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

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2009-011268-13-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify whether rituximab therapy or anti-TNF therapy is more effective in improving the clinical symptoms, signs, physical function and health-related quality of life of patients with active rheumatoid arthritis.;Secondary Objective: 1)What is the relative cost effectiveness of rituximab and anti-TNF therapy in patients with active RA? 2) Does the patient's mood affect response to, or toxicity from biologic therapy? 3) Do the histological appearances of the patient's synvoial biopsy affect the response to rituximab or anti-TNF therapy?;Primary end point(s): Mean change in Disease Activity Score (DAS28) between 0 and 12 months