ISRCTN53678960进行中（未招募）2 期
Phase II proof of concept study of baricitinib in individuals who are considered at risk of developing inflammatory arthritis: ExIST
niversity of Leeds0 个研究点目标入组 58 人开始时间: 2022年8月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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. Musculoskeletal symptoms and have tested positive for anti-CCP antibodies (CCP2 test)
- •2. Aged >18 years
- •3. Are able to read, understand, and give written informed consent
- •4. Consents to be randomised to either Baricitinib treatment or continued usual care
- •5. At moderate to high risk of progression to IA as calculated using a prediction model to risk stratify individuals based on the following predictors:
- •5.1. Tenderness of =1 small joint of the hands or feet defined by the physician (1 point)
- •5.2. Early morning stiffness duration =30 min (1 point)
- •5.3. RF and/or anti-CCP Ab concentration >3x upper limit of normal. (2 points)
- •Those with a score of =3 will be eligible to participate.
排除标准
- •1. Previous diagnosis of RA or other form of inflammatory arthritis including, but not limited to SLE, psoriatic arthritis, ankylosing spondylitis, gout or pyrophosphate arthropathy and including current treatment with DMARDs or biological therapy, or a history of DMARD or biological therapy that in the opinion of the investigator constitutes a therapeutic dose
- •2. Clinical synovitis on clinical examination by a rheumatologist
- •3. Palindromic rheumatism
- •4. Individuals who are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to wheelchair
- •5. Presence of concomitant illness likely to require systemic steroid therapy during the study, in the opinion of the investigator
- •6. Co-morbidities requiring chronic treatment with immunosuppressive or immune modulating therapy
- •7. Treatment with an oral, intravenous, intramuscular, intrabursal or intraarticular corticosteroid within 12 weeks prior to randomization
- •8. Have had any major surgery within 12 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator, would pose an unacceptable risk to the screenee
- •9. Scheduled for or anticipating joint replacement surgery
- •10. History of acute allergic reactions to biologic therapies or immunoglobulins
- •11. Have experienced any of the following within 12 weeks of screening: myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure
- •12. Uncontrolled hypertension (=160/95 mmHg), uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia, or any other cardiovascular condition in the past 24 weeks prior to Screening, which, in the opinion of the investigator, would put the screenee at risk by participating in the study
- •13. Have 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 an unacceptable risk when taking investigational product or interfere with the interpretation of data
- •14. Have a history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years
- •15. Have a current or recent (<4 weeks prior to baseline) viral, bacterial, fungal, or parasitic infection that is clinically serious in the opinion of the investigator
- •16. History of disseminated Staphylococcus aureus infection
- •17. History of invasive or opportunistic infection (e.g. listeriosis, pneumocystis or histoplasmosis) or immunodeficiency syndrome
- •18. Have symptomatic herpes simplex or have had symptomatic herpes zoster infection within 12 weeks prior to baseline
- •19. Have a history of disseminated/complicated herpes zoster (for example, multidermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia)
- •20. Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster and atypical mycobacteria)
- •21. Screenees who are =50 years old will be advised to have herpes zoster vaccination. Vaccination must occur >4 weeks prior to baseline. Screenees will be excluded if they are exposed to herpes
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