ISRCTN96372677已完成不适用
Treatment intensification based on disease activity parameters or on cartilage breakdown markers in early rheumatoid arthritis
Vrije University Medical Centre (VUMC) (The Netherlands)0 个研究点目标入组 40 人开始时间: 2005年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
- 性别
- All
入选标准
- •Patients must have:
- •1. Rheumatoid arthritis (American College of Rheumatology [ACR] criteria met cumulatively)
- •2. Requiring treatment: 28-item Disease Activity Score (DAS28) greater than 3.2
- •3. Propensity for radiographic progression: urinary CTX-2 greater than 150 ng/µmol creatinine
排除标准
- •1. Unwillingness to participate in the study and comply with its procedures by signing a written informed consent
- •More chance of harm:
- •2. Contraindication to study drugs:
- •2.1. Previous serious adverse reaction or documented allergy to any of the trial drugs or their constituents
- •2.2. Previous inability to tolerate sulphasalazine (minimum 1 g/d), hydroxychloroquine (minimum 200 mg/d) methotrexate (minimum 7.5 mg/week) or oral prednisolone
- •3. Active infection or those at high risk of infection:
- •3.1. Abnormal chest X-ray or positive tuberculin test suggestive of previous TB that has not been adequately treated
- •3.2. Chronic leg ulcers
- •3.3. Septic arthritis of a native joint within the last 12 months
- •3.4. Previous prosthetic joint sepsis within the last 12 months, indefinitely if prosthesis remains in situ
- •3.5. Bronchiectasis, indwelling urinary catheter and other situation deemed high risk by treating physician
- •4. Malignancy, excluding basal cell carcinoma and malignancies diagnosed and treated more than 10 years previously, in whom there is a high probability of cure in the opinion of the treating physician
- •5. Pregnancy, planned pregnancy or lactation. Women of childbearing age (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed intrauterine device [IUD], condom in combination with spermicide) or be surgically sterilised (e.g., hysterectomy or tubal ligation)
- •6. Current signs or symptoms of severe, progressive, or uncontrolled renal, haematological, hepatic, respiratory, gastrointestinal, endocrine, cardiac, neurological or cerebral disease. Specifically, this includes cardiac failure (New York Heart Association [NYHA] class 3 or 4)
- •7. Screening blood tests at baseline which show haemoglobin less than 8 g/l, total white blood cell count (WBC) less than 3.5 or neutrophils less than 1.5, platelets less than 100. Patients will also be excluded if serum alanine aminotransferase (ALT) or alkaline phosphatase are more than twice the upper limit of normal, or impaired renal function: creatinine greater than 100 mumol/L AND Cockroft creatinine clearance less than 40 ml/min
- •8. Subjects who have used any investigational product within 30 days prior to enrolment
- •9. Aged less than 18 years
- •Less chance of benefit:
- •10. Disease duration greater than 36 months (date of diagnosis by rheumatologist
- •11. Previous treatment of RA with more than two disease modifying anti-rheumatic drugs (DMARDs). Systemic glucocorticoids are counted as DMARDs. Treatment is defined as a cumulative period of 8 weeks or more.
- •Measurement difficulties:
- •12. Insufficient command of local language
- •13. Illiteracy
- •14. Inability to comply with the protocol (opinion of treating physician)
研究者
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