A COMPREHENSIVE MODEL OF SEVERITY IN OUTCOMES IN ANKYLOSING SPONDYLITIS

强直性脊柱炎严重程度的综合模型

• 批准号: 7952189
• 负责人: MICHAEL H. WEISMAN
• 金额: $ 17.5万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952189
• 关键词: Affect; Aliquot; Ankylosing spondylitis; Arthritis; Biological Markers; Blood; Blood specimen; C-reactive protein; California; Cervical spine; Chronic; Clinical Data; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Consent; Consult; Country; Diagnosis; Disease; Enrollment; Fracture; Funding; Future; Genotype; Grant; Inflammation; Institution; Joints; Laboratories; Lateral; Length; Link; Mails; Measurement; Measures; Modeling; Osteoporosis; Outcome; Pain; Participant; Patients; Pelvis; Peripheral; Persons; Physical Examination; Plasma; Predisposition; Prevalence; Principal Investigator; Questionnaires; Recruitment Activity; Research; Research Personnel; Resources; Rheumatoid Arthritis; Risk; San Francisco; Screening procedure; Sedimentation process; Severities; Site; Source; Spinal; Spinal cord injury; Testing; Texas; Time; United States National Institutes of Health; Universities; Venous blood sampling; Vertebral column; Visit; Woman; bone; flexibility; follow-up; men; psychosocial adjustment; radiologist; ward

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Ankylosing spondylitis (AS) is a chronic inflammatory arthritis that primarily affects the joints of the pelvis and spine. Inflammation in these joints causes pain, stiffness, and limitations in spinal flexibility. Over time, fusion of the joints occurs, leading to complete spinal immobility, secondary osteoporosis, and risk of fracture and spinal cord injury. Peripheral joints may also be involved. The prevalence of AS is 1:1000 persons, and it primarily begins in young adulthood. Men are affected 3 times more often than women. AS is the disease most tightly linked to any marker in the HLA locus, and susceptibility to AS is largely genetically determined. Eligible patients will undergo a simultaneous screening and baseline visit at which time their diagnosis of AS will be confirmed by the study investigators, a Background Information Questionnaire and pain scale will be completed, and phlebotomy will be performed. At this time they will be asked to: 1.) complete an Arthritis Activity Questionnaire; 2.) complete a Psychosocial Adjustment Questionnaire; 3.) have a physical examination of their joints and measurements of spinal flexibility; 4.) have 50 ml of blood drawn for genotyping; 5.) have blood drawn for ESR (sedimentation rate) and CRP (C-Reactive Protein). Both are measures of inflammation; 6.) have radiographs of the pelvis (AP view), lumbar spine (AP and lateral views), and cervical spine (lateral view). Patients that have been enrolled in the PSOAS study will continue to be followed in this study. In addition, we plan to enroll approximately 360 patients newly acquired and recruited for this study at 4 different sites around the country: CSMC, University of California at San Francisco, University of Texas at Houston and the National Institutes of Health. At CSMC, we plan to enroll 120 of those patients. Subjects will be consented for participation by the Principal Investigator when they arrive for their screening/baseline visits in the General Clinical Research Center. Follow-up visits will occur every 6 months after the baseline visit and continue for the length of the study for each patient. Patients will vary in the length of the follow-up period from 2 to 7 years during the time frame of this study because we will be following previously enrolled patients as well as newly acquired patients. At each visit, participants will complete the Arthritis Activity Questionnaire, the Psychosocial Adjustment Questionnaire, have an examination of their joints and measurements of spinal flexibility, and have blood drawn for sedimentation rate and C-reactive protein (measures of inflammation). Radiographs will be repeated every 24 months. Phlebotomy and radiographs will be performed at the enrolling center. All blood samples obtained for this study will be sent for analysis to Dr. John Reveille at the University of Texas at Houston. Testing of ESR and CRP will be done at a commercial laboratory. Serum and plasma for future biomarker analyses will be aliquoted and stored in a -70C freezer at each site for future analysis. All questionnaire and clinical data will be sent to Dr. Michael Ward for analysis at the NIH. Radiographs will be taken digitally, mailed to CSMC on CD and scored by Dr. Thomas Learch, the consulting bone radiologist from USC.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 强直性脊柱炎(AS)是一种慢性炎症性关节炎，主要影响骨盆和脊柱的关节。这些关节的炎症会导致疼痛、僵硬和脊柱灵活性的限制。随着时间的推移，关节会发生融合，导致脊柱完全静止，继发性骨质疏松症，以及骨折和脊髓损伤的风险。周围关节也可能受累。强直性脊柱炎的患病率为1：1000，主要始于青壮年。男性受到影响的频率是女性的3倍。AS与人类白细胞抗原基因座上的任何标记物联系最紧密，AS的易感性在很大程度上是由遗传决定的。 符合条件的患者将同时接受筛查和基线访问，届时他们的AS诊断将由研究调查人员确认，背景信息问卷和疼痛量表将完成，并将进行静脉抽液。此时，他们将被要求：1)填写一份关节炎活动度问卷；填写一份心理社会适应问卷；对他们的关节进行身体检查，并测量脊柱柔韧性；抽取50毫升血液进行基因分型；抽血测定血沉(血沉)和C反应蛋白(C反应蛋白)。两者都是衡量炎症的指标。有骨盆(AP观)、腰椎(AP和侧观)和颈椎(侧观)的X光片。 在这项研究中，已经登记参加腰大肌研究的患者将继续接受跟踪调查。此外，我们计划在全国4个不同的地点招募大约360名新获得和招募的患者参加这项研究：CSMC、加州大学旧金山分校、德克萨斯大学休斯顿分校和美国国立卫生研究院。在CSMC，我们计划招收120名这样的患者。 当受试者到达普通临床研究中心进行筛查/基线检查时，他们将得到首席研究人员的同意参加。 随访将在基线访问后每6个月进行一次，并在每个患者的研究期间继续进行。在这项研究的时间范围内，患者的随访期从2年到7年不等，因为我们将跟踪以前登记的患者和新获得的患者。在每次就诊时，参与者将完成关节炎活动问卷、心理社会适应问卷、关节检查和脊柱柔韧性测量，并抽血检测沉降率和C反应蛋白(炎症测量)。X光照片将每24个月重复一次。 将在招生中心进行静脉抽液和X光检查。 所有为这项研究获得的血液样本都将被送往德克萨斯大学休斯顿分校的约翰·里维尔博士进行分析。血沉和C反应蛋白的测试将在商业实验室进行。用于未来生物标记物分析的血清和血浆将被等分并储存在每个地点的-70C冷冻箱中，以供未来分析。所有问卷和临床数据将被送往迈克尔·沃德博士在NIH进行分析。X光照片将以数字方式拍摄，以CD形式邮寄给CSMC，并由南加州大学的咨询骨放射科医生Thomas Learch博士评分。