A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 84
- 主要终点
- Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion
研究概览
简要总结
This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than eight weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patients, ≥ 18 years of age
- •Rheumatoid arthritis of ≥ 6 months duration, diagnosed according to the revised 1987 American College of Rheumatology criteria
- •Inadequate response to at least one approved anti-TNF agent (adalimumab, etanercept, infliximab, golimumab, or certolizumab)
- •Patients who have received 1 to 2 prior courses of rituximab (RTX) may be enrolled, provided their most recent course of RTX occurred over 6 months but no more than 9 months prior to baseline. The RTX dosage must have been two 1000 mg infusions per course administered at the standard approved rate
- •Methotrexate treatment between 10 and 25 mg/week (oral or parenteral) for at least 8 weeks immediately prior to baseline
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following baseline
- •Rheumatic autoimmune disease other than rheumatoid arthritis
- •Functional class IV as defined by American College of Rheumatology (ACR) criteria
- •Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- •History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- •Previous serious infusion reaction to any prior biologic therapy
- •Known active current or history of recurrent infection
- •Evidence of chronic hepatitis B or C infection
- •Pregnant or lactating women
- •Body weight of > 150 kg
研究组 & 干预措施
Rituximab
Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
干预措施: rituximab (Drug)
Rituximab
Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
干预措施: methotrexate (Drug)
Rituximab
Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
干预措施: methylprednisolone (Drug)
Rituximab
Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
干预措施: acetaminophen (Drug)
Rituximab
Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
干预措施: antihistamine (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion
时间窗: Within 24 hours of beginning infusion on Day 15
The primary criterion for assessing safety of the faster infusion was the incidence of infusion related reaction (IRRs). IRRs were adverse events (AEs) that occurred within 24 hours of beginning infusion that were among a pre-specified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA). "Incidence" is defined as the percentage of participants experiencing an IRR.
次要结局
- Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion(Within 24 hours of beginning infusion on Day 168)
- Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion(Within 24 hours of beginning infusion on Day 15)
- Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion(Within 24 hours of beginning infusion on Day 15)
- Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion(Within 24 hours of beginning infusion on Day 168)
- Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion(During the infusion (a 2-hour period) on Day 168)
- Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion(During the infusion (a 2-hour period) on Day 15)