ISRCTN17694963进行中（未招募）4 期
Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification.
niversity of Leeds0 个研究点目标入组 106 人开始时间: 2024年2月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
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
- •1. Subject has a diagnosis of RA as defined by the new ACR/EULAR 2010 classification criteria
- •2. Newly diagnosed (within 12 weeks)
- •3. Active disease at screening (DAS28ESR =3.2 or clinical evidence of synovitis i.e. at least one swollen joint)
- •4. Anti-citrullinated protein antibody (ACPA) positive
- •5. Male & female subjects =18 years old
- •6. DMARD (disease modifying anti-rheumatic drug) naïve
- •7. No use of intra-muscular, intra-articular or oral corticosteroids 4 weeks prior to screening
- •8. All male and female subjects biologically capable of having children must agree to use a reliable method of contraception for the duration of the study and 24 weeks after the end of the study period. Acceptable methods of contraception are surgical sterilisation, oral, implantable or injectable hormonal methods, intrauterine devices or barrier contraceptives.
- •9. Patients must have the capacity and be willing to provide written informed consent and comply with the requirements of the protocol
- •10. Subjects should be deemed to be in good health with respect to clinical examination and screening blood tests, including full blood count (FBC), urea and electrolytes (U&E), and liver functions tests (LFT) – see exclusion criteria for further details.
排除标准
- •1. Use of any additional investigational medications or products within 4 weeks of screening (including prior to screening)
- •2. Use of intra-muscular/intra-articular or oral corticosteroids within 4 weeks prior to screening
- •3. Use of more than one NSAID, or increase in dose of NSAIDs within 24 hours before the screening visit.
- •4. Live vaccine within <4 weeks prior to screening
- •5. Pregnant/lactating women or planning pregnancy within 24 weeks of last protocol treatment
- •6. Planned surgery within the study period (requiring omission of study medication > 4 weeks
- •7. The presence of other comorbidities, which the physician deems as significant to interfere with evaluation (musculoskeletal condition such as osteoarthritis & fibromyalgia)
- •8. Diagnosis of another inflammatory arthritis or connective tissue disease (e.g. psoriatic arthritis or Ankylosing spondylitis, primary Sjögren’s syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis)
- •9. Concomitant severe infection requiring intravenous 4 weeks prior to screening
- •10. Any contraindication to conventional DMARD’s/anti-TNF therapy
- •11. Patients with abnormal liver function at the time of screening or abnormal blood tests as shown by:
- •11.1. Aminotransferase (AST) / alanine aminotransferase (ALT) > 3x upper limit of normal (ULN) OR Bilirubin 50µmol/L
- •11.2. Serum Creatinine > 175 umol/L
- •11.3. eGFR below 30ml/L/min/1.73m²
- •11.4. neutrophils < 2000 x 10^6/L
- •11.5. Platelets < 125 x 10^9/L
- •11.6. Haemoglobin < 90 g/L for males and < 85 g/L for females
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