NCT01242917
已完成
2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy
概览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 159
- 主要终点
- Subject incidence of adverse events
概览
简要总结
This is a randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy.
详细描述
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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
- •Male or female subjects, aged 18-75 years inclusive, with functional class I to III rheumatoid arthritis (RA) based on American College of Rheumatology (ACR) criteria for at least 3 months prior to screening; wheel-chair bound subjects or those with irreversible disease will not be eligible;
- •Subjects must have active RA, defined by a minimum of 8 swollen joints and 8 tender/painful joints (based on 66/68 joint count), at screening
- •Serum C-reactive protein (CRP) above 5 mg/L at screening;
- •Must have been on methotrexate (7.5 to 25 mg/week) taken orally, subcutaneously, or intramuscularly for ≥ 16 weeks and on a stable dose for ≥ 8 weeks prior to randomization;
- •If on hydroxychloroquine, must have been on a stable dose for ≥ 16 weeks prior to randomization;
- •If taking non-steroidal anti-inflammatory drugs (NSAIDs), must have been on stable doses for ≥ 2 weeks before randomization;
- •If taking oral corticosteroids, subjects may not take more than 10 mg/day of prednisone or equivalent, and must have been on a stable dose for ≥ 4 weeks before randomization;
- •Willing and able to give written Informed Consent and to comply with the requirements of the study protocol;
- •Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B screen, and the hepatitis C screen;
- •Judged to be otherwise healthy by the Investigator, based on medical history, physical examination (including electrocardiogram \[ECG\]), and clinical laboratory assessments;
排除标准
- •Diagnosed with RA prior to 16 years of age;
- •Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at screening;
- •History within one year prior to randomization of illicit drug use;
- •History of alcohol abuse at any time in the past;
- •Have received sulfasalazine, azathioprine, 6-mercaptopurine, mycophenolate mofetil, tetracycline, cyclosporine, gold, tacrolimus, sirolimus, or other disease modifying anti-rheumatic drug (DMARD) within 8 weeks of randomization;
- •Use of infliximab, adalimumab, abatacept, certolizumab, golimumab, or tocilizumab within 8 weeks of randomization;
- •Use of leflunomide within 6 months of randomization;
- •Use of etanercept or anakinra within 4 weeks of randomization;
- •Use of a B-cell depleting agent such as rituximab or ocrelizumab, or cytotoxic agents, such as cyclophosphamide or chlorambucil, within one year of randomization;
- •Currently taking cytochrome P450 inhibitors including protease inhibitors such as ritonavir, indinavir, nelfinavir, or macrolide antibiotics such as erythromycin, telithromycin, clarithromycin, or azole antifungals such as fluconazole, ketoconazole, itraconazole, or cimetidine, nefazodone, bergamottin (constituent of grapefruit juice), quercetin, aprepitant, or verapamil;
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CCX354-C 100mg twice daily
Experimental
干预措施: CCX354-C (Drug)
CCX354-C 200mg once daily
Experimental
干预措施: CCX-354-C (Drug)
结局指标
主要结局
Subject incidence of adverse events
时间窗: 12 weeks
次要结局
- The change from baseline to week 12 of Disease Activity Score for 28 Joints using C-reactive proteine (DAS28-CRP)(12 weeks)
研究者
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