ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Alone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving ACR20 at Week 12
研究概览
简要总结
ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA) who have had an Inadequate Response to MTX Alone
详细描述
This is a Phase 2b, Randomized, Multicenter, Double-blind, Parallel Group, Placebo Controlled, Dose Ranging Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA) who have had an Inadequate Response to MTX Alone
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and be willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient ICF prior to administration of any study-related procedures.
- •Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
- •Have active moderate to severe RA at Screening.
- •A minimum of 12 weeks on MTX with a stable MTX dose.
排除标准
- •Current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
- •Uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results (eg, previous malignancy, recurrent infection, previous venous thromboembolism).
- •Patient has experience with > 2 biologics, > 1 JAK inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
- •Currently receiving corticosteroids at doses > 10 mg/day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening.
研究组 & 干预措施
ATI-450 20 mg BID plus Methotrexate
ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks
干预措施: Methotrexate (Drug)
ATI-450 20 mg BID plus Methotrexate
ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks
干预措施: ATI-450 20 mg oral tablet BID (Drug)
ATI-450 50 mg BID plus Methotrexate
ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
干预措施: ATI-450 50 mg oral tablet BID (Drug)
ATI-450 50 mg BID plus Methotrexate
ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
干预措施: Methotrexate (Drug)
Placebo plus Methotrexate
Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
干预措施: Placebo oral tablet (Drug)
Placebo plus Methotrexate
Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
干预措施: Methotrexate (Drug)
结局指标
主要结局
Proportion of patients achieving ACR20 at Week 12
时间窗: Baseline to Week 12
次要结局
- Proportion of patients achieving DAS28-CRP remission (score < 2.6) over time(Up to 12 Weeks)
- Proportion of patients achieving ACR50/70 at Week 12(Baseline to Week 12)
- Proportion of patients achieving ACR20/50/70 over time(Up to 12 Weeks)
- Mean change from baseline in DAS28-CRP over time(Up to 12 Weeks)
- Proportion of patients achieving DAS28-CRP low disease activity (score ≤ 3.2) over time(Up to 12 Weeks)
- Proportion of patients achieving CDAI remission (score ≤ 2.8) over time(Up to 12 Weeks)
- Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) score over time(Up to 12 Weeks)
- Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities(Baseline to Week 12)
- Mean change from baseline in CDAI over time(Up to 12 Weeks)
- Percent change from baseline in hsCRP level over time(Up to 30 days after 12 weeks of treatment)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) score over time(Up to 12 Weeks)
- Short Form Health Survey version-2.0 (SF-36v2) score over time(Up to 12 Weeks)
- Trough ATI-450 and metabolite (CDD-2164) concentrations at clinic visits (trough and 2-hour post dose will be collected).(Study Days 1, 8, and 85)