CTIS2024-511442-39-00招募中1 期
Combination of baricitinib and anti-TNF vs. baricitinib alone in patients with rheumatoid arthritis: a randomized placebo-controlled phase-III trial - CRI-RA - CHUBX 2019/56
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 178
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（—）
- 性别
- All
入选标准
- •Age between 18 and 65 years-old, Adult patient with a diagnosis of RA as defined by the ACR/EULAR 2010 criteria for the classification of RA, Patient who presents an inadequate response to at least one bDMARD or tsDMARD for at least 12 weeks prior to study entry at a dose that is considered acceptable to assess clinical response adequately, Patient affected by active RA (DAS28-ESR > 3.2 or sDAI > 11 or cDAI > 10) eligible to receive a bDMARD or tsDMARD according to the French Society of Rheumatology guidelines, Patient treated by prednisone dosage = 10mg per day. The corticosteroids dosage will be decreased to 7,5 mg/day at the beginning of the study (W0), Person affiliated with or beneficiary of the French social security scheme, Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any examination required by the research project)
排除标准
- •Patient previously treated with baricitinib, Patient who has received any parenteral corticosteroid administered by intramuscular or intravenous injection within 4 weeks prior to study entry, or is anticipated to require parenteral injection of corticosteroids during the study, Patient who had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 4 weeks prior to study entry. Joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization cannot be counted in the TJC and SJC for entry or enrollment purpose, Patient with haemoglobin less than 80 g/L, absolute lymphocyte count lower than 0.5×109/L, absolute neutrophil count less than 1×109/L, or platelet count less than 100×109/L; clearance creatinine less than 60 mL/min; total bilirubin more than 1,5 times the upper limit of normal (ULN) at screening, aspartate aminotransferase, or alanine amino-transferase more than 2 times the upper limit of normal (ULN) at screening, Patient with co-administration with OAT3 inhibitors with a strong inhibition potential (such as probenecid)., Patient who has a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data, Patient with an history of Stevens-Johnson syndrome and/or cutaneous vasculitis., Patient with an history of CNS demyelinating disorders and peripheral demyelinating polyneuropathies., Patient with an history of Moderate to severe heart failure (NYHA classes III/IV), Patient with an history of Major Adverse Cardiovascular Events (non-fatal myocardial infarction or non-fatal stroke)., Patient who has a history of VTE (DVT/PE) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE). Prior DVT with PE where events overlapped in time (i.e., with PE considered resulting from DVT) is not considered recurrent DVT/PE for the purpose of this criterion, Patient previously treated by both adalimumab and etanercept. If the patient received previously only one of these two treatments, she/he can be included in the study but with the treatment she/he has not yet received (if she/he is randomized in the experimental COMBI group), Patient who has been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination). Investigators should review the vaccination status of their patients and follow the local guidelines for adult vaccination with nonlive vaccines intended to prevent infectious disease prior to entering patients into the study, Patient with an active cancer, Patient with malignancy or history of malignancy., Patient who has a current or recent (<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection., Patient who is immunocompromised and, in the opinion of the investigator, is at an unacceptable risk for participating in the study., Patient with an history of sepsis or risk of sepsis., Patient with a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)., Patient who had househo
研究者
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