A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.0 个研究点目标入组 342 人开始时间: 2012年11月20日最近更新: 2013年9月30日

适应症

试验速览

暂无简介。

•Subject must be =18 years of age on the day of signing the informed consent.
•RA diagnosis and disease activity:
•Subject has a diagnosis of RA for at least 6 months prior to screening.
•Subject has active RA as defined by the presence of 6 swollen joints (of 66 joint count) AND 6 tender joints (of 68 joint count) at screening (Visit 1) and baseline (Visit 2).
•Subject has a C-reactive protein (CRP) blood level > 0.9 mg/dL from the central reference laboratory at screening.
•Subject is anti-cyclic citrullinated antibody positive and/or rheumatoid factor positive at screening.
•Subject is ACR functional Class I, II, or III.
•Subjects has received MTX for a minimum of 3 months with a regionally appropriate stable weekly dose (15-25 mg/wk for regions outside of Asia, 6–16 mg/week for Asia) for at least 4 wks prior to entering study.
•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 419
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Subject has inflammatory disease other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.
•Previous exposure to fostamatinib or other splenic tyrosine kinase (SYK) inhibitors.
•Previous exposure to TNF-alpha targeted therapy or any biological agents for RA.
•Subject has received any treatment listed below more recently than the indicated washout period prior to Screening.
•Prohibited Medications, Supplements, and Other SubstancesWashout Period Prior to Screening
•Disease modifying anti-rheumatic drugs such as but not limited to (not including cytotoxic agents):
•Leflunomide, cyclosporine, mycophenolate mofetil, azathioprine, corticosteroids (parenteral, intra-articular), sulfasalazine, hydroxychloroquine30 days (8 weeks for leflunomide unless subject undergoes standard cholestyramine or activated charcoal washout)
•Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents3 months
•Live vaccinations1 month
•Investigational medications30 days or 5 half lives of the investigational agent whichever is longer
•Bacille Calmette-Guerin (BCG) vaccination1 month

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.