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~30% of RA patients treated with ACTEMRA/RoACTEMRA achieved a DAS28 remission at 6 months, regardless of  concomitant treatment and prior therapy

Phase III Clinical Trials

ACTEMRA/RoACTEMRA (Tocilizumab): Phase III Clinical Trials in RA

ACTEMRA/RoACTEMRA (tocilizumab) has been evaluated in a broad range of patient populations in the most comprehensive clinical development programme supporting a first biologic licence application for an RA treatment – with more than 4,200 patients enrolled.1,2

Study populations enrolled in the clinical programme had a balanced geographical distribution.

Geographical distribution of ACTEMRA/RoACTEMRA clinical studies

Clinical trials in a broad range of patient populations with RA

The efficacy of ACTEMRA/RoACTEMRA in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multicentre Phase III studies.

  • AMBITION (ACTEMRA versus Methotrexate double-Blind Investigative Trial In mONotherapy).3
  • OPTION (tOcilizumab Pivotal Trial in methotrexate Inadequate respONders).4
  • TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy).5
  • LITHE (tociLIzumab safety and THE prevention of structural joint damage) (study WA17823).1,2
  • RADIATE (Research on Actemra Determining effIcacy after Anti-TNF failurEs).6

All studies enrolled patients ≥18 years of age with moderate to severe active RA diagnosed according to the American College of Rheumatology (ACR) criteria and who had at least eight tender and six swollen joints at baseline.

Overview of the ACTEMRA/RoACTEMRA Phase III programme1–4
  AMBITION OPTION TOWARD LITHE RADIATE
Patient population MTX-naïve or MTX-free for ≥6 months Inadequate response to MTX Inadequate response to DMARD Inadequate response to MTX Inadequate response to anti-TNFs
Patients enrolled, N 673 623 1,220 1,196 499
Background DMARD(s) None (monotherapy) MTX ≥1 DMARD (MTX, chloroquine, hydro-xychlo-roquine, parenteral gold, sulpha-salazine, azathioprine and leflunomide) MTX MTX
Control arm MTX MTX plus placebo DMARD(s) plus placebo MTX plus placebo MTX plus placebo
Primary endpoint ACR20 at Week 24 ACR20 at Week 24 ACR20 at Week 24 ACR20 at Week 24; prevention of joint damage and improved physical function at Week 52 ACR20 at Week 24
Protocol number WA17824 WA17822 WA18063 WA17823 WA18062
Clinical-Trials.gov identifier 00109408 00106548 00106574 00106535 00106522
 

Detailed results of these trials can be found in the Efficacy and Safety and Tolerability sections of the website.

References:
1. RoACTEMRA® (tocilizumab) Summary of Product Characteristics. Roche Registration Limited. June 2010. 2. European Medicines Agency. European Public Assessment Report: RoActemra (EMEA/H-C-955). 2009. 3. Jones G, et al. Ann Rheum Dis. 2010; 69:88-96. 4. Smolen JS, et al. Lancet 2008; 371:987–997. 5. Genovese MC, et al. Arthritis Rheum 2008; 58:2968–2980. 6. Emery P, et al. Ann Rheum Dis 2008; 67:1516–1523.

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