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A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01359150
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : March 29, 2013
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: CP-690,550
Drug: placebo
Enrollment 223
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice. Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Period Title: Overall Study
Started 112 111
Completed 105 106
Not Completed 7 5
Reason Not Completed
Lack of Efficacy             1             1
Withdrawal by Subject             1             1
Adverse Event             4             3
Other             1             0
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine Total
Hide Arm/Group Description CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice. Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice. Total of all reporting groups
Overall Number of Baseline Participants 112 111 223
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 111 participants 223 participants
52.7  (10.4) 52.2  (11.1) 52.4  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 111 participants 223 participants
Female
81
  72.3%
90
  81.1%
171
  76.7%
Male
31
  27.7%
21
  18.9%
52
  23.3%
Number of Participants With Background (BG) Methotrexate (MTX) use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants 111 participants 223 participants
With Background MTX use 62 62 124
Without Background MTX use 50 49 99
1.Primary Outcome
Title Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)
Hide Description Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.
Time Frame Day 64 (End of Study [EOS])
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Regardless MTX use (n=102,98)
45.1
(35.224 to 55.264)
68.4
(58.196 to 77.394)
With BG MTX use (n=57,55)
31.6
(19.905 to 45.243)
61.8
(47.726 to 74.591)
Without BG MTX use (n=45,43)
62.2
(46.541 to 76.232)
76.7
(61.369 to 88.245)
2.Primary Outcome
Title Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)
Hide Description Satisfactory humoral response to the influenza vaccine was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.
Time Frame Day 64 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Regardless MTX use (n=102,98)
56.9
(46.682 to 66.634)
62.2
(51.885 to 71.844)
With BG MTX use (n=57,55)
50.9
(37.29 to 64.37)
58.2
(44.106 to 71.345)
Without BG MTX use (n=45,43)
64.4
(48.78 to 78.132)
67.4
(51.456 to 80.924)
3.Secondary Outcome
Title Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens
Hide Description Response to the pneumococcal vaccine (seroconversion) was defined as >= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.
Time Frame Day 64 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Regardless MTX use, 1 (n=102,98)
59.8
(49.63 to 69.393)
69.4
(59.265 to 78.302)
Regardless MTX use, 14 (n=102,98)
52
(41.844 to 61.961)
61.2
(50.849 to 70.903)
Regardless MTX use, 18C (n=102,98)
59.8
(49.63 to 69.393)
70.4
(60.338 to 79.205)
Regardless MTX use, 19A (n=102,98)
32.4
(23.424 to 42.337)
46.9
(36.778 to 57.289)
Regardless MTX use, 19F (n=102,98)
35.3
(26.086 to 45.38)
56.1
(45.732 to 66.133)
Regardless MTX use, 23F (n=102,98)
40.2
(30.607 to 50.37)
58.2
(47.766 to 68.054)
Regardless MTX use, 3 (n=102,98)
38.2
(28.787 to 48.386)
54.1
(43.714 to 64.196)
Regardless MTX use, 4 (n=102,98)
58.8
(48.644 to 68.477)
65.3
(55.02 to 74.64)
Regardless MTX use, 5 (n=102,98)
28.4
(19.938 to 38.218)
38.8
(29.097 to 49.151)
Regardless MTX use, 6B (n=102,98)
36.3
(26.982 to 46.386)
54.1
(43.714 to 64.196)
Regardless MTX use, 7F (n=102,98)
58.8
(48.644 to 68.477)
65.3
(55.02 to 74.64)
Regardless MTX use, 9V (n=102,98)
45.1
(35.224 to 55.264)
58.2
(47.766 to 68.054)
With BG MTX use, 1 (n=57,55)
57.9
(44.084 to 70.857)
61.8
(47.726 to 74.591)
With BG MTX use, 14 (n=57,55)
47.4
(33.985 to 61.035)
56.4
(42.322 to 69.696)
With BG MTX use, 18C (n=57,55)
49.1
(35.63 to 62.71)
58.2
(44.106 to 71.345)
With BG MTX use, 19A (n=57,55)
19.3
(10.047 to 31.911)
40
(27.023 to 54.093)
With BG MTX use, 19F (n=57,55)
28.1
(16.973 to 41.543)
49.1
(35.354 to 62.929)
With BG MTX use, 23F (n=57,55)
24.6
(14.127 to 37.761)
49.1
(35.354 to 62.929)
With BG MTX use, 3 (n=57,55)
24.6
(14.127 to 37.761)
49.1
(35.354 to 62.929)
With BG MTX use, 4 (n=57,55)
52.6
(38.965 to 66.015)
56.4
(42.322 to 69.696)
With BG MTX use, 5 (n=57,55)
28.1
(16.973 to 41.543)
29.1
(17.63 to 42.898)
With BG MTX use, 6B (n=57,55)
29.8
(18.429 to 43.403)
47.3
(33.653 to 61.196)
With BG MTX use, 7F (n=57,55)
49.1
(35.63 to 62.71)
56.4
(42.322 to 69.696)
With BG MTX use, 9V (n=57,55)
33.3
(21.401 to 47.065)
49.1
(35.354 to 62.929)
Without BG MTX use, 1 (n=45,43)
62.2
(46.541 to 76.232)
79.1
(63.958 to 89.956)
Without BG MTX use, 14 (n=45,43)
57.8
(42.15 to 72.343)
67.4
(51.456 to 80.924)
Without BG MTX use, 18C (n=45,43)
73.3
(58.055 to 85.396)
86
(72.068 to 94.702)
Without BG MTX use, 19A (n=45,43)
48.9
(33.703 to 64.226)
55.8
(39.875 to 70.922)
Without BG MTX use, 19F (n=45,43)
44.4
(29.644 to 60.003)
65.1
(49.073 to 78.992)
Without BG MTX use, 23F (n=45,43)
60
(44.331 to 74.302)
69.8
(53.875 to 82.818)
Without BG MTX use, 3 (n=45,43)
55.6
(39.997 to 70.356)
60.5
(44.41 to 75.023)
Without BG MTX use, 4 (n=45,43)
66.7
(51.05 to 79.999)
76.7
(61.369 to 88.245)
Without BG MTX use, 5 (n=45,43)
28.9
(16.366 to 44.315)
51.2
(35.465 to 66.695)
Without BG MTX use, 6B (n=45,43)
44.4
(29.644 to 60.003)
62.8
(46.725 to 77.025)
Without BG MTX use, 7F (n=45,43)
71.1
(55.685 to 83.634)
76.7
(61.369 to 88.245)
Without BG MTX use, 9V (n=45,43)
60
(44.331 to 74.302)
69.8
(53.875 to 82.818)
4.Secondary Outcome
Title Percentage of Participants Who Responded to Each of the 3 Influenza Antigens
Hide Description Response to the influenza vaccine (seroconversion) was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.
Time Frame Day 64 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Regardless MTX use, B (n=102,98)
38.2
(28.787 to 48.386)
52
(41.712 to 62.243)
Regardless MTX use, H1N1 (n=102,98)
60.8
(50.62 to 70.305)
63.3
(52.925 to 72.781)
Regardless MTX use, H3N2 (n=102,98)
60.8
(50.62 to 70.305)
69.4
(59.265 to 78.302)
With BG MTX use, B (n=57,55)
35.1
(22.915 to 48.869)
41.8
(28.655 to 55.894)
With BG MTX use, H1N1 (n=57,55)
52.6
(38.965 to 66.015)
58.2
(44.106 to 71.345)
With BG MTX use, H3N2 (n=57,55)
57.9
(44.084 to 70.857)
65.5
(51.419 to 77.763)
Without BG MTX use, B (n=45,43)
42.2
(27.657 to 57.85)
65.1
(49.073 to 78.992)
Without BG MTX use, H1N1 (n=45,43)
71.1
(55.685 to 83.634)
69.8
(53.875 to 82.818)
Without BG MTX use, H3N2 (n=45,43)
64.4
(48.78 to 78.132)
74.4
(58.828 to 86.481)
5.Secondary Outcome
Title Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine
Hide Description Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of >= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.
Time Frame Day 64 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Regardless MTX use (n=102,98)
76.5
(67.043 to 84.305)
91.8
(84.547 to 96.41)
With BG MTX use (n=57,55)
64.9
(51.131 to 77.085)
92.7
(82.413 to 97.983)
Without BG MTX use (n=45,43)
91.1
(78.779 to 97.525)
90.7
(77.865 to 97.407)
6.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)
Hide Description Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.
Time Frame Day 64 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Regardless MTX use, 1 (n=89,92)
4.75
(3.61 to 6.24)
6.83
(4.94 to 9.46)
Regardless MTX use, 14 (n=101,96)
2.68
(2.19 to 3.28)
3.90
(3.05 to 4.99)
Regardless MTX use, 18C (n=101,98)
3.10
(2.52 to 3.81)
4.82
(3.76 to 6.18)
Regardless MTX use, 19A (n=102,98)
1.80
(1.56 to 2.08)
2.34
(1.99 to 2.75)
Regardless MTX use, 19F (n=102,95)
2.04
(1.71 to 2.42)
2.89
(2.40 to 3.49)
Regardless MTX use, 23F (n=102,98)
2.00
(1.64 to 2.44)
2.81
(2.34 to 3.36)
Regardless MTX use, 3 (n=101,94)
2.11
(1.76 to 2.54)
2.79
(2.31 to 3.38)
Regardless MTX use, 4 (n=96,89)
3.10
(2.49 to 3.86)
5.13
(3.94 to 6.67)
Regardless MTX use, 5 (n=101,98)
1.72
(1.50 to 1.97)
2.27
(1.91 to 2.70)
Regardless MTX use, 6B (n=102,98)
1.90
(1.61 to 2.24)
2.56
(2.12 to 3.10)
Regardless MTX use, 7F (n=102,97)
3.19
(2.59 to 3.93)
4.06
(3.27 to 5.04)
Regardless MTX use, 9V (n=102,98)
2.27
(1.85 to 2.55)
3.16
(2.59 to 3.86)
With BG MTX use, 1 (n=49,53)
3.92
(2.77 to 5.54)
4.51
(3.00 to 6.77)
With BG MTX use, 14 (n=56,54)
2.37
(1.84 to 3.04)
2.85
(2.19 to 3.72)
With BG MTX use, 18C (n=57,55)
2.64
(2.05 to 3.41)
3.23
(2.45 to 4.26)
With BG MTX use, 19A (n=57,55)
1.51
(1.30 to 1.74)
2.08
(1.67 to 2.59)
With BG MTX use, 19F (n=57,53)
1.92
(1.51 to 2.44)
2.29
(1.88 to 2.79)
With BG MTX use, 23F (n=57,55)
1.66
(1.32 to 2.07)
2.34
(1.88 to 2.91)
With BG MTX use, 3 (n=56,54)
1.78
(1.39 to 2.27)
2.43
(1.90 to 3.12)
With BG MTX use, 4 (n=53,50)
2.92
(2.22 to 3.85)
3.27
(2.51 to 4.25)
With BG MTX use, 5 (n=57,55)
1.62
(1.35 to 1.95)
1.99
(1.59 to 2.50)
With BG MTX use, 6B (n=57,55)
1.60
(1.37 to 1.88)
2.24
(1.79 to 2.81)
With BG MTX use, 7F (n=57,55)
2.38
(1.89 to 2.98)
3.46
(2.57 to 4.64)
With BG MTX use, 9V (n=57,55)
1.87
(1.53 to 2.29)
2.72
(2.08 to 3.54)
Without BG MTX use, 1 (n=40,39)
6.01
(3.85 to 9.37)
12.04
(7.34 to 19.74)
Without BG MTX use, 14 (n=45,42)
3.14
(2.25 to 4.37)
5.85
(3.81 to 8.99)
Without BG MTX use, 18C (n=44,43)
3.80
(2.70 to 5.35)
8.05
(5.37 to 12.08)
Without BG MTX use, 19A (n=45,43)
2.27
(1.75 to 2.94)
2.72
(2.13 to 3.47)
Without BG MTX use, 19F (n=45,42)
2.19
(1.68 to 2.85)
3.88
(2.78 to 5.43)
Without BG MTX use, 23F (n=45,43)
2.54
(1.81 to 3.58)
3.55
(2.63 to 4.78)
Without BG MTX use, 3 (n=45,40)
2.61
(1.98 to 3.44)
3.37
(2.49 to 4.55)
Without BG MTX use, 4 (n=43,39)
3.32
(2.31 to 4.79)
9.15
(5.85 to 14.29)
Without BG MTX use, 5 (n=44,43)
1.86
(1.50 to 2.29)
2.68
(2.04 to 3.52)
Without BG MTX use, 6B (n=45,43)
2.36
(1.73 to 3.21)
3.04
(2.19 to 4.21)
Without BG MTX use, 7F (n=45,42)
4.62
(3.23 to 6.60)
5.02
(3.65 to 6.90)
Without BG MTX use, 9V (n=45,43)
2.63
(2.03 to 3.41)
3.83
(2.82 to 5.19)
7.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)
Hide Description GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.
Time Frame Day 64 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Regardless MTX use, B (n=102,98)
2.95
(2.32 to 3.75)
3.90
(3.06 to 4.97)
Regardless MTX use, H1N1 (n=102,98)
6.04
(4.59 to 7.95)
9.50
(6.76 to 13.35)
Regardless MTX use, H3N2 (n=102,98)
7.11
(5.18 to 9.75)
9.06
(6.61 to 12.44)
With BG MTX use, B (n=57,55)
2.84
(2.02 to 3.98)
3.11
(2.27 to 4.26)
With BG MTX use, H1N1 (n=57,55)
4.90
(3.43 to 7.00)
7.54
(4.80 to 11.85)
With BG MTX use, H3N2 (n=57,55)
5.69
(3.88 to 8.34)
6.04
(4.18 to 8.73)
Without BG MTX use, B (n=45,43)
3.11
(2.20 to 4.40)
5.20
(3.57 to 7.57)
Without BG MTX use, H1N1 (n=45,43)
7.88
(5.13 to 12.10)
12.76
(7.56 to 21.53)
Without BG MTX use, H3N2 (n=45,43)
9.43
(5.52 to 16.09)
15.25
(9.06 to 25.66)
8.Secondary Outcome
Title Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody
Hide Description Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
Time Frame Day 64 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Geometric Mean (95% Confidence Interval)
Unit of Measure: microgram/milliliter (mcg/mL)
1
1.81
(1.32 to 2.48)
3.27
(2.34 to 4.58)
14
5.24
(3.85 to 7.12)
6.40
(4.63 to 8.84)
18C
2.53
(1.95 to 3.29)
4.60
(3.48 to 6.09)
19A
5.21
(4.15 to 6.54)
8.57
(6.86 to 10.70)
19F
2.59
(1.93 to 3.47)
3.09
(2.28 to 4.19)
23F
2.41
(1.86 to 3.11)
3.55
(2.78 to 4.55)
3
0.66
(0.52 to 0.86)
1.11
(0.86 to 1.43)
4
0.72
(0.54 to 0.97)
1.07
(0.77 to 1.48)
5
4.05
(3.23 to 5.09)
5.79
(4.60 to 7.30)
6B
2.99
(2.34 to 3.83)
4.75
(3.71 to 6.07)
7F
3.28
(2.42 to 4.45)
4.37
(3.36 to 5.67)
9V
2.61
(2.11 to 3.23)
4.06
(3.29 to 5.01)
9.Secondary Outcome
Title Geometric Mean Titer (GMT) of Anti-Influenza Antibody
Hide Description Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
Time Frame Day 64 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description:
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Overall Number of Participants Analyzed 102 98
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
B
33.39
(25.61 to 43.54)
50.74
(39.82 to 64.64)
H1N1
86.40
(64.35 to 116.0)
221.5
(161.4 to 304.0)
H3N2
132.3
(97.65 to 179.1)
244.0
(184.6 to 322.5)
Time Frame [Not Specified]
Adverse Event Reporting 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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Hide Arm/Group Description CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice. Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
All-Cause Mortality
CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   4/112 (3.57%)   1/111 (0.90%) 
Cardiac disorders     
Atrial fibrillation * 1  1/112 (0.89%)  0/111 (0.00%) 
General disorders     
Chest pain * 1  1/112 (0.89%)  0/111 (0.00%) 
Infections and infestations     
Cellulitis * 1  0/112 (0.00%)  1/111 (0.90%) 
Pneumonia * 1  1/112 (0.89%)  0/111 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/112 (0.89%)  0/111 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
CP-690,550 + Influenza and Pneumococcal Vaccine Placebo + Influenza and Pneumococcal Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   17/112 (15.18%)   17/111 (15.32%) 
Gastrointestinal disorders     
Diarrhoea * 1  1/112 (0.89%)  4/111 (3.60%) 
Infections and infestations     
Upper respiratory tract infection * 1  6/112 (5.36%)  8/111 (7.21%) 
Urinary tract infection * 1  3/112 (2.68%)  4/111 (3.60%) 
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis * 1  0/112 (0.00%)  3/111 (2.70%) 
Nervous system disorders     
Dizziness * 1  3/112 (2.68%)  0/111 (0.00%) 
Headache * 1  5/112 (4.46%)  1/111 (0.90%) 
Respiratory, thoracic and mediastinal disorders     
Sinus congestion * 1  3/112 (2.68%)  0/111 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01359150     History of Changes
Other Study ID Numbers: A3921129
First Submitted: May 11, 2011
First Posted: May 24, 2011
Results First Submitted: January 7, 2013
Results First Posted: March 29, 2013
Last Update Posted: March 29, 2013