A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs

Vertex Pharmaceuticals Incorporated0 个研究点目标入组 40 人开始时间: 2013年3月22日最近更新: 2015年2月16日

适应症

试验速览

暂无简介。

•Male and female subjects 18 to 65 years of age (inclusive)
•Diagnosis of RA
•Swollen joint count of =6 out of 66 joints and tender joint count of =6 out of 68 joints
•Seropositivity based on either a positive rheumatoid factor or anti cyclic citrullinated peptide antibody at screening -OR- known erosive disease based on previous X-ray report or erosions detected on screening hand and foot X-ray
•Baseline CRP level or Westergren erythrocyte sedimentation rate =1.2 × upper limit of normal
•Receiving stable therapy with 1 of the following DMARDs: methotrexate, sulfasalazine, leflunomide, anti-malarial drug, or penicillamine
•Palpable 2+ synovitis of the wrist or =2 MCPs in the MRI-designated hand
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
•Inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature
•Planned surgery during the study
•History of alcohol or drug abuse, or excessive alcohol consumption
•History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
•Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant

发起方