| Primary | Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 64 (End of Study [EOS]) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
| | | Title | Denominators | Categories |
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| Regardless MTX use (n=102,98) | | | Title | Measurements |
|---|
| - OG00045.1(35.224 to 55.264)
- OG00168.4(58.196 to 77.394)
|
| | With BG MTX use (n=57,55) | | |
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| Primary | Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 64 (EOS) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
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| Secondary | Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 64 (EOS) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
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| Secondary | Percentage of Participants Who Responded to Each of the 3 Influenza Antigens | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 64 (EOS) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
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| Secondary | Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 64 (EOS) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
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| Secondary | Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | fold rise | | Day 64 (EOS) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
|
| Secondary | Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | fold rise | | Day 64 (EOS) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
|
| Secondary | Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | microgram/milliliter (mcg/mL) | | Day 64 (EOS) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
|
| Secondary | Geometric Mean Titer (GMT) of Anti-Influenza Antibody | 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 64 (EOS) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 + Influenza and Pneumococcal Vaccine | 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. | | OG001 | Placebo + Influenza and Pneumococcal Vaccine | 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. |
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