Effects of Tocilizumab (RoACTEMRA) on biomarkers in synovial tissue of patients with rheumatoid arthritis

Phase 4

Withdrawn

Conditions: Rheumatiod Arthritis
10003816

Registration Number: NL-OMON36162

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in CD68+ macrophages in the synovium between<br /><br>baseline and week 2 after treatment with tocilizumab.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The clinical severity of the affected joints during treatment will be evaluated<br /><br>at each visit using the following parameters:<br /><br>* Tender joint count (28 joints)<br /><br>* Swollen joint count (28 joints)<br /><br>* Patients visual analogue scale (VAS) of global disease activity<br /><br> Patients VAS of pain<br /><br> CRP<br /><br>* Erythrocyte sedimentation rate (ESR).</p><br>