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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01359150
• Date of registration: 11/05/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: 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
• Scientific 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
• Date of first enrolment: September 2011
• Target sample size: 223
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01359150
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Poland, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: CP-690,550

Drug: placebo

Primary Outcome(s)

Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) [Time Frame: Day 64 (EOS)]

Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) [Time Frame: Day 64 (End of Study [EOS])]

Secondary Outcome(s)

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)]

Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody [Time Frame: 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)]

Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine [Time Frame: Day 64 (EOS)]

Percentage of Participants Who Responded to Each of the 3 Influenza Antigens [Time Frame: Day 64 (EOS)]

Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens [Time Frame: Day 64 (EOS)]

Geometric Mean Titer (GMT) of Anti-Influenza Antibody [Time Frame: Day 64 (EOS)]

Secondary ID(s)

A3921129

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/03/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01359150