NCT03830203已完成3 期
A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Bio-Thera Solutions1 个研究点 分布在 1 个国家目标入组 621 人开始时间: 2018年12月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 621
- 试验地点
- 1
- 主要终点
- Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
研究概览
简要总结
This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group, active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared with RoActemra in subjects with RA that is inadequately controlled by MTX.
The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (TP1), a 24 week secondary treatment period (TP2), and an extra 4-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 years of age or older who fulfil the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 revised classification criteria for RA diagnosis for at least 6 months before screening, based on the medical history record.
- •Subject presents with active RA, as defined by:
- •≥ 6 out of 68 tender joints (at screening and randomization) AND
- •≥ 6 out of 66 swollen joints (at screening and randomization) AND
- •Serum C-reactive protein (CRP) > upper limit of normal (ULN) value or erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening.
- •Subjects are eligible if they have received not more than 2 biological agents other than interleukin-6 inhibitors or targeted synthetic DMARDs (eg, tofacitinib) in total for RA treatment.
- •Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must be willing to take reliable contraceptive precautions throughout the study period and continuing for at least 3 months after the last dose of study drug. Reliable methods of contraception include: intrauterine device, hormonal contraceptives (eg, oral, patch, or injectable), male vasectomy (if vasectomy was medically confirmed), a barrier protection method (eg, condom or diaphragm) in association with spermicide cream, foam, or gel. Abstinence from heterosexual intercourses is accepted when this is the usual lifestyle of the subject and must be continued for at least 3 months after the last dose of study drug. A female subject is considered not of child-bearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy).
- •If female of childbearing potential, subject should have a negative pregnancy test result at screening and baseline visit.
- •Subjects must be willing to provide written consent and to comply with the requirements of the study protocol.
排除标准
- •Has RA of ACR functional class IV or is wheelchair/bed bound.
- •Known hypersensitivity to tocilizumab or to study treatment excipients.
- •Subject has received any cell-depleting therapy (eg, rituximab) ≤ 12 months prior to randomization.
- •Subject has been treated with an investigational drug other than those prohibited or device ≤ 8 weeks or 5 half-lives of the drug (whichever is longer) prior to randomization.
- •Subject has undergone joint surgery ≤ 12 weeks prior to randomization (on any joint to be assessed during the study) or has any surgery planned during the study.
- •Evidence of malignancy, lung infection, or abnormalities suggestive of active tuberculosis (TB) on chest radiography performed within 12 weeks prior to the Screening Visit or during the screening period.
- •Any recurrent bacterial, fungal, or viral infection that based on the investigator´s clinical assessment makes the subject unsuitable for the study, including recurrent/disseminated herpes zoster.
- •Current or history of diverticulitis, complications of diverticulitis, history of diverticulosis requiring antibiotic treatment, current or history of chronic ulcerative lower gastrointestinal tract diseases or any other lower gastrointestinal condition that may predispose to perforation.
- •Any history of malignancy or lymphoproliferative disease at any time, except curative treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix.
- •Have a transplanted organ/tissue or stem cell transplantation.
- •Subject has an underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal condition, which in the opinion of the investigator places the subject at unacceptable risk.
- •Subject has a history of demyelinating diseases (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
- •Subject has received any live or attenuated vaccine ≤ 4 weeks prior to randomization or plans to receive it during the study including the safety follow up period.
- •Subject has a history of clinically significant drug or alcohol abuse in the last 12 months as judged by the investigator.
- •Pregnant or nursing (lactating) women.
- •Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
研究组 & 干预措施
BAT1806
Experimental
BAT1806 injection: 8 mg/kg, intravenous infusion by 60 min
干预措施: BAT1806 (Drug)
Actemra(EU-licensed)
Active Comparator
Actemra(EU-licensed): 8 mg/kg, intravenous infusion by 60 min
干预措施: Actemra(EU-licensed) (Drug)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
时间窗: 6 months
ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant (ESR).
次要结局
- Change From Baseline in DAS28(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular DegenerationNeovascular(Wet) Age Related Macular DegenerationNCT04857177Chong Kun Dang Pharmaceutical312
已完成
3 期
Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute UrticariaAcute UrticariaNCT02935699JDP Therapeutics, Inc.262
已完成
3 期
Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive EsophagitisErosive Esophagitis (EE)NCT03615677Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.261
已完成
3 期
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic ChemotherapyChemotherapy-induced Nausea and VomitingNCT01500226Tesaro, Inc.1,369
已完成
3 期
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic ChemotherapyChemotherapy-induced Nausea and VomitingNCT01499849Tesaro, Inc.532