Z05 Efficacy and Safety of Infliximab(REMICADE) in active RA
Research type
Research Study
Full title
A Phase 4, Multicenter, Open-label, Assessor-blinded, Switch Study of the Efficacy and Safety of Infliximab (REMICADE®) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL®) or Adalimumab (HUMIRA®)
IRAS ID
6935
Sponsor organisation
Centocor BV
Eudract number
2007-003288-36
Clinicaltrials.gov Identifier
Research summary
A number of drugs are currently used for the treatment of Rheumatoid Arthritis (RA) and these include anti-tumour necrosis factor alpha (TNFa) agents. Therapeutic agents designed to bind and block the biological activities of TNFa have been shown to be effective in the treatment of RA. Three anti-TNFa agents are currently marketed for the treatment of RA. Etanercept (Enbrel©), Adalimumab (Humira©) and Infliximab (REMICADE©). All three work to block the biological activities of TNFa but they all work in different ways. Therefore, it is possible that though a patient may not respond to one type of these agents (TNFa blocker/inhibitor), they may respond to the other two. Switching patients to a second or even a third TNFa inhibitor has now become common in clinical practice. The question of whether or not patients who fail or inadequately respond to subcutaneously administered TNFa inhibitors can still respond to infliximab has potentially important therapeutic implications. Such a finding could open important therapeutic alternatives to patients with RA and is of clear importance because this class of biologics represents the most significant advance to date in the treatment of RA. The primary objective of this study is to evaluate the efficacy of infliximab at Week 10 in patients with active RA who are having an inadequate response to therapy with etanercept or adalimumab.
REC name
London - Riverside Research Ethics Committee
REC reference
08/H0706/112
Date of REC Opinion
20 Jan 2009
REC opinion
Further Information Favourable Opinion