NL-OMON47583已完成不适用
The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
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
- 年龄范围
- 18 至 99（—）
入选标准
- •RA according to the 1987 or 2010 classification criteria of the American
- •College of Rheumatology (ACR) and the European League Against Rheumatism
- •(EULAR) (Aletaha D 2010); , Inadequate disease control, as evidenced by a
- •28-joint disease activity score (DAS28) of * 2.60.
- •For eligibility, the DAS28 can be calculated with ESR or CRP, and also
- •recalculated from the DAS of 44 joints. A DAS28 may be calculated with clinical
- •and lab assessments obtained no more than 4 weeks before the baseline visit.,
- •age * 65 years.
排除标准
- •Change, stop or start of antirheumatic treatment in the last month prior to
- •eligibility assessment, including methotrexate, sulfasalazine,
- •hydroxychloroquine, leflunomide, azathioprine, intramuscular and oral gold,
- •cyclosporine, biologic agents including anti-TNF, anakinra, abatacept,
- •rituximab, tocilizumab (temporary exclusion);
- •Treatment with systemic GC: oral or parenteral GC with a cumulative
- •prednisolone equivalent dose of 200 mg or higher in the last 3 months;
- •(temporary exclusion)
- •Treatment with any GC (oral, intra-articular, intravenous or intramuscular) in
- •the last 30 days (temporary exclusion);
- •Exposure to investigational therapy in the last three months;
- •Current participation in another clinical trial;
- •Major surgery, donation or loss of approximately 500 ml blood within 4 weeks
- •prior to the screening visit (temporary exclusion)
- •Absolute contraindication to low-dose prednisolone, as determined by the
- •treating physician, such as: uncontrolled chronic infections, diabetes
- •mellitus, hypertension, osteoporosis. When these conditions are under control
- •(e.g. with antiosteoporosis drugs, antihypertensive drugs) these patients can
- •Absolute contraindication to Calcium and/or Vitamin D supplement as determined
- •by the treating physician, such as: hyperparathyroidism (when insufficiently
- •Uncontrolled comorbid conditions, short life span, etc. as determined by the
- •treating physician.
- •Absolute indication to start with oral or intravenous GC, according to the
- •treating physician;
- •Inability to comply with medical instructions or inability to assess major
- •outcomes at 6-monthly visits, in the assessment of the treating physician.
研究者
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