NCT05849727终止2 期
Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of TQH3821 Tablets in Patients With Treated Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 195
- 试验地点
- 34
- 主要终点
- American College of Rheumatology 20 (ACR20) improvement
研究概览
简要总结
To evaluate the efficacy and safety of TQH3821 in treated patients with moderate-to-severe active rheumatoid arthritis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in this study and sign informed consent;
- •Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
- •The diagnosis meets the rheumatoid arthritis (RA) classification criteria jointly established by the American College of Rheumatology (ACR) and the European Alliance against Rheumatism (EULAR) in 2010, for at least 3 months ;
- •Moderate to severe active RA was defined by the following criteria: joint swelling ≥6 (based on 66 joints), joint tenderness ≥6 (based on 68 joints), Disease activity score 28-C-reactive protein (DAS28-CRP) ≥3.2, and CRP>10mg/L or erythrocyte sedimentation rate (ESR) >28mm/h;
- •At least 12 weeks of treatment with methotrexate (dose 7.5 to 25 mg/ week) and stable dose (7.5 to 25 mg/ week) ≥4 weeks prior to initial administration of the study drug (oral stable dose methotrexate will be continued as background therapy during the trial);
- •The subjects can attend the study visit on time and complete the visit;
排除标准
- •8 weeks before baseline examination, subjects underwent joint surgery or received intraarticular glucocorticoid therapy at the joint sites evaluated in this study;
- •Patients with rheumatoid arthritis with joint functional activity grade Ⅳ or confined to a wheelchair or bed;
- •Current or previous inflammatory joint diseases other than RA and other autoimmune venereal diseases;
- •Patients with lung diseases deemed unsuitable for the study by the investigator;
- •Cardiovascular and cerebrovascular abnormalities;
- •Abnormal thyroid function;
- •Subjects with a history or suspected demyelinating disease of the central nervous system;
- •Have any type of active malignant tumor or have a history of malignant tumor;
- •Presence of active Mycobacterium tuberculosis (TB) infection or latent TB infection without appropriate treatment;
- •Have any acute or chronic active infectious disease;
- •There are serious poorly controlled diseases;
- •People with active hepatitis, or hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive + hepatitis B virus (HBV) DNA positive, or hepatitis C virus (HCV) antibody-positive;
- •History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening, and positive antibodies to treponema pallidum during screening;
- •Subjects who had suffered a severe trauma, fracture, or surgical procedure within 8 weeks prior to screening, or who were expected to require major surgical procedures during the study period;
- •Female subjects who are pregnant or lactating;
- •Those who received live attenuated vaccine within 28 days before the start of treatment, inactivated vaccine within 7 days, or planned vaccination during the study period;
- •The subject has any medical condition that may affect oral drug absorption, gastrectomy or gastrointestinal disease of clinical significance.
研究组 & 干预措施
TQH3821 tablets 200 mg
Experimental
Oral administration of TQH3821 tablets 200 mg, twice a day for 24 weeks.
干预措施: TQH3821 tablets 200 mg (Drug)
TQH3821 tablets matching placebo
Placebo Comparator
The placebo group was taken orally until the end of week 12. At the end of week 12, the placebo group was switched to the oral administration of TQH3821 tablets 200 mg until the end of week 24.
干预措施: TQH3821 tablets 200 mg (Drug)
TQH3821 tablets matching placebo
Placebo Comparator
The placebo group was taken orally until the end of week 12. At the end of week 12, the placebo group was switched to the oral administration of TQH3821 tablets 200 mg until the end of week 24.
干预措施: TQH3821 tablets matching placebo (Drug)
结局指标
主要结局
American College of Rheumatology 20 (ACR20) improvement
时间窗: Evaluated at week 12.
Proportion of patients with ACR20 at week 12.
次要结局
- American College of Rheumatology 50 (ACR50) improvement(Evaluated at week 4, 8, 12, 18, and 24.)
- C-reactive protein (CRP)(Evaluated at week 4, 8, 12, 18, and 24.)
- Erythrocyte sedimentation rate (ESR)(Evaluated at week 4, 8, 12, 18, and 24.)
- 66 joint swelling counts (SJC)(Evaluated at week 4, 8, 12, 18, and 24.)
- 68 joint tenderness counts (TJC)(Evaluated at week 4, 8, 12, 18, and 24.)
- Health Assessment questionnaire-Disability Index (HAQ-DI)(Evaluated at week 4, 8, 12, 18, and 24.)
- Disease activity score 28-C-reactive protein (DAS28-CRP)(Evaluated at week 4, 8, 12, 18, and 24.)
- Patient's visual analogue score (PVAS)(Evaluated at week 4, 8, 12, 18, and 24.)
- Patient's global assessment (PtGA)(Evaluated at week 4, 8, 12, 18, and 24.)
- Physician's global assessment (PhGA)(Evaluated at week 4, 8, 12, 18, and 24.)
- American College of Rheumatology 20 (ACR20) improvement(Evaluated at week 4, 8, 18, and 24.)
- Incidence of adverse events(Baseline up to 28 weeks.)
- Severity of adverse events(Baseline up to 28 weeks.)
研究者
研究点 (34)
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