NL-OMON54053招募中3 期
Induction of Cure in Early Arthritis. A single blind randomized clinical trial. - I CEA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 111
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 64（—）
入选标准
- •Inclusion criteria
- •- >=18 and < 65 years of age and able to give written informed consent (in Dutch
- •or English) and fill out questionnaires in Dutch (or English version, if
- •- Clinical early unclassified arthritis of at least one joint, not fulfilling
- •ACR/EULAR 2010 criteria for rheumatoid arthritis
- •- Symptom duration of arthritis <1 year
- •- Other diagnoses causing the arthritis rejected (including infection,
- •(pseudo-)gout, psoriatic arthritis, non-rheumatoid auto-immune disease,
- •paraneoplastic arthritis)
- •- DAS>1.6 and at least two swollen and painful joints
- •- No wish to become pregnant, breastfeed or father a child during the study
- •- No contraindications to treatment with NSAIDs, MTX (or sulfasalazine or
- •leflunomide as alternative) and baricitinib as required in the study
排除标准
- •Exclusion criteria
- •- Alcohol or substance abuse, current smoking or a long history of smoking
- •- Immuno-compromised state either based on co-morbidity or co-medication
- •- Leucopenia <3*10^9/l, and/or neutropenia <1*10^9/l
- •- Hemoglobin <5 mmol/l
- •- Increased liver enzymes > 3x upper limit of normal
- •- Renal insufficiency with estimated creatinine clearance <60%
- •- Interstitial lung disease as seen on X-thorax
- •- Maintenance treatment with corticosteroids exceeding prednisone 10 mg daily
- •or equivalent
- •- Active or ongoing chronic infection, (recurrent) serious infection(s) in past
- •4 months, latent TB who refuse anti-tuberculous treatment, hepatitis B with
- •positive DNA viral load or hepatitis C with positive RNA viral load, patients
- •with anti-HB2 and anti-HBc antibodies who refuse monitoring of hepatitis B DNA
- •-increased tendency to develop arterial or venous thrombosis or increased risk
- •for major cardiovascular events as assessed by the treating rheumatologist.
- •Risk of arterial thrombosis is based on calculation of the cardiovascular
- •SCORE, which includes cholesterol ratio, systolic blood pressure, age, gender,
- •diabetes, history of cardiovascular disease and smoking status. Only patients
- •in the green category of the NHG CVRM risk table will be included
- •- Increased risk of malignancy; this includes patients with a history of a
- •malignancy (except basal cell carcinoma, and squamous cell carcinoma, and
- •cervical carcinoma in situ and other malignancies that have been treated
- •curatively >10 years ago, for instance types of thyroid cancer) and patients
- •with syndrome which increase cancer risk (e.g. BRCA/HNPCC/LYNCH).
研究者
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