Rheumatiod Arthritis
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: males/females suffering form RA according to the ACR/EULAR 2010 classification criteria active disease das 28 * 3.2 despite adequate MTX treatment ARA functional classes I, II and III * 18 and * 70 years of age stable MTX treatment (5 - 30 mg/week) for at least 28 days inflamed knee, ankle or wrist joint
Exclusion criteria
Exclusion criteria: Pregnancy; Breastfeeding; Subjects who are impaired, incapacitated, or incapable of completing study related assessments; Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus); Subjects who have previously received treatment with tocilizumab; Current use of oral corticosteroids (if exceeding a prednisone equivalent of 10 mg daily) or DMARDs other than MTX; intra-articular injections of corticosteroids 28 days or less before inclusion. Current use of TNF blocking agents, such as etanercept, adalimumab, infliximab, golimumab or certlizumab. Washout periods are depending on pharmacokinetic profile of the various agents Rituximab en abatacept washout Subjects with active vasculitis of a major organ system with the exception of rheumatoid nodules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in CD68+ macrophages in the synovium between baseline and week 2 after treatment with tocilizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical severity of the affected joints during treatment will be evaluated at each visit using the following parameters: * Tender joint count (28 joints) * Swollen joint count (28 joints) * Patient*s visual analogue scale (VAS) of global disease activity * Patient*s VAS of pain * CRP * Erythrocyte sedimentation rate (ESR). | — |
Countries
Netherlands
Outcome results
None listed