -0.19 ± 0.534
        Change at Week 6| (n =40, 26)
    -0.46 ± 0.527
    -0.23 ± 0.609
        Change at Week 8| (n =39, 24)
    -0.53 ± 0.583
    -0.32 ± 0.671
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 12
    Adverse event reporting additional description
    Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v20.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to 200 mg of PF-06651600 tablets once daily for a period of 8 weeks. Subjects were followed up to 4 weeks after last dose of investigational drug.

    Reporting group title
    PF-06651600
    Reporting group description
    		 Subjects received 200 mg of PF-06651600 tablets once daily for a period of 8 weeks. Subjects were followed up to 4 weeks after last dose of investigational drug.

    Serious adverse events
    		 Placebo PF-06651600
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 42 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo PF-06651600
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 28 (17.86%)
    20 / 42 (47.62%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Cytomegalovirus test positive
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Glossitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 42 (4.76%)
         occurrences all number
    1
    2
    Rash maculo-papular
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Spinal pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Synovitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    3
    Oral herpes
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2016
    To monitor for potential changes in hearing between baseline (between Visit 1 and Visit 2 [inclusive]) and at the end of the study (between Visit 7 and Visit 9 [inclusive]).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 23:01:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA