A Phase 2a, Randomized, Investigator and Patient-blind, Sponsor-unblinded, Parallel Group, Placebo-controlled Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Primary Outcome Measure is the Determination of the Safety and Tolerability of ATI-450 Plus Methotrexate in Patients With Moderate to Severe Rheumatoid Arthritis: Adverse Events (AEs)
研究概览
简要总结
This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA.
详细描述
This is a Phase 2, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA with inadequate response to methotrexate. All subjects will be required to complete a safety follow up visit 30 days post last study medication administration.
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)
盲法说明
The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.
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
- •Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
- •DAS28-CRP ≥3.2 defined as moderate to high disease activity.
- •Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints.
- •hsCRP ≥5 mg/L at screening.
- •Patients must have definitive intra-articular synovitis or osteitis defined as a score of 1 or greater on a Hand-Wrist MRI as assessed by central imaging reader (using RAMRIS).
- •On a stable MTX dose and a stable dose of folic or folinic acid prior to the screening visit.
排除标准
- •Patient has a current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
- •Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results.
- •History or evidence of active or latent tuberculosis.
- •Active infection requiring treatment with antibiotics.
- •Blood pressure levels (in supine position after at least 5 minutes rest): <90 mmHg or >140 mmHg for systolic blood pressure or <40 mmHg or >90 mmHg for diastolic blood pressure.
- •Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit.
- •Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of the screening visit.
- •Patients with history of stroke.
- •Any joint procedure in the past 90 days prior to screening.
研究组 & 干预措施
Placebo plus Methotrexate
Placebo oral tablet BID with a stable weekly dose of Methotrexate
干预措施: Placebo oral tablet (Drug)
ATI-450 plus Methotrexate
ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate
干预措施: ATI-450 (Drug)
ATI-450 plus Methotrexate
ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate
干预措施: Methotrexate (Drug)
Placebo plus Methotrexate
Placebo oral tablet BID with a stable weekly dose of Methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
The Primary Outcome Measure is the Determination of the Safety and Tolerability of ATI-450 Plus Methotrexate in Patients With Moderate to Severe Rheumatoid Arthritis: Adverse Events (AEs)
时间窗: Baseline through Day 114
Safety and tolerability reported as Adverse Events (AEs). AEs will be coded with the Medical Dictionary for Regulatory Activities (MedDRA) version 23.0. AEs will be presented by system organ class and preferred term in frequency tables.
次要结局
- Number and Percent of Patients Achieving ACR 70(Baseline through Day 114)
- Percent Change in (hsCRP) Levels Over Time(Baseline through Day 114)
- Change From Baseline in Disease Activity Score(Baseline through Day 114)
- Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time(Baseline through Day 114)
- Change From Baseline in RAMRIS Hand-Wrist Assessments (Osteitis Average)(Baseline through Day 84)
- Change From Baseline in RAMRIS Hand-Wrist Assessments (Synovitis Average)(Baseline through Day 84)
- Assessment of ATI-450 Concentration (ng/mL)(Day 1 through Day Day 84)
- Number and Percent of Patients Achieving ACR 20(Baseline through Day 114)
- Number and Percent of Patients Achieving ACR 50(Baseline through Day 114)