In rheumatoid arthritis (RA) patients with insufficient response to disease modifying anti-rheumatic drugs (DMARDs) it is unknown whether addition of tocilizumab (TCZ) to conventional synthetic (cs) DMARDs has superior efficacy compared to addition of prednisone. If so, TCZ should be considered instead of prednisone. On the other hand administration of prednisone may be a highly cost-effective approach. Comparative trial data are lacking.
To assess the efficacy of adding subcutaneous TCZ to csDMARD therapy compared with adding oral prednisone (10 mg daily).
This study is a multicenter, pragmatic, randomized, open label trial coordinated by the Department of Rheumatology & Clinical Immunology, University Medical Center (UMC) Utrecht.
RA patients meeting the 2010 ACR/EULAR criteria for RA, with active disease defined by a clinical disease activity index (CDAI)>10 and at least 1 swollen joint of the 28 joint count, who are on stable treatment with csDMARDs for ≥ 8 weeks prior to screening, and have had treatment with ≥2 csDMARDs. Previous use of ≤ 1 TNF inhibitor is permitted.
Patients will be randomized in a 1:1 ratio to receive either TCZ (subcutaneous 162 mg/week) or prednisone (oral 10 mg/day) in addition to csDMARD therapy.
Main study parameters/endpoints
Change in CDAI from baseline to 12 months
Matthijs van der Leeuw