NL-OMON50439已完成4 期
A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR
Ronald van Vollenhove/Karolinska Instituut (clinTRID)0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- •1. Subject is >=18 years of age., 2. Subject has a diagnosis of RA as defined by
- •the newly established ACR/EULAR criteria, 2010 (Appendix D). (Patients should
- •also be classified according to the 1987-revised ACR-classification criteria,
- •without this being an inclusion criteria) (Appendix C)., 3. <24 months from
- •arthritis symptom debut (symptom duration will be registered)., 4. Subject must
- •have DAS28 (CRP) > 3.2., 5. >= 2 swollen joints AND >= 2 tender joints., 6.
- •Subject must fulfill one of the following three criteria: RF positive OR ACPA
- •positive OR CRP >=10 mg/L., 7. Female subject is either not of childbearing
- •potential (postmenopausal, surgically sterile etc.), or is of childbearing
- •potential and practicing one of the following methods of birth control
- •throughout the study and for 150 days after study completion:
- •Intrauterine device (IUD)
- •Contraceptives (oral, parenteral, patch) for three months prior to study drug
- •administration)
- •A vasectomized partner
- •8. Female subjects of childbearing potential must have a negative serum
- •pregnancy test at the Screening visit., 9. Subject is judged to be in good
- •general health as determined by the principal investigator based upon the
- •results of medical history, laboratory profile, physical examination, chest
- •X-ray (CXR), and 12-lead electrocardiogram (ECG) performed at Screening., 10.
- •Subjects must be able and willing to provide written informed consent and
- •comply with the requirements of this study protocol., 11. Subjects must be able
- •and willing to self-administer s.c. injections or have a qualified person
- •available to administer s.c. injections.
排除标准
- •1. Subject has been previously treated with disease modifying antirheumatic
- •drugs (DMARDs) for rheumatic diseases., 2. Current active inflammatory joint
- •disease other than RA., 3. Subjects has had a dose of prednisone (or
- •equivalent) >7.5 mg/day or has had a dose change within the preceding 4 weeks.,
- •4. Subject has been treated with intra-articular or parenteral administration
- •of corticosteroids in the preceding 4 weeks. Inhaled corticosteroids for
- •stable medical conditions are allowed., 5. Subject has undergone joint surgery
- •within the preceding two months (at joints to be assessed within the study).,
- •6. Subject has chronic arthritis diagnosed before age 17 years., 7. Subject has
- •a history of an allergic reaction or significant sensitivity to constituents of
- •study drugs., 8. Subject has been treated with any investigational drug within
- •one month prior to screening visit., 9. Active infection of any kind (excluding
- •fungal infections of nail beds), or any major episode of infection requiring
- •hospitalization within 4 weeks of screening., 10. Subject has a poorly
- •controlled medical condition, such as uncontrolled diabetes, unstable heart
- •disease, congestive heart failure, recent cerebrovascular accidents and any
- •other condition which, in the opinion of the investigator, would put the
- •subject at risk by participation in the study., 11. Subject has a history of
- •clinically significant hematologic (e.g., severe anemia, leukopenia,
- •thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis,
- •hepatitis)., 12. Subject has history of neurologic symptoms suggestive of
- •central nervous system (CNS) demyelinating disease and/or diagnosis of central
- •demyelinating disease., 13. Subject has history of cancer or
- •lymphoproliferative disease. Allowable exceptions:
- •a. Successfully treated cutaneous squamous cell or basal cell carcinoma
- •b. Localized carcinoma in situ of the cervix
- •c. Curatively treated malignancy (treatment terminated) > 5 years prior to
- •screening, 14. Subject has a history of listeriosis, histoplasmosis, untreated
- •TB, persistent chronic infections, or recent active infections requiring
- •hospitalization or treatment with intravenous (iv) anti-infectives within 30
- •days or oral anti-infectives within 14 days prior to the BL visit., 15.
- •Subjects will be evaluated for latent TB infection with a PPD or QuantiFERON
- •test and X-ray. Subjects with evidence for latent TB will not be enrolled but
- •first assessed according to local guidelines., 16. Subject is known to have
- •immune deficiency, history of Human Immunodeficiency Virus (HIV) or is
- •otherwise severely immunocompromised., 17. Female subject who is pregnant or
- •breast-feeding or considering becoming pregnant during the study or within 150
- •days after the last dose of study medication., 18. Subject has a history of
- •clinically significant drug or alcohol usage in the last year., 19. Subject has
- •a chronic widespread pain syndrome., 20. Subject is considered by the
- •investigator, for any reason, to be an unsuitable candidate for the study., 21.
- •Subject is unwilling to comply with the study protocol., 22. Screening clinical
- •laboratory analyses show any of the following abnormal laboratory results:
- •a. Aspartate transaminase (AST) or alanine transaminase (ALT) > 1.75 times
- •upper limit of normal (ULN).
- •b. Positive serum
研究者
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