Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in RA and Spondyloarthritis Patients, Treated With TNFalpha-inhibitors in Combination With Methotrexate or Methotrexate or TNFalpha-inhibitors Alone - a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- To examine the association between inflammatory disease activity and endothelial function in RA and spondyloarthritis patients treated with methotrexate and TNFalpha-inhibitor in combination or methotrexate or TNFalpha-inhibitor alone
研究概览
简要总结
The aim of this study is to examine the associations between inflammatory disease activity and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial function, and decrease in bone and cartilage destruction during treatment with the combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18-80 years
- •Able and willing to give written informed consent, and to comply with the requirements of the study protocol.
- •Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis, or the diagnostic criteria by Moll and Wright for the diagnosis psoriatic arthritis, or the modified New York diagnostic criteria for ankylosing spondylitis.
- •Clinical indication for starting treatment with methotrexate, TNFalpha- inhibitor or combination therapy.
- •Use of reliable method of contraception for women with childbearing potential.
排除标准
- •Lack of cooperativity
- •Positive serology for hepatitis B or C
- •History of positive HIV status.
- •History of tuberculosis or untreated tuberculosis.
- •PPD more than 15 mm in previously BCG immunized subjects. PPD 6 mm or more if not previously BCG immunized.
- •Histoplasmosis or Listeriosis
- •Persistent or recurrent infections
- •Any inflammatory disease of permanence not related to RA, PSA or AS.
- •Pregnancy or breast-feeding.
- •Use of prednisolone more than 10 mg daily for 2 weeks at inclusion.
- •Use of TNFalpha-inhibitor the last 4 weeks.
- •History of cancer.
- •Uncontrolled diabetes.
- •Congestive heart failure (Nyha 3-4)
- •Recent stroke (within 3 months)
- •Previous diagnosis or signs of central nervous system demyelinating disease.
- •Previously diagnosed immunodeficiency.
结局指标
主要结局
To examine the association between inflammatory disease activity and endothelial function in RA and spondyloarthritis patients treated with methotrexate and TNFalpha-inhibitor in combination or methotrexate or TNFalpha-inhibitor alone
时间窗: Baseline (before treatment starts), 6 weeks and 6 months after starting treatment
次要结局
- COMP (cartilage oligomeric matrix protein 1)(Baseline (before starting treatment), 6 weeks, 6 months after starting treatment)
- CRP (C-reactive protein)(Baseline (before starting treatment), 6 weeks, 6 months after starting treatment)
- s-RAGE (Receptor of Advanced Glycation End products)(Baseline (before starting treatment), 6 weeks, 6 months after starting treatment)
- DAS28 (Disease activity score)(Baseline (before starting treatment), 6 weeks, 6 months after starting treatment)
- IL-6 (interleukin 6)(Baseline (before starting treatment), 6 weeks, 6 months after starting treatment)