EUCTR2014-000109-11-CZ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. - ARABESC
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
- 680
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 =6 tender and =6 swollen joint counts out of 68/66, respectively, at Screening and at Baseline.
- •_ C-reactive protein (CRP) level =10 mg/L 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 at Screening 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 580
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
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 more than 1 biologic or 1 protein kinase inhibitor DMARD for RA.
- •_ Prior treatment with TNF inhibitors for RA with lack of efficacy.
- •_ Prior treatment with cyclophosphamide.
- •_ 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, or history of clinically significant contact allergy/hypersensitivity to latex or rubber.
- •_ Presence of active autoimmune disease or joint disease other than RA (eg, mixed connective tissue disorder, gout) which may confound efficacy assessments such as joint count evaluations or CRP/erythrocyte sedimentation rate (ESR).
- •_ 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 or requiring oral/topical antibiotics within 2 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 demyelinating diseases.
- •_ Pregnant or breastfeeding women.
- •_ Patients with any condition or circumstances, which, in the opinion of the Investigator, make them unsuitable for the study, unlikely or unable to comply with study procedures and requirements.
- •_ Body weight >120 kg.
- •_ Prior or current treatment with an agent which might confound efficacy or safety evaluation in this study, eg, RANKL inhibitors for osteoporosis, immunomodulators for asthma within 5 half-lives of the drug concerned prior to the first dose of study treatment.
研究者
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