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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01359150
First received: May 11, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: CP-690,550
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) [ Time Frame: Day 64 (End of Study [EOS]) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens [ Time Frame: Day 64 (EOS) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 223
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359150

  Show 57 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01359150     History of Changes
Other Study ID Numbers: A3921129
Study First Received: May 11, 2011
Results First Received: January 7, 2013
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Influenza, Human
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Methotrexate
Tofacitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 14, 2014