EUCTR2014-000109-11-BG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
- 730
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 622
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
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 halflives
- •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
- •_ Presence of serious, uncontrolled disease of another body system
- •including cardiovascular, neurological, pulmonary, renal and hepatic
- •_ Presence of New York Heart Association (NYHA) Class III/IV heart
- •_ 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
相似试验
进行中（未招募）
1 期
Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2014-000109-11-ESFujifilm Kyowa Kirin Biologics Co., Ltd.600
进行中（未招募）
1 期
Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2014-000109-11-CZFujifilm Kyowa Kirin Biologics Co., Ltd.680
进行中（未招募）
1 期
Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2014-000109-11-DEFujifilm Kyowa Kirin Biologics Co., Ltd.730
已完成
不适用
APER-005-15Fujifilm kyowa Kirin Biologics Co., Ltd,100
招募中
4 期
Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & GrowthCTRI/2023/11/060027Vedic Lifesciences Pvt. Ltd