EUCTR2014-003558-15-LV进行中（未招募）1 期
A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects with Active Psoriatic 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
- 220
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, 18 years of age or older.
- •2. PsA diagnosis of at least 3 months duration prior to the date of first Screening with CASPAR confirmed diagnosis at Screening.
- •3. Have active psoriasis defined by at least 1 psoriasis lesion = 2 cm diameter in areas other than the axilla or groin.
- •4. Have active arthritis defined by minimum disease activity criteria:
- •= 3 swollen joints (based on 66 joint counts) at Screening.
- •= 3 tender joints (based on 68 joint counts) at Screening.
- •5. On a stable dose of MTX defined as:
- •Oral or parenteral treatment = 3 months,
- •On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline
- •Stable MTX dose of = 10 mg/week and < the upper limit of the applicable approved local label.
- •Subject can also be on stable doses of NSAIDs, sulfasalazine and/or hydroxychloroquine as 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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Prior exposure to any TNF inhibitors including:
- •- Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or for safety concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior to the Baseline visit.
- •- Subjects on prior adalimumab may not be enrolled in the study.
- •- Prior exposure to other non-TNF inhibitor biological DMARDs will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the Baseline visit.
- •2. Current treatment with traditional oral DMARDs, including csDMARDs, (except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit.
- •Subject may have prior exposure to JAK inhibitors or to PDE4 inhibitors as long as they have been off therapy for at least 5 half-lives.
- •3. Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within 30 days of the Baseline visit.
- •4. Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. 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 (or < 1200 cells/µL for subjects of African descent who are black),
- •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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