Spondyloarthropathy in Inflammatory Bowel Disease Patients and Evaluation of Its Response to TNF Inhibitors in Assiut University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- prevalence of SPA in IBD patients
研究概览
简要总结
Prevelance of axial spondylosis arthritis in inflammatory bowel disease and its RESPONSE to tumour necrosis factor (TNF) inhibitors TREATMENT
详细描述
Inflammatory bowel disease [IBD], encompassing Crohn's disease and ulcerative colitis, represents a chronic inflammatory disease entity that mainly affects the gastrointestinal tract.1 Extraintestinal manifestations, however, frequently occur and may involve different organ systems.2 Among the most common extraintestinal manifestations are spondyloarthritis [SpA], here defined as ankylosing spondylitis, psoriatic arthritis, enteropathic arthritis, reactive arthritis, and undifferentiated spondyloarthritis diagnosis.3 This group of rheumatic diseases share a similar clinical presentation with involvement of the spine, sacroiliac joints, peripheral arthritis, and frequently also enthesitis.4 Both IBD and SpA are also highly heritable diseases, and genome-wide and family-based association studies have demonstrated evidence of a shared genetic basis between IBD and SpA.5-6 Comorbidity with SpA has been associated with disability and decreased quality of life in IBD patients.7 In some IBD patients, these complications of SpA can lead to greater morbidity than the typical gastrointestinal symptoms for IBD.8 Even though lower back pain is commonly reported by IBD patients with SpA, early symptoms related to SpA may be mild and not always recognisable. However, an early diagnosis of SpA is important since a delayed diagnosis may potentially lead to a more severe disease course and poor treatment responses in patients with SpA.9 Infliximab is a genetically constructed immunoglobulin (Ig)G1 murine-human chimeric monoclonal antibody that binds the soluble subunit and the membrane-bound precursor of tumor necrosis factor-α (TNF-α). Consequently, it helps to decrease the biological activity of TNF-α (10). Neutralization of TNF-α has been suggested as a therapeutic strategy for patients with inflammatory bowel disease (IBD), rheumatoid arthritis (RA), spondyloarthropathy (SpA) and various other chronic inflammatory conditions (11).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBD patients (ulcerative colitis , Crohn's disease )on TNF inhibitors Data collected included SPA and IBD variables, demographics, concurrent medications, co-morbidities and autoimmune serology.
- •They fulfil criteria of axial SPA Clinical Criteria 12 Low back pain ≥ 3 months, improved by exercise and not relieved by rest Limitation of lumbar spine in sagittal and frontal planes Limitation of chest expansion (relative to normal values corrected for age and sex) Radiological Criteria Bilateral grade 2-4 sacroiliitis, or; Unilateral 3-4 sacroiliitis Assessment of disease activity of SPA 13 Patient fulfill criteria of IBD 14 Assessment of IBD activity (Esr , CRP ,Faecal calprotectin , CBC , albumin ,endoscopy, histopathology) Mayo score for U.C Crohn's disease Activity index
排除标准
- •Other autoimmune disease , DM, LCF ,CRF ,Malignancy , Mechanical low back pain, Fracture , Spondylolisthesis , Spine tumores , Kidney stones .
研究组 & 干预措施
(TNF) inhibitors
1- Patients taking biologic (infliximab) treatment
干预措施: TNF inhibitors (Drug)
conventional IBD medical Treatment
patients taking conventional IBD medical Treatment
干预措施: conventional ibd medical treatment (Drug)
结局指标
主要结局
prevalence of SPA in IBD patients
时间窗: baseline
次要结局
未报告次要终点
研究者
Mohamed Nasr
Mohamednasr
Assiut University
