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Clinical trials of Actemra

The AMBITION Study
The AMBITION study was published in March 2009. This study included 673 patients of Rheumatoid arthritis. The patients were divided into two groups, one received Tocilizumab & the other received Methotrexate. Study results showed that at week 24, there were more patients receiving Tocilizumab who reached ACR20/ ACR50/ ACR 70 than those on Methotrexate. Of the study participants, 69.9% of the Tocilizumab group vs. 52.5% of the methotrexate group achieved ACR 20 response. The percentage of patients reaching ACR 50 & ACR 70 was (ACR50/ ACR70) 44.1%/ 28% in Tocilizumab group vs. 33.5%/15.1% in methotrexate group. A fall in the white cell count & a rise in the lipid levels were seen more commonly in the Tocilizumab group.
The OPTION Study
The OTION study published in 2008 included 623 patients with Rheumatoid arthritis. The patients were divided into 3 groups. All the patients received Methotrexate & were given either Tocilizumab 8mg// kg (group 1) or Tocilizumab 4 mg/kg (group 2) or a placebo (group 3). Study results showed that at week 24, there were more patients receiving Tocilizumab who reached ACR20/ ACR50/ ACR 70 than those on placebo. Of the study participants, 59% of the Tocilizumab 8mg/kg group vs.48% of the Tocilizumab 4mg/kg group group & 26% of the placebo group achieved ACR 20 response. The most common side effect observed during the study was infection reported by six patients in the 8 mg/kg group, three in the 4 mg/kg group, and two in the placebo group.
The RADIATE study
The RADIATE study published in 2008, included 499 Rheumatoid arthritis patients with an inadequate response to TNF-alpha antagonists. The patients were divided into 3 groups. All the patients received Methotrexate & were given either Tocilizumab 8mg// kg (group 1) or Tocilizumab 4 mg/kg (group 2) or a placebo (group 3). ACR20 was achieved at 24 weeks by 50.0%, 30.4% and 10.1% of patients in the 8 mg/kg, 4 mg/kg and control groups, respectively.
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1)AMBITION study- Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study. Graeme Jones et al.

2)OPTION study-- Effect of interleukin-6 receptor inhibition with Tocilizumab in patients with rheumatoid arthritis (OPTION study):a double-blind, placebo-controlled, randomised trial. Josef S Smolen et al

3) RADIATE study IL-6 Receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-TNF biologics: results from a 24-week multicentre Randomised Placebo Controlled Trial. P Emery et al Ann Rheum Dis 

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Created on: April 2007
Last updated on: Feb 2015
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