NCT00902486已完成2 期
A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement
研究概览
简要总结
This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD
- •For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose
- •For subjects receiving sulfasalazine, they must be treated with Sulfasalazine (SSZ) for at least 6 months and receiving a stable daily dose of no more than 3 grams per day
- •For subjects on methotrexate, they must be treated with methotrexate for at least 6 months, and receiving a stable weekly dose of methotrexate between 7.5 and 25 mg
- •For subjects on leflunomide, they must be treated with leflunomide for at least 6 months, and receiving a stable dose of leflunomide between 10 to 20 mg
- •For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily
- •Active rheumatoid arthritis at the time of screening defined by the following: 6 or more joints tender or painful on motion and 4 or more swollen joints and at least one of the following two: Erythrocyte sedimentation rate (ESR) greater than or equal to 28 mm/hr or C-reactive protein (CRP) greater than or equal to 7 mg/liter
- •Have evidence of lack of risk for tuberculosis
排除标准
- •Current or recent viral, bacterial, fungal, parasitic or mycobacterial infection requiring systemic therapy
- •History of infected joint prosthesis
- •Subjects who have a current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
- •Subjects who have received treatment with the following drugs or drug classes within the specified timeframe: prior treatment with rituximab within 12 months, prior treatment with an oral Janus kinase (JAK) inhibitor, DMARDs or other anti-rheumatic therapies not specified and allowed according to protocol, treatment with any investigational medication within 12 weeks or 5 half-lives (whichever is longer), and treatment with a biologic agent within 12 weeks prior to the first dose of study medication
- •Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring transfusion other than at the time of trauma or surgery, and subjects that meet protocol specified laboratory measures
研究组 & 干预措施
INCB028050 4 mg QD
Experimental
INCB028050 4mg Once daily (QD)
干预措施: INCB028050 (Drug)
INCB028050 7 mg QD
Experimental
INCB028050 7mg QD
干预措施: INCB028050 (Drug)
INCB028050 10 mg QD
Experimental
INCB028050 10mg QD
干预措施: INCB028050 (Drug)
Placebo
Placebo Comparator
Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement
时间窗: Week 12
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Participants With at Least 1 Adverse Event From Baseline Through Week 12
时间窗: From Baseline through week 12
次要结局
- Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6(Week 12 and Week 24)
- Participants With at Least 1 Adverse Event From Week 12 to Week 24(Week 12 to Week 24)
- The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24(From Baseline to Week 24)
- The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24(Week 12 and Week 24)
- Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6(Week 12 and Week 24)
- The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24(Week 12 and Week 24)
- The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24(Week 12 and Week 24)
- Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2(Week 12 and Week 24)
- Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12(Week 12)
- Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24(Week 24)
- Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12(Week 12)
- Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24(Week 24)
- Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24(Week 12 and Week 24)
- Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24(Week 12 and Week 24)
- Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24(Week 12 and Week 24)
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