PER-005-05已完成未知
Randomized, double-blind, placebo-controlled, dose-range study to assess the safety and efficacy of oral TAK-715 in the treatment of signs and symptoms of rheumatoid arthritis
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
- 性别
- All
入选标准
- •a) The patient is able to comply with the protocol and has signed the informed consent form
- •b) The subject is a man or woman 18 years of age or older, diagnosed with rheumatoid arthritis
- •c) Women who are able to conceive should not be pregnant or breastfeeding
- •d) The patient must have undergone a physical examination that in the opinion of the researcher, does not demonstrate clinically significant abnormalities
- •e) The patient must have laboratory tests whose results are normal or if abnormal, are not clinically significant
- •f) The patient must have a normal electrocardiogram or if abnormal, it should not be clinically significant
- •g) The patient should have a chest radiograph that shows no signs of active tuberculosis or clinically significant findings.
- •h) The patient should have a negative skin test of the purified protein derivative (PPD)
- •i) The patient must have been receiving methotrexate orally or parenterally for at least 6 months before and should receive a stable dose of methotrexate for at least 4 weeks before the baseline visit.
- •j) In the selection and baseline visits, the patient must have at least 6 inflamed joints and 9 painful joints
- •k) At the screening visit, the patient should have a CRP of at least 1.2 mg / dL or an ESR of at least 28 mm / hour.
- •1) If a patient is taking a systemic corticosteroid, the maintenance dose of prednisone or its equivalent should remain stable for at least 4 weeks, may not exceed 10 mg / day and the patient should continue with that stable dose throughout the study.
- •m) If a patient is taking an NSAID for the treatment of rheumatoid arthritis, the maintenance dose of NSAID should remain stable for at least 4 weeks before the baseline visit and the patient should continue with that stable dose throughout the study
排除标准
- •a) The patient has been diagnosed with any type of arthritis at 16 years of age or earlier.
- •b) The patient has a clinically relevant history of disease.
- •c) The patient has a known history of human immunodeficiency virus (HIV) infection.
- •d) The patient has a known history of hepatitis B or C.
- •e) The patient has uncontrolled hypertension.
- •f) The patient has moderate or severe liver disease.
- •g) The patient has a high serum creatinin
- •h) The patient has a hemoglobin less than 9.0 mg / dL, a white blood cell count less than 3,000 / inn or a platelet count less than 100,000 / mm3
- •i) The patient has a functional status IV for rheumatoid arthritis
- •j) The patient has used an antirheumatic disease modifier drug (DMARD) or
- •a biological agent other than methotrexate in the previous 8 weeks
- •k) The patient has failed treatment due to lack of efficacy with any anti-TNF agent.
- •l) The patient has failed due to lack of efficacy with more than 2 DMARDs m) The patient has received any intra-articular, intramuscular or intravenous corticosteroid within the previous 4 weeks
- •n) The patient has received an alkylating agent.
- •o) The patient has a high risk of opportunistic infection
- •p) The patient has antecedents of, or a current inflammatory condition with signs and symptoms that could confuse the diagnosis of rheumatoid arthritis
- •q) The patient has been diagnosed with secondary, non-inflammatory arthritis.
- •r) The patient has a history of drug abuse within the past 2 years.
- •s) The patient has a BMI greater than 35
- •t) The patient has a previous history of cancer, other than basal cell carcinoma , which has not been in remission for at least 5 years before
- •u) The patient does not want or is not able to comply with the protocol
- •v) The patient can not understand written or spoken English or any other language in which a certified translation of the approved informed consent is available.
- •w) The patient has known hypersensitivity to TAK-715 or its components.
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