NL-OMON50283已完成不适用
Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
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
- •- have a diagnosis of rheumatoid arthritis according to the revised 2010
- •EULAR/ACR criteria for classification of RA
- •- have a positive test for the presence of anti-citrullinated protein
- •antibodies (ACPA) in serum as determined by routine clinical assay.
- •- have adequate hematologic function (ANC * 4000 cells/µL, platelet count *
- •150000/µL, and hemoglobin * 10 g/dL (corresponding to 6.2 mmol/L)
- •- have serum creatinine concentrations < 1.5 mg/dl and/or a normal creatinine
- •- be at least 18 years of age
- •- if a female patient is of childbearing potential, agree to: comply with
- •effective contraceptive measures, use adequate contraception since the last
- •menses, use adequate contraception during the study, have a negative pregnancy
- •test within one week of study entry
- •- be willing to receive a booster vaccination against tetanus toxoid three to
- •four weeks prior to randomization
- •- be able and willing to give written informed consent prior to entry in the
排除标准
- •- been previously treated with either abatacept and/or methotrexate or
- •another csDMARD
- •- been previously treated with a kinase inhibitor
- •- been previously treated with rituximab or another B-cell depleting agent
- •- been previously treated with a biological DMARD
- •- received intra-articular or systemic glucocorticoid injections or has
- •required treatment for acute RA flare (not being part of a regular therapeutic
- •regimen) within four weeks prior to randomization or requires narcotic
- •analgesics other than those accepted by the investigator for analgesia (e.g.
- •paracetamol, codeine, tramadol)
- •* been tested negative for anti citrullinated protein antibodies
- •* contraindications for a booster vaccination against tetanus toxoid prior to
- •randomization to the treatment arms; if a patient refuses booster vaccination
- •but has detectable numbers of tetanus toxoid-specific B cells circulating in
- •peripheral blood prior to the baseline visit, the patient can still be allowed
- •to participate in the study at the judgement of the investigator.
- •* evidence of any other major chronic inflammatory disease (i.e. psoriasis,
- •psoriatic arthritis, spondyloarthritis or inflammatory bowel disease)
- •* evidence of poorly controlled diabetes, history of clinically significant
- •pulmonary disease including interstitial lung disease or methotrexate-induced
- •lung disease, poorly controlled asthma or a history of severe life-threatening
- •asthma attacks, history of active tuberculosis, history of latent tuberculosis
- •without adequate medical treatment, liver cirrhosis or fibrosis, significant
- •active infection or any underlying diseases that could predispose the subject
- •to infections
- •* liver function abnormality (total bilirubin * 1.5 x the upper limit of normal
- •range, AST, ALT * 3 x upper limit of normal range)
- •* concurrent treatment with an experimental drug or who has participated in
- •another clinical trial with an investigational drug within 30 days prior to
- •study entry
- •* pre-existing sensory or motor polyneuropathy * Grade 2 according to NCI CTC
- •* past or current history of neoplasms, except for curatively treated
- •non-melanoma skin cancer, adequately treated in situ carcinoma of the cervix or
- •another cancer curatively treated and with no evidence of disease for at least
- •* significant cardiac disease, cardiac arrhythmia (Lown Grade * III),
- •uncontrolled hypertension or recent history of myocardial ischemia
- •* Pregnant or nursing women
研究者
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