EUCTR2014-000109-11-ES进行中（未招募）1 期
A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate.
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
- 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
- •_ Men or women aged ? 18 years.
- •_ RA, diagnosed to revised American College of Rheumatology (ACR) criteria (2010 version) at least 3 months prior to Screening.
- •_ Active RA, as confirmed by tender and swollen joint counts ?6 out of 68/66, respectively, at Screening and at Baseline.
- •_ C-reactive protein (CRP) level ?1.0 mg/dL at Screening.
- •_ 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.
- •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 510
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Patients will be excluded from the study if any of the following exclusion criteria are met (list not comprehensive):
- •_ Prior treatment with adalimumab.
- •_ Prior treatment with 2 or more biological disease modifying anti-rheumatic drugs (DMARDs) or protein kinase inhibitors for RA.
- •_ Prior treatment with tumour necrosis factor (TNF) inhibitors with lack of efficacy.
- •_ Prior treatment with cyclophosphamide or other cytotoxic agents.
- •_ Treatment with an investigational agent within 12 weeks or 5 half-lives of the drug.
- •_ Immunisation with a live or attenuated vaccine within 4 weeks prior to study drug dosing.
- •_ Intra-articular or parenteral steroids within 28 days prior to Screening.
- •_ Treatment with any DMARDs, other than MTX.
- •_ History of relevant allergy/hypersensitivity to monoclonal antibodies or any of the excipients of FKB327 or Humira.
- •_ Presence of autoimmune disease or joint disease other than RA.
- •_ ACR functional Class IV.
- •_ Major surgery within 8 weeks prior to Screening or planned to take place during the study period.
- •_ 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.
- •_ Acute infection requiring parenteral antibiotics within 4 weeks of study dosing.
- •_ Presence of serious, uncontrolled disease of another body system including cardiovascular, neurological, pulmonary, renal and hepatic disease.
- •_ Presence of New York Heart Association (NYHA) Class III/IV heart failure.
- •_ Presence of any uncontrolled disease for which steroid treatment is regularly required for flares.
- •_ Presence of any malignancy or history of malignancy in the 5 years.
- •_ Patients with aspartate transaminase or alanine transaminase >1.5 × ULN, haemoglobin <8 g/dL, absolute neutrophil count<1500/?L, platelets <100,000/?L, and/or creatinine >1.5 × ULN.
- •_ Patients with demyelinating diseases.
- •_ Pregnant or breastfeeding women.
- •_ 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.
- •_ Body weight >120 kg.
研究者
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