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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359150
• Other study ID #: A3921129
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2011
• Last updated: February 20, 2013
• Start date: September 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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
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

Locations

Country	Name	City	State
Poland	Pfizer Investigational Site	Cieszyn
Poland	Pfizer Investigational Site	Koscian
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Torun
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Wroclaw
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Bethlehem	Pennsylvania
United States	Pfizer Investigational Site	Bingham Farms	Michigan
United States	Pfizer Investigational Site	Binghamton	New York
United States	Pfizer Investigational Site	Boulder	Colorado
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Clarksburg	West Virginia
United States	Pfizer Investigational Site	Columbia	Missouri
United States	Pfizer Investigational Site	Columbia	Missouri
United States	Pfizer Investigational Site	Cumberland	Maryland
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Edina	Minnesota
United States	Pfizer Investigational Site	Fair Oaks	California
United States	Pfizer Investigational Site	Gilbert	Arizona
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jonesboro	Arkansas
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Leominster	Massachusetts
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Mesquite	Texas
United States	Pfizer Investigational Site	Minot	North Dakota
United States	Pfizer Investigational Site	Morton Grove	Illinois
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Olean	New York
United States	Pfizer Investigational Site	Paradise Valley	Arizona
United States	Pfizer Investigational Site	Port Richey	Florida
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Rockford	Illinois
United States	Pfizer Investigational Site	Rocky Mount	North Carolina
United States	Pfizer Investigational Site	Roseville	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Trumbull	Connecticut
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	Vancouver	Washington
United States	Pfizer Investigational Site	Vernon Hills	Illinois
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Worcester	Massachusetts
United States	Pfizer Investigational Site	Worcester	Massachusetts
United States	Pfizer Investigational Site	Wyomissing	Pennsylvania
United States	Pfizer Investigational Site	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 64 (End of Study [EOS])	No
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.	Day 64 (EOS)	No
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.	Day 64 (EOS)	No
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.	Day 64 (EOS)	No
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.	Day 64 (EOS)	No
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.	Day 64 (EOS)	No
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.	Day 64 (EOS)	No
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.	Day 64 (EOS)	No
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.	Day 64 (EOS)	No

External Links

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