A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response
研究概览
简要总结
The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease Activity Score 28 [DAS 28]) to those participants with severe RA (defined as having a score greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX. DAS evaluates RA activity by several parameters including the number of swollen and tender joints and the participant's own assessment of their pain. Participants will receive infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein) (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 Weeks. Participants will have a follow-up visit on Week 26. Efficacy will primarily be assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week 26. Participants' safety will be assessed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have a definitive diagnosis of rheumatoid arthritis (RA) based on the American College of Rheumatology Criteria 1987
- •Participants must have been on Methotrexate (MTX) for 12 weeks at the stable dose for at least 4 weeks
- •Participants using oral corticosteroids, must have been on a stable dose of prednisone less than 10 milligram per day (mg/day) or its equivalent for at least 4 weeks before screening or if currently not using corticosteroids, the participant must not have received corticosteroids for at least 4 weeks before screening
- •Participants with moderate to severe RA (Disease Activity Score [DAS28] greater than 3.2)
- •Male participants shall adopt contraceptive measures during the trial and within 6 months after the completion of trial (such as spermicidal barrier), or their female sexual partners shall agree to adopt effective contraceptive measures during the trial or within 6 months after the completion of trial (such as oral contraceptives, contraceptives for injection, intrauterine device [IUD], or sterilization by surgery); female participants of childbearing potential with negative urine pregnancy test upon enrollment in addition to adopting the said contraceptive measures
排除标准
- •Participant who has a known allergy to human immunoglobulin proteins or other components of infliximab
- •Participant who has a history of receiving infliximab or any other biological preparations
- •Participant who is in stage IV RA evaluated by X-ray
- •Participants suffering from tuberculosis
- •Female participant or male participant's wife who plans to become pregnant during this study and within 6 months after completion of this study
研究组 & 干预措施
Infliximab + Methotrexate (Moderate RA)
Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
干预措施: Infliximab (Drug)
Infliximab + Methotrexate (Moderate RA)
Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
干预措施: Methotrexate (Drug)
Infliximab + Methotrexate (Severe RA)
Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (mg/week) equal to the dose used before participation in the study) for 22 weeks.
干预措施: Infliximab (Drug)
Infliximab + Methotrexate (Severe RA)
Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (mg/week) equal to the dose used before participation in the study) for 22 weeks.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response
时间窗: Week 26
ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire \[HAQ\]) and C-reactive protein (CRP).
Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response
时间窗: Week 26
ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire \[HAQ\]) and C-reactive protein (CRP).
Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response
时间窗: Week 26
ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire \[HAQ\]) and C-reactive protein (CRP).
次要结局
- Change From Baseline in Swollen Joints Count at Week 26(Baseline and Week 26)
- Change From Baseline in Tender Joints Count at Week 26(Baseline and Week 26)
- Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26(Baseline and Week 26)
- Change From Baseline in Participants' Global Disease Assessment at Week 26(Baseline and Week 26)
- Change From Baseline in Physicians' Global Disease Assessment at Week 26(Baseline and Week 26)
- Change From Baseline in Duration of Morning Stiffness at Week 26(Baseline and Week 26)
- Change From Baseline in C-Reactive Protein (CRP) at Week 26(Baseline and Week 26)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26(Baseline and Week 26)
- Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26(Baseline and Week 26)