A Multicenter, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG-760564 in Adult Patients With RA Receiving Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks
研究概览
简要总结
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
详细描述
The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study.
The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept.
After the washout period, the patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit.
The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
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
- Double (Participant, Investigator)
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
- •Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
- •Disease duration of at least 6 months
- •Must be treated with Methotrexate for at least 24 weeks
- •At least 6 swollen joints and 6 tender joints
- •Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)
- •Women of childbearing age and all males must use acceptable method of birth control
排除标准
- •Tuberculosis
- •Malignancies
- •Abnormal electrocardiograms as described in the protocol
- •Current infection or recurrent infections or immunodeficiency
- •Liver diseases and abnormalities in liver function tests as described in the protocol
- •Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA;
- •History of demyelization diseases
- •Any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol
研究组 & 干预措施
Placebo
Placebo, oral dose, BID
干预措施: Placebo dose (Drug)
25 mg PG-760564
25 mg BID, of oral PG-760564
干预措施: PG-760564 (Drug)
100 mg PG-760564
100 mg BID, of oral PG-760564
干预措施: PG-760564 (Drug)
结局指标
主要结局
Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks
时间窗: 12 weeks
percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
次要结局
未报告次要终点