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

February 20, 2013 updated by: Pfizer

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid Arthritis receiving CP-690,550 with and Without background Methotrexate

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
223

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Cieszyn, Poland, 43-400
        • Pfizer Investigational Site
      • Koscian, Poland, 64-000
        • Pfizer Investigational Site
      • Poznan, Poland, 60-773
        • Pfizer Investigational Site
      • Torun, Poland, 87-100
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-256
        • Pfizer Investigational Site
      • Wroclaw, Poland, 50-088
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Pfizer Investigational Site
      • Paradise Valley, Arizona, United States, 85253
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
    • California
      • Fair Oaks, California, United States, 95628
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Roseville, California, United States, 95661
        • Pfizer Investigational Site
      • Upland, California, United States, 91786
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Pfizer Investigational Site
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Naples, Florida, United States, 34102
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Pfizer Investigational Site
      • Port Richey, Florida, United States, 34668
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
      • Zephyrhills, Florida, United States, 33542
        • Pfizer Investigational Site
    • Illinois
      • Morton Grove, Illinois, United States, 60053
        • Pfizer Investigational Site
      • Rockford, Illinois, United States, 61107
        • Pfizer Investigational Site
      • Vernon Hills, Illinois, United States, 60061
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Pfizer Investigational Site
    • Massachusetts
      • Leominster, Massachusetts, United States, 01453
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01605
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01608
        • Pfizer Investigational Site
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Pfizer Investigational Site
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Pfizer Investigational Site
      • Binghamton, New York, United States, 13905
        • Pfizer Investigational Site
      • Olean, New York, United States, 14760
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • Rocky Mount, North Carolina, United States, 27804
        • Pfizer Investigational Site
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Mesquite, Texas, United States, 75150
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98122
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
      • Vancouver, Washington, United States, 98664
        • Pfizer Investigational Site
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.
  • The subject must have active disease at both screening and baseline

Exclusion Criteria:

  • History of any documented influenza or pneumococcal infection within the last 3 months.
  • Receipt of any vaccine within 1 month prior to the initial study drug administration (CP-690,550 or placebo CP-690,550).
  • If a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group 1: 10 mg BID CP-690,550 (100 subjects).
CP-690,550 will be administered for 4 weeks, vaccines will be administered at week 4. CP-690,550 will then continue for another 5 weeks at which point the immune response will be evaluated.
Drug: CP-690,550
Treatment Group 1: 10 mg BID CP-690,550 (100 subjects). Strata 1: 10 mg BID CP-690,550 on background methotrexate (50 subjects); Strata 2: 10 mg BID CP-690,550 monotherapy (50 subjects).
Placebo Comparator: Treatment Group 2:Placebo CP-690,550 (100 subjects).
Placebo will be administered for 4 weeks, vaccines will be administered at week 4. Placebo will then continue for another 5 weeks at which point the immune response will be evaluated.
Drug: placebo
Placebo CP-690,550 (100 subjects). Strata 1: Placebo CP-690,550 on background methotrexate (50 subjects); Strata 2: Placebo CP-690,550 monotherapy (50 subjects). Influenza and pneumococcal vaccines will be administered to all subjects

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)
Time Frame: Day 64 (End of Study [EOS])
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.
Day 64 (End of Study [EOS])
Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)
Time Frame: Day 64 (EOS)
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.
Day 64 (EOS)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens
Time Frame: Day 64 (EOS)
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.
Day 64 (EOS)
Percentage of Participants Who Responded to Each of the 3 Influenza Antigens
Time Frame: Day 64 (EOS)
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.
Day 64 (EOS)
Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine
Time Frame: Day 64 (EOS)
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.
Day 64 (EOS)
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)
Time Frame: Day 64 (EOS)
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.
Day 64 (EOS)
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)
Time Frame: Day 64 (EOS)
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.
Day 64 (EOS)
Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody
Time Frame: Day 64 (EOS)
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.
Day 64 (EOS)
Geometric Mean Titer (GMT) of Anti-Influenza Antibody
Time Frame: Day 64 (EOS)
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.
Day 64 (EOS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3921129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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