A Randomised, Blinded, Active Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate, (ARABESC)

Fujifilm kyowa Kirin Biologics Co., Ltd,0 个研究点目标入组 100 人开始时间: 2015年7月13日最近更新: 2023年9月4日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

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（—）
性别: All

入选标准

•1.Men or women aged ≥18 years.
•2.RA, diagnosed to revised American College of Rheumatology (ACR) criteria (2010 version) at least 3 months prior to Screening.
•3.Active RA, as confirmed by tender and swollen joint counts ≥6 out of 68/66, respectively, at Screening and at Baseline.
•4.C-reactive protein (CRP) level ≥1.0 mg/dL at Screening.
•5.Taking MTX (oral or parenteral) for at least 3 months prior to Screening and at a stable dose of between 10 and 25 mg/week for at least 8 weeks, with concomitant folic/folinic acid of at least 5 mg/week. Patients can start treatment with folic acid if not already receiving it.
•6.If the patient is currently taking oral steroids (≤10 mg/day prednisone or equivalent) or non-steroidal anti inflammatory drugs (NSAIDs), the patient must be on a stable dose ≥4 weeks prior to Screening and during the study.
•7.Females of childbearing potential must have a negative pregnancy test at Screening, in the 3 weeks prior to study dosing, and every 4 weeks during dosing. Both sexes must be willing to take adequate contraceptive precautions throughout the study period and continuing for at least 5 months after the last dose of study drug. Acceptable methods of contraception in this study are: surgical sterilisation, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, partner’s vasectomy, a double-barrier protection method (condom or diaphragm with spermicide).

排除标准

•1.Prior treatment with adalimumab.
•2.Prior treatment with 2 or more biological disease modifying anti-rheumatic drugs (DMARDs) or protein kinase inhibitors for RA, either as part of clinical management or during a clinical study.
•3.Prior treatment with tumour necrosis factor (TNF) inhibitors with lack of efficacy as per clinical judgment (primary failure). Patients who received 1 TNF inhibitor other than adalimumab at a therapeutic dose and for an adequate period of time, and discontinued it for any reason other than lack of efficacy, will not be excluded.
•4.Prior treatment with cyclophosphamide or other cytotoxic agents.
•5.Treatment with an investigational agent within 12 weeks or 5 half-lives of the drug prior to Screening, whichever is longer.
•6.Immunisation with a live or attenuated vaccine within 4 weeks prior to study drug dosing.
•7.Intra-articular or parenteral steroids within 28 days prior to Screening.
•8.Treatment with any DMARDs, other than MTX, within a period prior to Screening appropriate to the pharmacodynamic profile of the drug concerned, as specified in the protocol.
•9.History of relevant allergy/hypersensitivity to monoclonal antibodies or any of the excipients of FKB327 or Humira.
•10.Presence of autoimmune disease or joint disease other than RA (eg, mixed connective tissue disorder, gout).
•11.ACR functional Class IV.
•12.Major surgery (including joint surgery) within 8 weeks prior to Screening or planned to take place during the study period.
•13.Presence of chronic or acute infection at Screening including positive result for human immunodeficiency virus (HIV) 1 or 2, hepatitis B (HBV), hepatitis C (HCV), and active tuberculosis (TB) or untreated latent TB (eg, positive QuantiFERON test result without any prior history of active or latent TB, and without evidence of active infection) where the patient is not willing to undergo prophylactic treatment, as per protocol.
•14.Acute infection requiring parenteral antibiotics within 4 weeks of study dosing, or oral/topical antibiotics within 2 weeks of study dosing.
•15.Presence of serious, uncontrolled disease of another body system including cardiovascular, neurological, pulmonary, renal and hepatic disease.
•16.Presence of New York Heart Association (NYHA) Class III/IV heart failure.
•17.Presence of any uncontrolled disease for which steroid treatment is regularly required for flares, eg, asthma.
•18.Presence of any malignancy or history of malignancy in the 5 years prior to Screening which has not been curatively treated, with the exception of carcinoma in situ of the cervix or basal cell carcinoma of the skin that has been fully excised.
•19.Patients with aspartate transaminase or alanine transaminase >1.5 × upper limit of normal (ULN), haemoglobin <8 g/dL, absolute neutrophil count<1500/μL, platelets <100,000/μL, and/or creatinine >1.5 × ULN. In case of isolated exclusionary values, the test may be repeated once, at the discretion of the investigator, and the new value used for eligibility.
•20.Patients with demyelinating diseases (eg, multiple sclerosis).
•21.Pregnant or breastfeeding women.
•22.Patients with any condition or circumstances, which, in the opinion of the Investigator, make them unlikely or unable to comply with study procedures and requirements.
•23.Body weight >120 kg.

研究者

发起方

Fujifilm kyowa Kirin Biologics Co., Ltd,

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