NL-OMON49359招募中4 期
PeRsonalIzed MEdicine in Rheumatoid Arthritis (PRIMERA trial): a multicenter, single-blinded, randomized controlled trial comparing usual care with a tailor-made approach - PRIMERA
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
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
- •- Newly diagnosed, DMARD-naive RA patients, according to 2010 criteria
- •- Age >=18 years
排除标准
- •1. Current or previous treatment of arthritis with DMARDs
- •2. Glucocorticoids (GCs) in the 3 months prior to randomization
- •3. (Relative) contraindications for study medication:
- •a. Evidence of ongoing infectious or malignant process obtained within 3 months
- •prior to screening and evaluated by a qualified health care professional.
- •b. Pregnant or nursing (lactating) women.
- •c. Female participants of child bearing potential and male participants whose
- •partner is of child bearing potential who are not willing to ensure that they
- •or their partner use effective contraception during the trial and for 3 months
- •thereafter as in standard practice.
- •d. History of clinically significant liver disease or liver injury as indicated
- •by abnormal liver function tests (LFT) such as aspartate aminotransferase/serum
- •glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ serum
- •glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, or serum
- •bilirubin. The Investigator should be guided by the following criteria: Any
- •single parameter may not exceed 2 x upper limit of normal (ULN). A single
- •parameter elevated up to and including 2 x ULN should be re-checked once more
- •as soon as possible, and in all cases, at least prior to
- •enrollment/randomization, to rule out laboratory error.
- •e. History of renal trauma, glomerulonephritis, or subjects with one kidney
- •only, or a glomerular filtration rate (GFR) < 30 ml/min.
- •f. Other underlying metabolic, hematologic, renal, hepatic, pulmonary,
- •neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which
- •in the opinion of the Investigator immunocompromises the patient and/or places
- •the patient at unacceptable risk for participation in an immunomodulatory
- •4. Unable to understand, speak and write in Dutch.
研究者
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