EUCTR2013-004019-37-DK进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 222
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
入选标准
- •1. Adult male or female, 18 years of age or older.
- •2. 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).
- •3. RA diagnosis at least 3 months from the date of first Screening.
- •4. Documented positive Rheumatoid Factor (RF) or Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody levels prior to or at Screening:
- •If RF and Anti-CCP Antibody tests are negative, documented evidence of prior erosions on radiographs or CT/MRI of hands is an acceptable alternative for meeting this inclusion criterion.
- •5. Have active RA defined by minimum disease activity criteria:
- •= 6 Swollen joints (based on 66 joint counts) at Screening,
- •= 6 Tender joints (based on 68 joint counts) at Screening,
- •hsCRP > Upper limit of normal at Screening.
- •6. Inadequate response to 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 = 10 mg/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.
- •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 104
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •1. Subject has previous exposure to Humira, other TNF inhibitors or other biological DMARDs.
- •2. Current treatment with traditional oral 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 1.
- •Subject could have been exposed to prior JAK inhibitors so long as they have been off therapy for 5 half-lives.
- •3. Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within the 30 days of first dose of study drug.
- •4. 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.
- •5. 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 /mm3,
- •AST or 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] (109/L),
- •Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
研究者
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