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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Immune Response Following Administration of Zoster Vaccine to Subjects With Rheumatoid Arthritis Receiving Tofacitinib (CP-690,550) or Placebo With Background Methotrexate Treatment

    Summary
    EudraCT number
    		 2014-000706-34
    Trial protocol
    		 GB  
    Global end of trial date
    06 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2016
    First version publication date
    07 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3921237
    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, 10017
    Public contact
    Pfizer, Inc., Pfizer ClinicalTrials.gov Call Center, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, 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
    13 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the effect of tofacitinib on varicella zoster virus (VZV)-specific immunoglobulin reponses 6 weeks after zoster vaccination in patients with rheumatoid arthritis (RA) on background methotrexate (MTX).
    Protection of trial subjects
    A Data Monitoring Committee (DMC) was responsible for ongoing monitoring of patient safety according to the Charter. Recommendations made by the DMC to alter the conduct of the study were forwarded to the Sponsor for final decision.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jun 2014
    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
    United States: 112
    Worldwide total number of subjects
    112
    EEA total number of subjects
    0
    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)
    77
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult subjects ≥50 years with active RA, characterized by ≥4 tender/painful joints and ≥4 swollen joints at screening or baseline before vaccination, and characterized by a screening CRP˃3mg/L or Clinical Disease Activity Index score˃10 at screening or baseline before vaccination, and had ≥4 month treatment with MTX 15-25mg/week before screening.

    Pre-assignment
    Screening details
    		 The zoster vaccine was administered at least 2 weeks (14 to 21 days) prior to initiation of CP-690,550 (tofacitinib) or placebo in rheumatoid arthritis (RA) patients on background methotrexate therapy.

    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
    		 Placebo Twice a Day
    Arm description
    		 Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.
    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
    orally twice a day

    Arm title
    		 Tofacitinib 5 mg Twice a Day
    Arm description
    		 Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received tofacitinib 5 mg tablets twice a day orally for up to 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    tofacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg orally twice a day

    Number of subjects in period 1
    		Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Started
    57
    55
    Completed
    46
    50
    Not completed
    11
    5
         Adverse event, non-fatal
    9
    4
         Lack of efficacy
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Twice a Day
    Reporting group description
    		 Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.

    Reporting group title
    Tofacitinib 5 mg Twice a Day
    Reporting group description
    		 Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received tofacitinib 5 mg tablets twice a day orally for up to 12 weeks.

    Reporting group values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day Total
    Number of subjects
    		 57 55 112
    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)
    		 39 38 77
        From 65-84 years
    		 18 17 35
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 62 ± 8.7 61.7 ± 6.2 -
    Gender, Male/Female
    Units: participants
        FEMALE
    		 38 42 80
        MALE
    		 19 13 32

    End points

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    End points reporting groups
    Reporting group title
    Placebo Twice a Day
    Reporting group description
    		 Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received placebo matched tofacitinib tablets twice a day orally for up to 12 weeks.

    Reporting group title
    Tofacitinib 5 mg Twice a Day
    Reporting group description
    		 Following administration of zoster vaccine, participants with Rheumatoid Arthritis (RA) on background methotrexate received tofacitinib 5 mg tablets twice a day orally for up to 12 weeks.

    Primary: Fold Rise From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4

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    End point title
    		 Fold Rise From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
    End point description
    VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA). Baseline units are measured in units of glycoprotein ELISA units per milliliter (gp ELISA units/mL).
    End point type
    Primary
    End point timeframe
    Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)
    End point values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Number of subjects analysed
    53
    54
    Units: fold rise
    number (not applicable)
        Baseline (gp ELISA units/mL)
    182.338
    200.952
        Fold Rise at Week 4
    1.736
    2.105
    Statistical analysis title
    		 Geometric Mean Fold Rise (GMFR) at Week 4
    Statistical analysis description
    Geometric Mean Fold Rise (GMFR) for Tofacitinib versus Placebo (Week 4)
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMFR
    Point estimate
    1.213
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 1.033
         upper limit
    		 1.424

    Secondary: Fold Rise From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12

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    End point title
    		 Fold Rise From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12
    End point description
    The evaluable immunogenicity analysis population included randomized patients who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
    End point values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Number of subjects analysed
    53
    54
    Units: fold rise
    number (not applicable)
        Fold Rise at Day 1 (n=53,54)
    1.947
    2.005
        Fold Rise at Week 12 (n=44,48)
    1.496
    1.636
    Statistical analysis title
    		 GMFR at Week 12
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMFR
    Point estimate
    1.093
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.924
         upper limit
    		 1.294
    Statistical analysis title
    		 GMFR at Day 1
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMFR
    Point estimate
    1.03
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.877
         upper limit
    		 1.209

    Secondary: Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12

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    End point title
    		 Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12
    End point description
    The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values.
    End point type
    Secondary
    End point timeframe
    Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
    End point values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Number of subjects analysed
    53
    54
    Units: gpELISA units/mL
    geometric mean (confidence interval 80%)
        Day -14
    182.338 (151.281 to 219.771)
    200.952 (166.045 to 243.198)
        Day 1 (n=53,54)
    361.603 (300.012 to 435.838)
    384.219 (317.477 to 464.993)
        Week 4 (n=53,54)
    322.486 (267.557 to 388.69)
    403.422 (333.343 to 488.232)
        Week 12 (n=44,48)
    278.599 (229.984 to 337.489)
    312.328 (257.319 to 379.096)
    Statistical analysis title
    		 Ratio of GMT at Day 1
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMT
    Point estimate
    1.063
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.821
         upper limit
    		 1.375
    Statistical analysis title
    		 Ratio of GMT at Week 4
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMT
    Point estimate
    1.251
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.967
         upper limit
    		 1.618
    Statistical analysis title
    		 Ratio of GMT at Week 12
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMT
    Point estimate
    1.121
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.862
         upper limit
    		 1.459

    Secondary: Percentage of Patients With >=1.5 Fold Rise in VZV-Specific IgG Levels Day 1, Week 4 and Week 12

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    End point title
    		 Percentage of Patients With >=1.5 Fold Rise in VZV-Specific IgG Levels Day 1, Week 4 and Week 12
    End point description
    VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (>=) 1.5 was defined as a responder.
    End point type
    Secondary
    End point timeframe
    Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
    End point values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Number of subjects analysed
    53
    54
    Units: percentage of patients
    number (not applicable)
        Day 1 (n=53,54)
    47.17
    55.56
        Week 4 (n=53,54)
    43.4
    57.41
        Week 12 (n=44,48)
    43.18
    45.83
    Statistical analysis title
    		 Tofacitinib versus Placebo (Day 1)
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 80% CI based on Chan and Zhang method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.39
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -4.05
         upper limit
    		 20.56
    Statistical analysis title
    		 Tofacitinib versus Placebo (Week 4)
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 80% CI based on Chan and Zhang method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14.01
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 1.57
         upper limit
    		 26.03
    Statistical analysis title
    		 Tofacitinib versus Placebo (Week 12)
    Comparison groups
    Placebo Twice a Day v Tofacitinib 5 mg Twice a Day
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 80% CI based on Chan and Zhang method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.65
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -10.66
         upper limit
    		 15.83

    Other pre-specified: Number of Patients With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

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    End point title
    		 Number of Patients With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a patient who received study drug. An 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 16 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Number of subjects analysed
    57
    55
    Units: patients
        AEs
    21
    16
        SAEs
    0
    3
    No statistical analyses for this end point

    Other pre-specified: Number of Patients With Zoster Vaccine-Related AEs by System Organ Class

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    End point title
    		 Number of Patients With Zoster Vaccine-Related AEs by System Organ Class
    End point description
    Zoster vaccine-related AEs included General Disorders and Administration Site Conditions (injection site erythema, pain, pruritis, rash, swelling; vaccination site erythema, pruritus, rash), Infections and Infestations (disseminated herpes zoster), and Musculoskeletal and Connective Tissue Disorders (myalgia). All zoster vaccine-related AEs were mild, except for the herpes zoster AE classified under Infections and Infestations, which was moderate in severity.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Number of subjects analysed
    57
    55
    Units: patients
        General and Administration Site Conditions
    2
    4
        Infections and Infestations
    0
    1
        Musculoskeletal and Connective Tissue Disorders
    0
    1
    No statistical analyses for this end point

    Other pre-specified: Number of Patients With Clinical Herpes Zoster Events by Severity

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    End point title
    		 Number of Patients With Clinical Herpes Zoster Events by Severity
    End point description
    Clinical herpes is manifested as mild, moderate, or severe disseminated herpes zoster.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Number of subjects analysed
    57
    55
    Units: patients
        Mild Herpes Zoster
    0
    0
        Moderate Herpes Zoster
    0
    1
        Severe Herpes Zoster
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Patients With Clinically Significant Abnormal Laboratory Parameters

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    End point title
    		 Number of Patients With Clinically Significant Abnormal Laboratory Parameters
    End point description
    Patients with the following abnormalities were discontinued from the study: 2 sequential absolute neutrophil counts (ANC) <1000/mm^3; 2 sequential hemoglobin values <8.0 g/dL or decreases of >30% from baseline value; 2 sequential absolute lymphocyte count <500/mm^3; 2 sequential platelet counts <75,000/mm^3; 2 sequential alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations >=3 times the upper limit of normal (X ULN) with a total bilirubin value >=2X ULN, elevated international normalized ratio (INR), or accompanied by signs/symptoms consistent with hepatic injury; 2 sequential ALT or AST elevations >=5X ULN regardless of total bilirubin or accompanying symptoms; confirmed increases in serum creatinine (SCr) >50% over the average of screening and baseline values; a confirmed positive urine pregnancy test or refusal to use appropriate contraception in a woman of childbearing potential.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Placebo Twice a Day Tofacitinib 5 mg Twice a Day
    Number of subjects analysed
    57
    55
    Units: patients
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 16
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one patient and as non-serious in another patient, or one patient may have experienced both a serious and non-serious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Tofacitinib 5 mg Twice a Day
    Reporting group description
    		 Following administration of zoster vaccine to RA patients receiving background methotrexate, patients received tofacitinib 5 mg twice a day orally for up to 12 weeks.

    Reporting group title
    Placebo Twice a Day
    Reporting group description
    		 Following administration of zoster vaccine to rheumatoid arthritis (RA) patients receiving background methotrexate, patients received tofacitinib-matched placebo tablets twice a day orally for up to 12 weeks.

    Serious adverse events
    		 Tofacitinib 5 mg Twice a Day Placebo Twice a Day
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster disseminated
    Additional description: adjudicated AE term "vaccine dissemination VZV"
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tofacitinib 5 mg Twice a Day Placebo Twice a Day
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 55 (10.91%)
    9 / 57 (15.79%)
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 57 (0.00%)
         occurrences all number
    3
    0
    Rheumatoid arthritis
         subjects affected / exposed
    3 / 55 (5.45%)
    9 / 57 (15.79%)
         occurrences all number
    3
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.

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