NL-OMON32839尚未招募2 期
Efficacy and safety of adalimumab in patients with peripheral spondyloarthritis without ankylosing spondylitis or psoriatic arthritis. - Adalimumab in peripheral spondyloarthritis without AS or PsA
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
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 99（—）
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 ankylosing spondylitis or psoriatic arthritis for at least 3 months. The disease must be moderate to severely active as defined by at least 1 swollen and at least 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 (non-steroidal, anti-inflammatory drugs)
- •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 (disease modifying anti-rheumatic drugs, Methotrexaat or Sulphasalazine) 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
排除标准
- •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 ankylosing spondylitis or psoriatic arthritis) 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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