PER-069-04未知未知
A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate
适应症
试验速览
研究概览
简要总结
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研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Written and signed informed consent: The patient is willing to participate in the study and sign the informed consent.
- •Patients must meet the criteria of the American Rheumatism Association for the diagnosis of rheumatoid arthritis and the American College of Rheumatology (1991) in Functional Classes I, II or III
- •Patients should have been taking methotrexate for at least 3 months at a weekly dose of at least 15 mg, and at a stable dose for 28 days before treatment (Day 1).
- •Men and women between 18 and 75 years of age
- •Potentially fertile women must present a negative result in the pregnancy test carried out in serum or urine (sensitivity minimum 25 IU / I, or equivalent units of HCG), within 48 hours before the start of the administration of the medication in study
- •Male patients should be using an adequate contraceptive method throughout the study and for up to 10 weeks after the last infusion of abatacept, so that the risk of pregnancy in their partner is minimized.
排除标准
- •Women of childbearing age who are unwilling or unable to use a method of birth control that is acceptable throughout the study and for a period of up to 10 weeks after the last infusion of abatacept.
- •Women of childbearing age who are using a method of prohibited birth control.
- •Pregnant or lactating women.
- •Women who have obtained a positive result in the pregnancy test performed during the enrollment or before the administration of the study drug.
- •Men who are not willing or able to use a long contraceptive method throughout the study and for a period of up to 10 weeks after the last infusion of the study medication.
- •Patients who are disabled, disabled, or unable to complete the study evaluations.
- •Any previous or concurrent medical condition that has contraindications to the use of TNF blocking agents.
- •Patients who have previously received treatment with approved biological therapy for RA (infliximab, etanercept, anakinra, adalimumab).
- •Patients who have failed more than 3 oral DMARDs.
- •Patients with active vasculitis of a larger organic system (except for subcutaneous rheumatoid nodules).
- •Current symptoms of renal, hepatic, hematological disease. Gastrointestinal, pulmonary, cardiac, neurological or cerebral that is severe, progressive or not controlled. Concomitant medical conditions that, in the opinion of the Investigator, would place the subject at an unacceptable risk if they participated in this study.
- •Female patients, who have not had an evaluation for breast cancer screening according to age and / or appropriate risk factors (defined by the published guidelines and / or local standards endorsed by the national cancer institute or medical society and / or the Ministry of Health), or that have presented an evaluation for breast cancer that is suspicious of neoplasia, and in whom the possibility of neoplasia can not be reasonably excluded after clinical, laboratory or other diagnostic evaluation.
- •Patients with a history of cancer in the last 5 years (less in the case of non-melanoma skin tumor cured with local resection). Existing non-melanoma skin tumors should be removed before treatment.
- •Patients who have a clinically significant history of alcohol or drug abuse. Patients who are currently under treatment with methotrexate or leflunomide and admit to consuming more than 1 alcoholic beverage per day on average.
- •Patients with a severe bacterial infection (such as pneumonia or pyelonephritis), unless treated and completely treated with antibiotics.
- •Patients with severe chronic or recurrent bacterial infections (such as recurrent pneumonia, chronic bronchiectasis).
- •Patients with active tuberculosis (TB) who required treatment in the previous 3 years. Patients with a positive PPD test result in the selection will not be eligible for the study unless active TB infection has been ruled out, have started treatment for latent TBC at least 4 weeks before treatment with the medication of the study, and have a negative chest x-ray at the time of enrollment. A PPD response equal to or greater than 10 mm will be considered positive, although a lower threshold (5 mm) may be applied as determined by the clinical circumstances and the investigator, in accordance with published recommendations and / or local regulations supported by the company. medical
- •Patients with herpes zoster who remitted less than 2 months before enrollment.
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