A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available

Janssen-Cilag International NV0 个研究点目标入组 280 人开始时间: 2012年10月25日最近更新: 2014年8月11日

研究概览

暂无简介。

•Principal Inclusion Criteria in Lay Language (for a complete list of inclusion criteria refer to the protocol):
•- Be a male or female between 18 and 80 years of age, inclusive.
•- Have had a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening.
•-Positive test for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening.
•- Have active RA defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints at the time of screening and at baseline; and serum C-reactive protein >= 0.80 mg/dL at screening.
•- Have been treated with, and tolerated methotrexate (MTX) at dosages from 10 to 25 mg/week, inclusive (6 to 16 mg/week, inclusive, for patients in Japan), for a minimum of 6 months prior to screening. Subjects must have a stable MTX dose for a minimum of 8 weeks prior to screening.
•- Must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control.
•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 240
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Principal Exclusion Criteria in Lay Language (for a complete list of exclusion criteria refer to the protocol):
•- Have inflammatory diseases other than rheumatoid arthritis, such as Lupus
•- Is currently receiving treatment for RA other than methotrexate, NSAIDS, corticosteroids (e.g. prednisone), or pain medicines.
•- Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
•- Have received biologic agent for rheumatic disease in the past
•- Have a recent (2 months) serious infection
•- Have an active infection
•- Have had cancer within the past 5 years (except certain skin or cervical conditions)
•- Have abused substances or alcohol within the past 2 years
•– Have active Hepatitis B or C infection, or infective with HIV.
•- Have had active tuberculosis.
•- Have had exposure to tuberculosis without preventative treatment

发起方