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

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 220 人开始时间: 2015年4月27日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•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

•1. Prior exposure to any TNF inhibitors including adalimumab.
•? 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.

发起方