Efficacy of Doxycycline as a Combination Therapy in the Treatment of Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- efficacy of doxycycline
研究概览
简要总结
Rheumatoid Arthritis (RA) is a chronic inflammatory disease characterized by joint swelling, joint tenderness and destruction of synovial joints, leading to severe disability and premature mortality.
详细描述
The rate of cartilage and joint damage in RA is correlated with plasma elevations in inflammatory acute phase reactants, such as C- reactive protein and erythrocyte sedimentation rate, rheumatoid factor positivity and the synovial concentrations of matrix metalloproteinases(MMP), a matrix digesting enzymes directly responsible for joint destruction.
Matrix metalloproteinases (MMP) are a family of zinc-containing endoproteinases that degrade extracellular matrix (ECM) components.The MMPs are thought to play a critical role in the degradation of many components of the extracellular matrix in the synovial joint.
Matrix metalloproteinase-3 (stromelysin-1) is a proteolytic enzyme which is thought to play a pivotal role in joint destruction in RA through breaking down various extracellular components, including collagens (types III, IV, V, IX, and XI), matrix proteins and proteoglycans and activating other pro-MMPs such as pro-MMP-7, pro-MMP-8 and pro-MMP-9.
In RA, MMP-3 is locally produced in the inflamed joint and released into the blood stream. It has been suggested that serum MMP-3 level correlates with levels produced by the synovium, thus reflect the level of activity of rheumatoid synovitis.
MMP-9 has been associated with chronic inflammatory autoimmune diseases. It has been implicated in the pathogenesis of autoimmune diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients included in this study are patients with RA (either newly or previously diagnosed) with their age between 18-50 years old having the same normal range of body mass index
排除标准
- •The investigators will exclude patients with risk factors for atherosclerosis other than rheumatoid arthritis such as:
- •Hypertension.
- •Diabetes.
- •History of renal or liver diseases.
- •Corticosteroid therapy. 2- Intercurrent infections as they may interfere with levels of metalloproteinases.
- •3- Pregnant or lactating females .
研究组 & 干预措施
RA patients treated with methotrexate
Disease activity score(DAS28) matrix metalloproteinase-3(MMP-3) and matrix metalloproteinase-9(MMP-9), Erythrocyte sedimentation rate C- reactive protein Complete blood count Urine analysis Renal and liver function tests Lipid profile, blood glucose level Serum uric acid Rheumatoid factor (RF IgM, U/L) Anti- cyclic citrullinated peptide . Radiological assessment :Plain radiographs of both hands and feet in the postero-anterior views .
Cardiac assessment :By electrocardiogram ( ECG ) and echocardiography , Carotid artery intima-medial thickness (IMT) will be done by colored doppler ultrasound.
干预措施: Doxycycline Tablets (Drug)
RA patients treated with methotrexate plus doxycycline
Disease activity score(DAS28) Matrix Metalloproteinase-3 (MMP-3) and Matrix Metalloproteinase-9 (MMP-9) Erythrocyte sedimentation rate C- reactive protein Complete blood count Urine analysis Renal and liver function tests Lipid profile, blood glucose level Serum uric acid , Rheumatoid factor (RF IgM(immunoglobulin M), U/L) Anti- cyclic citrullinated peptide. Radiological assessment :Plain radiographs of both hands and feet in the postero-anterior views.
Cardiac assessment :
By electrocardiogram ( ECG ) and echocardiography Carotid artery intima-medial thickness (IMT) will be done by colored doppler ultrasound.
干预措施: Doxycycline Tablets (Drug)
结局指标
主要结局
efficacy of doxycycline
时间窗: 3 months after therapy
percentage of patients achieving remission or low disease activity as assessed by DAS28
safety of doxycycline in combination with MTX
时间窗: at day one of the study and every months till the end of the study
side effects
次要结局
- CIMT as a method for detection of subclinical atherosclerosis in RA patients(1 day)
- MMP-3 and 9 as predictors of cardiovascular affection, disease activity and treatment response(day 1 and 3 months follow up)
研究者
Eman Mohammed Ibrahem Kamel
principal investigator
Assiut University