NCT02141997已完成2 期
A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
AbbVie0 个研究点目标入组 222 人开始时间: 2014年7月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
This study is a Phase 2 randomized, double-blind, double-dummy, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT 122 in subjects with active rheumatoid arthritis (RA) who are inadequately responding to methotrexate (MTX) 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female, 18 years of age or older.
- •Diagnosis of RA based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria (as defined in the definition of terms).
- •Rheumatoid Arthritis (RA) diagnosis at least 3 months from the date of first Screening.
- •Have active RA defined by minimum disease activity criteria:
- •≥ 6 Swollen joints (based on 66 joint counts) at screening and baseline visits.
- •≥ 6 Tender joints (based on 68 joint counts) at screening and baseline visits.
- •hsCRP> ULN OR positive for both Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody levels at screening.
- •Inadequate response to Methotrexate (MTX) treatment defined as oral or parenteral treatment ≥ 3 months with an unchanged mode of application and stable prescribed MTX dose for at least 4 weeks prior to baseline of ≥ 10mg/week and < the upper limit of the applicable approved local label. Subject can also be on stable doses of sulfasalazine and/or hydroxychloroquine, so long as they are also on methotrexate.
排除标准
- •Subject has previous exposure to Humira, other Tumor necrosis factor (TNF) inhibitors or other biological DMARDs.
- •Current treatment with traditional oral Disease modifying antirheumatic drugs (DMARDs) (except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out 5 times the mean terminal elimination half-life of a drug apart from MTX prior to Day
- •Subject could have been exposed to prior Janus kinase (JAK) inhibitors so long as they have been off therapy for 5 half-lives.
- •Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within the 30 days of first dose of study drug.
- •Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of first dose of study drug. Inhaled corticosteroids for stable medical conditions are allowed.
- •Laboratory values of the following at the Screening Visit:
- •Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females,
- •Absolute neutrophil count (ANC) < 1500 mm^3,
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 × the upper limit of normal (ULN) or bilirubin ≥ 3 mg/dL,
- •Serum creatinine > 1.5 × the ULN,
- •Platelets < 100,000 cells/[mm3] (10^9/L),
- •Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
时间窗: Baseline (Day 1) and Week 12
Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).
次要结局
- Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])(Baseline, Weeks 2, 4, 6, 8, and 12)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12(Baseline (Day 1) and Week 12)
- Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12(Week 12)
- Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12(Week 12)
- Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12(Week 12)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12(Baseline (Day 1) and Week 12)
- Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12(Week 12)
研究者
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