Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study

HS Greater Glasgow and Clyde0 个研究点开始时间: 2010年3月15日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•Patients with RA who meets the BSR guidelines for anti-TNF therapy and who: - fulfil the 1987 criteria of the ACR classification criteria for a diagnosis of RA - have failed standard therapy, as defined by a failure to respond or tolerate adequate therapeutic trials of at least 2 standard DMARDs, one of which must have been methotrexate - have not previously been treated with biologic therapy - have active disease, as measured by the modified disease activity score, and as defined in the current BSR guidelines - are sero-positive for rheumatoid factor or anti-CCP antibodies - age > 18 years of age
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•Patients will be excluded if they have any contraindication to anti-TNF therapy or rituximab therapy: - women who are pregnant or breast-feeding - unwillingness to use effective contraception - history of or current inflammatory joint disease or autoimmune disease other than RA - treatment with any investigational agent £ 4 weeks prior to baseline or < 5 half lives of the investigational drug - intra articular or parenteral corticosteroids £ 2 weeks prior to baseline. - active infection - septic arthritis within a native joint within the last 12 months - sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ - known HIV or hepatitis B/C infection - latent TB infection unless they have completed adequate antibiotic prophylaxis - malignancy (other than basal cell carcinoma) within the last 10 years - New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure - demyelinating disease - latex allergy or allergy to excipients in any of the study medications - any other contra-indication to the study medications as detailed in their summaries of product characteristics

发起方

HS Greater Glasgow and Clyde