EUCTR2019-004359-35-NL进行中(未招募)1 期
Induction of Cure in Early Arthritis - I CEA
eiden University Medical Center0 个研究点目标入组 309 人开始时间: 2020年6月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 309
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-=18 year of age and able to give written informed consent (in Dutch or English) and fill out questionnaires in Dutch (or English version, if available)
- •-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
- •-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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 245
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •-Alcohol or substance abuse
- •-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 <40%
- •-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 expression
- •-Increased tendency to develop arterial or venous thrombosis. Assessed by the treating rheumatologist based on family history and medical history of the patient.
研究者
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