A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 112
- 试验地点
- 36
- 主要终点
- Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
研究概览
简要总结
This study will evaluate immune response following administration of zoster vaccine in subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5 mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have moderate to severe rheumatoid arthritis inadequately controlled by methotrexate as defined by the American College of Rheumatology (ACR) classification criteria for Rheumatoid arthritis, painful and swollen joint counts and C-reactive protein (CRP).
- •Screening CRP >3 mg/L or CDAI score > 10 at screening or at baseline before vaccination.
- •Subjects must have active disease at screening and baseline.
- •Must be at least 50 years of age or older.
排除标准
- •History of receiving any varicella-zoster virus vaccine
- •Receipt of any vaccines within 6 weeks of first dose of study treatment.
- •Subjects with current infections or history of infections.
- •History of recurrent (more than one episode) of herpes zoster or disseminated (a single episode) of herpes zoster or disseminated (a single episode) of herpes simplex.
研究组 & 干预措施
Tofacitinib 5 mg BID (oral) (70 subjects)
Zoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
干预措施: Tofacitinib (Drug)
Placebo tofacitinib BID (oral) (70 subjects)
Zoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
时间窗: Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)
VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).
次要结局
- Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12(Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination))
- Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12(Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination))
- Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12(Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination))