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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

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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

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: CP-690,550 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359150


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Locations
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United States, Arizona
Pfizer Investigational Site
Gilbert, Arizona, United States, 85234
Pfizer Investigational Site
Paradise Valley, Arizona, United States, 85253
United States, Arkansas
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
Pfizer Investigational Site
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
United States, Colorado
Pfizer Investigational Site
Boulder, Colorado, United States, 80304
United States, Connecticut
Pfizer Investigational Site
Trumbull, Connecticut, United States, 06611
United States, Florida
Pfizer Investigational Site
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
United States, Illinois
Pfizer Investigational Site
Morton Grove, Illinois, United States, 60053
Pfizer Investigational Site
Rockford, Illinois, United States, 61107
Pfizer Investigational Site
Vernon Hills, Illinois, United States, 60061
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67208
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40504
United States, Maryland
Pfizer Investigational Site
Cumberland, Maryland, United States, 21502
United States, Massachusetts
Pfizer Investigational Site
Leominster, Massachusetts, United States, 01453
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01605
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01608
United States, Michigan
Pfizer Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, Minnesota
Pfizer Investigational Site
Edina, Minnesota, United States, 55435
United States, Missouri
Pfizer Investigational Site
Columbia, Missouri, United States, 65203
Pfizer Investigational Site
Columbia, Missouri, United States, 65212
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New York
Pfizer Investigational Site
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
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
Rocky Mount, North Carolina, United States, 27804
United States, North Dakota
Pfizer Investigational Site
Minot, North Dakota, United States, 58701
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States, 45417
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Pfizer Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Pfizer Investigational Site
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29601
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37909
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Mesquite, Texas, United States, 75150
United States, Washington
Pfizer Investigational Site
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
United States, West Virginia
Pfizer Investigational Site
Clarksburg, West Virginia, United States, 26301
Poland
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01359150     History of Changes
Other Study ID Numbers: A3921129
First Posted: May 24, 2011    Key Record Dates
Results First Posted: March 29, 2013
Last Update Posted: March 29, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Tofacitinib
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors