EUCTR2013-002358-57-ES进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AbbVie Inc.
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult male or female, at least 18 years old.
- •2. Diagnosed with RA based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria for greater than or equal to 3 months.
- •3. Subjects must have been receiving oral or parenteral MTX therapy greater than or equal to 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study.
- •4. Subjects have been treated with 1 or 2 anti-TNF biologics for greater than 3 months but less than 3 years but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity within 1 year prior to initiating the study drug, provided that they did not exhibit, based on reported history, initial nonresponse to the agent (i.e., exclude subjects with no clinical response to initial treatment with anti-TNF biologic).
- •5. Have active RA as defined by the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) at Screening and Baseline Visits; greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits; hs-CRP greater than 7 mg/L.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 185
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Reported history of no clinical response to initial treatment with anti-TNF biologic.
- •2. Receipt of prior biologic therapy other than an anti-TNF (e.g., tocilizumab, rituximab, anakinra, or abatacept).
- •3. Prior exposure to JAK inhibitor (e.g., tofacitinib, baricitinib).
- •4. 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 initiating the study drug.
- •5. Current or expected need of other immunosuppressant medications, except MTX. Use of oral intake of greater than 10 mg prednisone/day or equivalent corticosteroid therapy.
- •6. Laboratory values meeting the following criteria within 4 weeks prior to initiating study drug: Serum aspartate transaminase (AST) or alanine transaminase (ALT) greater than 1.5 × ULN; Estimated glomerular filtration rate (eGRF) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula less than 40 mL/min/1.73 m2; Total white blood cell count (WBC) less than 3,000/µL; Absolute neutrophil count (ANC) less than 1,200 /µL; Platelet count less than 100,000/µL; Absolute lymphocytes count less than 500/ µL; Hemoglobin less than 9 gm/dL
研究者
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