NCT00794898已完成4 期
Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Define the onset of efficacy of infliximab in patients with active RA, using the validated SF-36 questionnaire.
研究概览
简要总结
This is an open-label program of Remicade in the treatment of patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX) to determine the onset of efficacy of infliximab.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, >=18 to <=75 years of age.
- •Diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al., 1988). The disease should have been diagnosed at least 6 months prior to Screening.
- •Patients have active disease, in the opinion of the physician, despite the concomitant use of DMARDS. Evidence of active disease may include any of the following:
- •6 or more swollen or tender joints; and 2 of the following
- •Morning stiffness >45 minutes
- •C-reactive protein >2.0 mg/L
- •ESR >28 mm/h
- •Patients must have been using oral or parenteral MTX for at least 2 months with no break(s) in treatment of more than 2 weeks total during this period. Patients must have been on a stable dose of >=7.5 mg/wk (IM, SQ, PO) for at least 8 weeks prior to Screening.
- •Men and women of childbearing potential must be using adequate birth control measures (abstinence, oral contraceptives, IUD, barrier method with spermicide or, surgical sterilization) and should continue such precautions for 6 months after receiving the last infusion.
- •Patients must be on a stable dose of folic acid prophylaxis for at least 4 weeks prior to Screening.
- •Patients using oral corticosteroids or NSAIDs, must have been on a stable dose for at least 4 weeks prior to Screening, and must continue during the treatment period. If currently not using corticosteroids or NSAIDs, the patient must have not received corticosteroids or NASIDs for at least 4 weeks prior to Screening.
- •Patients must be able to adhere to the program visit schedule and other protocol requirements.
- •Patients must be capable of giving informed consent and the consent must have been obtained prior to any screening procedures.
排除标准
- •Pregnant women, nursing mothers or a planned pregnancy within 1.5 years of enrollment
- •Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
- •Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the Remicade therapy, eg, Lyme disease, or a rheumatic disease other than RA.
- •Use of DMARDS other than MTX within 4 weeks prior to Screening.
- •Use of intra-articular, IM, or IV. corticosteroids (including IM ACTH) within 4 weeks prior to Screening.
- •Prior administration any other therapeutic agent targeted at reducing TNF (eg, Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous 6 months.
- •Treatment with any investigational drug within the previous 6 months.
- •A history of known allergies to murine proteins.
- •Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection need not be considered exclusions at the discretion of the treating physician.
- •History of opportunistic infections such as herpes zoster within 2 months of Screening. Evidence of active CMV, active pneumocystis carinii, drug resistant atypical mycobacterium, etc.
- •Documented HIV infection.
- •Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
- •Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past 5 years.
- •Patients with alcoholism, alcoholic liver disease, or other chronic liver disease.
- •Patients with a positive PPD within 3 months and chest X-Ray suggestive of active TB or a previous exposure to TB.
- •Patients with CHF, even if asymptomatic or not requiring medication must be excluded.
结局指标
主要结局
Define the onset of efficacy of infliximab in patients with active RA, using the validated SF-36 questionnaire.
时间窗: After the first 2 weeks of treatment.
次要结局
未报告次要终点
研究者
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