EUCTR2008-006885-27-NL进行中（未招募）不适用
EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS
Clinical Immunology and Rheumatology0 个研究点开始时间: 2008年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Prior to any study procedure, voluntary written informed consent must be obtained, after the nature and purpose of this study are explained
- •2.Patients should be between 18 and 70 years of age
- •3.Patients must have a diagnosis of peripheral spondyloarthritis not fulfilling the classification criteria for AS or PsA (see appendix 1) for at least 3 months. The disease must be moderate to severely active as defined by ? 1 swollen and ? 1 tender or painful joints
- •4.If female, patient should either be of not-childbearing potential (i.e. postmenopausal or surgically sterile) or practice a reliable method of birth control until 150 days post-study (e.g. use of condom, IUD, oral contraceptives) or have a vasectomized partner
- •5.Patients should have inadequate response to NSAID therapy
- •6.The use of concomitant NSAIDs and corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent = 10 mg/day and must be stable for at least 4 weeks prior to baseline
- •7.The use of concomitant DMARDs (methotrexate or sulphalazine) is allowed. If using DMARDs, patients must have received a minimum of 3 months of therapy and be on a stable dose for at least 4 weeks prior to baseline
- •8.Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest ?X-ray and ECG
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be considered ineligible for study participation is any of the following criteria are met:
- •1.Patient has previously received anti-TNF therapy or another investigational drug in the past 2 months
- •2.Patient has received an intra-articular injection with corticosteroids within 4 weeks prior to baseline
- •3.Patient has an active articular disease (other than peripheral spondyloarthritis not fulfilling the classification criteria for AS or PsA) that could interfere with the assessment of arthritis
- •4.Patient has a history of active tuberculosis. A PPD test and chest X-ray done at screening should be negative (in case of latent tuberculosis, a patient may enter the study if prophylaxis with isoniazide is begun prior to administration of adalimumab)
- •5.Patients has a recent history of (or persistent) infection requiring hospitalization or antibiotic treatment within 4 weeks of baseline
- •6.Patient has a significant history of cardiac, renal, neurological, metabolic or any other disease that may affect his/her participation in this study
- •7.Patient has a history of malignancy (other than basal cell carcinoma of the skin) in the past 10 years
- •8.If female, patient should not be pregnant or breast-feeding. A serum pregnancy-test will be performed at screening has to be negative
- •9.Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
研究者
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