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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: placebo (Drug)
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.
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)
时间窗: 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)
时间窗: 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.
次要结局
- Geometric Mean Titer (GMT) of Anti-Influenza Antibody(Day 64 (EOS))
- Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens(Day 64 (EOS))
- Percentage of Participants Who Responded to Each of the 3 Influenza Antigens(Day 64 (EOS))
- Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine(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)(Day 64 (EOS))
- Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)(Day 64 (EOS))
- Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody(Day 64 (EOS))