NCT06020144进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind, Positive-controlled, Head-to-Head Monotherapy Study Comparing TLL-018 to Tofacitinib in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
Hangzhou Highlightll Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2023年11月15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
- 进行中（未招募）
- 发起方
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response
研究概览
简要总结
A randomized, double-blind, double-dummy, positive-controlled, phase 3 study to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subjects who had an inadequate response or intolerance to Biologic DMARDs.
详细描述
This is a randomized, double-blind, double-dummy, tofacitinib-parallel-group, phase 3 study to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subjects who had an inadequate response or intolerance to Biologic DMARDs.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65;
- •Meet the diagnostic criteria of rheumatoid arthritis of the American College of Rheumatology/European Alliance against Rheumatism (ACR/EULAR,2010) with duration of at least 3 months;
- •Meet the criteria for active rheumatoid arthritis；
- •Have received at least one kind of bDMARDs for three months or longer and show inadequate response or intolerance to at least one kind of bDMARDs；
- •Meet the ACR (1991) grading criteria of grade I, II or III；
- •Discontinuation of bDMARDs or JAK inhibitors for more than four weeks；
- •To sustain a stable status, oral administration of stable doses of glucocorticoids (≤ prednisone 10 mg/day or equivalent corticosteroids) and stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) are allowed to use, provided that stable doses are maintained for at least one week prior to the study；
- •BMI index is less than 35 kg/m2;
- •Women of Child Bearing Potential (WOCBP) should not be pregnant or breastfeeding and the pregnancy test should be negative before randomization;
- •Subjects (whether male or female) should have adequate barrier contraception during the whole treatment period and at least 90 days after treatment; subjects should avoid the sperm or ovum donation for at least six months after treatment；
- •Subjects understand the informed consent form (ICF), volunteer for the study and sign the ICF;
排除标准
- •With other rheumatic diseases;
- •With other systemic inflammatory diseases;
- •With progressive or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurologic, psychiatric, or cerebral disease;
- •Previous history of severe hematologic diseases;
- •Previous history of malignancy within five years, with exception of cured basal cell carcinoma or cutaneous squamous cell carcinoma or cervical carcinoma in situ.
- •With active infection before randomization;
- •Herpes zoster occurred within 1 year prior to randomization; disseminated or recurrent herpes zoster prior to randomization; disseminated herpes simplex before randomization;
- •Previous history of active tuberculosis (TB) and no evidence of clinical cure or imaging evidence of active TB; or T-spot or PPD positive at screening but have received TB preventive therapy less than one month;
- •HBsAg positive (or HBsAg negative but anti-HBc positive and HBV-DNA quantitative test positive), HCV antibody and HCV-RNA positive, or HIV antibody positive;
- •Previous history of thrombocytopenia, coagulopathy, or platelet dysfunction;
- •Previous history of cardiovascular and cerebrovascular accidents;
- •Previous history of thromboembolism or risk factors;
- •Previous history of gastrointestinal perforation;
- •Temporary usage of NSAIDs within 48 hours prior to the baseline visit;
- •Have received anti-rheumatic herb within 4 weeks before randomization;
- •Have received interferon therapy within 4 weeks before randomization;
- •Have donated blood more than 400 ml or received blood transfusion within 3 months prior to the study;
- •Have received any live vaccine within 2 months before randomization or plan to receive a live vaccine during the study;
- •Have experienced major surgery within 4 weeks before randomization, or expected to receive major surgical treatment after enrollment;
- •Laboratory test results are abnormal and may interfere the study judged by investigators;
- •Use of potent opioids within 4 weeks before the baseline visit;
- •Allergy to ingredients or excipients of tofacitinib or TLL-018;
- •Unable to accomplish evaluation in study;
- •Receiving any study drug within 4 weeks or less than 5 elimination of half-life period) before randomization (whichever is longer);
研究组 & 干预措施
sequence A
Experimental
TLL018 tablets, 2piece,BID
干预措施: TLL-018 (Drug)
sequence B
Active Comparator
Tofacitinib tablets, 1piece,BID
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response
时间窗: Week 24
ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in painful and tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP)at each visit.
次要结局
- Proportion of subjects achieving DAS28-hsCRP <2.6(Week 24)
- Proportion of subjects achieving American College of Rheumatology 20% (ACR20) and 70% (ACR70) Response(Week 24)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count-High-Sensitivity C-reactive Protein (DAS28-hsCRP)(Week 24)
- Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score(Week 24)
- Changes From Baseline in SF-36 Score(Week 24)
- Proportion of subjects achieving DAS28-hsCRP <＝3.2(Week 24)
- Proportion of subjects achieving CDAI <＝10(Week 24)
研究者
研究点 (1)
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