NCT02066389已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 With Background Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone
AbbVie63 个研究点 分布在 13 个国家目标入组 300 人开始时间: 2014年3月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 63
- 主要终点
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
The primary objective of the study was to compare the safety and efficacy of multiple doses of upadacitinib versus placebo in adults with moderately to severely active rheumatoid arthritis (RA) on stable background methotrexate therapy who had not shown an adequate response to methotrexate alone.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with RA based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 ACR/European League against Rheumatism (EULAR) criteria for ≥ 3 months.
- •Have active RA as defined by the following 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.
- •high-sensitivity C-reactive protein (hsCRP) > upper limit of normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (CCP) at Screening.
- •Subjects must have been receiving oral or parenteral methotrexate therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to Baseline Visit. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to Baseline Visit. Subjects should continue with their stable doses of methotrexate and folic acid throughout the study.
- •Except for MTX, subjects must have discontinued all oral disease-modifying anti-rheumatic drugs (DMARDs) prior to Baseline Visit as specified below or for at least five times the mean terminal elimination half-life of a drug, whichever is longer:
- •≥ 4 weeks prior to Baseline Visit for minocycline, penicillamine, sulfasalazine, hydroxychloroquine, chloroquine, azathioprine, gold formulations, cyclophosphamide
- •≥ 8 weeks prior to Baseline Visit for leflunomide if no elimination procedure was followed, or adhere to a washout procedure (i.e., 11 days washout with colestyramine, or 30 days washout with activated charcoal)
- •Subject has a negative tuberculosis (TB) Screening Assessment. If the subject has evidence of a latent TB infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis or have documented completion of a full course of TB prophylaxis, prior to Baseline Visit.
- •Subjects can be taking non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen, oral corticosteroids (equivalent to prednisone ≤ 10 mg), or inhaled corticosteroids at a stable dose for at least 4 weeks prior to Baseline Visit for stable medical conditions and should be kept at a stable dose throughout the study. NSAIDs, acetaminophen, tramadol, codeine, hydrocodone and propoxyphene taken as needed are allowed but may not be taken 24 hours prior to any study visit. Oral and inhaled corticosteroids taken as needed are allowed but may not be taken 24 hours prior to any study visit.
- •Subjects must have discontinued high potency opiates including (but not limited to): oxycodone, oxymorphone, fentanyl, levorphanol, buprenorphine, methadone, hydromorphone, and morphine at least 4 weeks prior to Baseline Visit.
排除标准
- •Female who is pregnant or breastfeeding.
- •Prior exposure to Janus activated kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib).
- •Prior exposure to any investigational or approved biologic RA therapy.
- •Receipt of any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug (whichever is longer) prior to Week 0 Visit.
- •Current or expected need of other immunosuppressant medications, except methotrexate. Use of oral intake of > 10 mg prednisone/day or equivalent corticosteroid therapy (see inclusion criterion 7).
- •Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 8 weeks prior to the Week 0 Visit.
- •Screening laboratory values meeting the following criteria:
- •Serum aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 × ULN
- •Estimated glomerular filtration rate (eGRF) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73 m²
- •Total white blood cell count (WBC) < 3,000/µL
- •Absolute neutrophil count (ANC) < 1,200/µL
- •Platelet count < 100,000/µL
- •Absolute lymphocytes count < 750/ µL
- •Hemoglobin < 9 gm/dL
研究组 & 干预措施
Upadacitinib 3 mg BID
Experimental
Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.
干预措施: Upadacitinib (Drug)
Placebo
Placebo Comparator
Participants received placebo capsules twice daily for 12 weeks.
干预措施: Placebo (Drug)
Upadacitinib 6 mg BID
Experimental
Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.
干预措施: Upadacitinib (Drug)
Upadacitinib 12 mg BID
Experimental
Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.
干预措施: Upadacitinib (Drug)
Upadacitinib 18 mg BID
Experimental
Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.
干预措施: Upadacitinib (Drug)
Upadacitinib 24 mg QD
Experimental
Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
干预措施: Upadacitinib (Drug)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
时间窗: Baseline and Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
次要结局
- Secondary: Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12(Week 12)
- Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12(Week 12)
- Percentage of Participants Achieving Clinical Remission Based on CDAI at Week 12(Week 12)
- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12(Baseline and Week 12)
- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12(Baseline and Week 12)
- Percentage of Participants Achieving Low Disease Activity (LDA) Based on CDAI at Week 12(Week 12)
研究者
研究点 (63)
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