EUCTR2018-003351-37-GR进行中（未招募）1 期
A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,600
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
- •[1] Have a diagnosis of adult onset RA as defined by the 2010 Rheumatoid arthritis classification criteria: An American College of Rheumatology/European League against Rheumatism collaborative initiative (Aletaha et al. 2010)
- •[2] If RA symptom onset is <6 months, are rheumatoid factor or anticitrullinated antibody positive as assessed by the central laboratory during screening
- •[3] Have moderately to severely active RA defined as the presence of at least 3/28 tender joints and at least 3/28 swollen joints assessed at Visits 1 and 2. Joints with significant surgical treatment or injury cannot be counted towards the minimum number of tender and swollen joints for enrollment purposes
- •[4] Have had an inadequate response or intolerance to at least 1 DMARD (synthetic or biologic)
- •[5] Are male or female patients who are at least 18 years of age
- •[6] Have at least 1 of the following 4 characteristics:
- •a. Documented evidence of a VTE prior to this study
- •b. Age =60 years
- •c. BMI =30 kg/m2
- •d. Age 50 to <60 years AND BMI 25 to <30 kg/m2
- •[7] Nonpregnant, non breastfeeding female patient of childbearing potential:
- •a. Patients who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same sex relationship without sexual relationships with the opposite sex during the entirety of the study and for 1 week after the last dose of baricitinib, 3 weeks after the last dose of etanercept, and 5 months after the last dose of adalimumab.
- •Total abstinence is defined as refraining from intercourse during the entirety of the study and for 1 week after the last dose of baricitinib, 3 weeks after the last dose of etanercept, and 5 months after the last dose of adalimumab. Periodic abstinence such as calendar, ovulation, symptothermal, postovulation methods, and withdrawal are not acceptable methods of contraception.
- •b. Otherwise, female patients must agree to use 1 highly effective method of contraception (defined as less than 1% failure rate per year when used consistently and correctly), such as combination oral contraceptives, implanted contraceptives, or intrauterine devices, for the entirety of the study and for 1 week after the last dose of baricitinib, 3 weeks after the last dose of etanercept, and 5 months after the last dose of adalimumab.
- •Female patients of non-childbearing potential may participate without requirements for contraception. This includes female patients who are
- •a. Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or
- •b. Postmenopausal – defined as either
- •i. A woman at least 50 years of age with an intact uterus, not on hormone therapy, who has had either
- •1. Cessation of menses for at least 1 year, or
- •2. At least 6 months of spontaneous amenorrhea with a follicle stimulating hormone >40 mIU/mL; or
- •ii. A woman 56 years of age or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; or
- •iii. A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy.
- •[8] Must read and understand the informed consent and provide written informed consent
- •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 2080
- •F.1.3 Elderly (>=
排除标准
- •[1] Have any contraindications or hypersensitivity to:
- •a TNF inhibitor
- •baricitinib
- •the active substance, or
- •any of the excipients listed in the SmPC Section 6.1
- •[2] Are pregnant or breastfeeding. Prior to initiation of treatment, female patients of childbearing potential must have a negative serum pregnancy test at the central laboratory during screening and a negative urine pregnancy test at Visit 2
- •[3] Have a history of VTE within 12 weeks prior to randomization or have a history of recurrent (>1) VTE
- •[4] Have active primary or recurrent malignant disease or have been in remission from clinically significant malignancy for <5 years prior to randomization
- •[5] Have active herpes zoster
- •[6] Have a clinically serious infection or have any other active or recent infection that in the opinion of the investigator would pose an unacceptable risk to the patient if participating in the study. This is also applicable to patients with evidence of HIV infection and/or who are positive for anti-HIV antibodies
- •[7] Have a history or presence of any illness that in the opinion of the investigator could pose an unacceptable risk to the patient if participating in the study or interfere with the interpretation of data
- •[8] Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB
- •[9] Have evidence of active TB or untreated / inadequately / inappropriately treated for latent TB
- •[10] Have received more than 1 prior TNF inhibitor that was:
- •a. Discontinued for inadequate response for RA or
- •b. Discontinued for intolerance (AE) when used for any indication
- •[11] Have been treated with a bDMARD within 4 weeks of randomization (within 24 weeks of randomization for rituximab)
- •[12] Are being treated with more than 2 cDMARDs
- •[13] Have been treated with a JAK inhibitor
- •[14] Have received a live vaccine within 4 weeks of randomization or are expected to need/receive a live vaccine during the course of the study. Investigators should update immunizations (including, where applicable, herpes zoster) in agreement with current immunization guidelines prior to randomization
- •[15] Are being treated with a strong organic anion transporter 3 (OAT3) inhibitor, such as probenecid, that cannot be discontinued for the duration of the study
- •[16] Are being treated with an anticoagulant.Antiplatelet agents such as aspirin, clopidogrel, and prasugrel are not considered anticoagulants for the purpose of this study
- •[17] Have been previously enrolled in any baricitinib study
- •[18] Have any of the following:
- •a. ALT or AST >2 x the upper limit of normal (ULN)
- •b. alkaline phosphatase (ALP) =2 x ULN
- •c. total bilirubin level (TBL) =1.5 x ULN
- •d. hemoglobin <8 g/dL (80.0 g/L)
- •e. neutropenia (absolute neutrophil count <1000 cells/µL) (<1.00 x 103/µL or <1.00 GI/L)
- •f. lymphopenia (lymphocyte count <500 cells/µL) (<0.50 x 103/µL or <0.50 GI/L)
- •g. eGFR (Modification of Diet in Renal Disease) <30 mL/min/1.73 m2
- •[19] Have any screening laboratory test values outside the reference range for the population that in the opinion of the investigator pose an unacceptable risk for the patient’s participation in the study
- •[20] Have hepatitis B virus (HBV) infection defined as:
- •a. positive for hepatitis B surface antigen (HBsAg), or
- •b. positive for HBV DNA
- •[21] Have hepatitis C virus (HCV) infection defined as:
- •a. positive for hepatitis C antibody, and
- •b. positive for HCV ribonucleic acid [RNA]
- •[22] Are currently
研究者
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