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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

Tracking Information
First Submitted Date  ICMJE May 11, 2011
First Posted Date  ICMJE May 24, 2011
Results First Submitted Date  ICMJE January 7, 2013
Results First Posted Date  ICMJE March 29, 2013
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • Percentage of subjects achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentrations from vaccination baseline (Visit 2) in ≥6 of 12 anti-pneumococcal antigens measured at Visit 3. [ Time Frame: visit 2 (week 4) and 3 (week 9) ]
  • Percentage of subjects achieving a satisfactory humoral response to the influenza vaccine as defined by ≥4-fold increase in antibody titers from vaccination baseline (Visit 2) in ≥2 of 3 influenza antigens measured at Visit 3. [ Time Frame: visit 2 (week 4) and 3 (week 9) ]
Change History Complete list of historical versions of study NCT01359150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • Percentage of subjects who respond to each of the 12 pneumococcal antigens as defined by ≥2-fold increase in antibody concentrations from vaccination baseline (Visit 2) measured at Visit 3. [ Time Frame: visit 2 and 3 ]
  • Percentage of subjects achieving protective titers to the influenza vaccine as measured by a hemagglutination inhibition assay titer of ≥1:40 in ≥2 of 3 influenza antigens measured at Visit 3. [ Time Frame: visit 2 and 3 ]
  • Percentage of subjects who respond to the 3 influenza antigens as defined by ≥4-fold increase in antibody titers from vaccination baseline measured at Visit 3. [ Time Frame: visit 2 and 3 ]
  • Increase of anti-pneumococcal antibody levels to each of the 12 pneumococcal antigens above vaccination baseline values (Visit 2) at Visit 3 [ Time Frame: visit 2 and 3 ]
  • Increase of anti-influenza antibody levels to the 3 influenza antigens above vaccination baseline values (Visit 2) at Visit 3. [ Time Frame: visit 2 and 3 ]
  • The concentrations of anti-pneumococcal antibodies measured at Visit 3 in all subjects [ Time Frame: visit 3 ]
  • Titers of anti-influenza antibodies measured at Visit 3 in all subjects [ Time Frame: visit 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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).
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: CP-690,550
  • 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.
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2013)
223
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
200
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01359150
Other Study ID Numbers  ICMJE A3921129
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP