Rheumatoid Arthritis Clinical Trial
Official title:
Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept
The purpose of this study, in patients with rheumatoid arthritis who have had an incomplete response to etanercept and methotrexate (MTX), are to evaluate: safety and evidence of therapeutic benefit of infliximab and methotrexate, the levels (pharmacokinetics) of etanercept and infliximab and antibodies (immunogenicity) to etanercept and infliximab in patients blood, whether switching from etanercept to infliximab changes progression of structural damage over the study period, and whether specific markers in the blood (pharmacodynamics) correlate with therapeutic response or benefit.
Therapeutic agents designed to bind and block the biological activities of tumor necrosis
factor-alpha (TNFa) have been shown to be effective in the treatment of rheumatoid arthritis
(RA). Two anti-TNFa agents are currently marketed for the treatment of RA; etanercept
(Enbrel®) and infliximab (REMICADE®). Clinical trials have shown that both of these agents
rapidly improve signs and symptoms associated with RA in the majority of patients. Moreover,
they slow, and may even arrest or improve, the joint structural damage that accompanies RA.
While infliximab and etanercept are designed to block the biological activities of TNFa,
these agents are sufficiently different in their structure that they may have distinct, as
well as overlapping, mechanisms of action. The clearest evidence of this possibility can be
inferred from their differential activities in certain diseases such as Crohn's disease in
which infliximab, but not etanercept, shows beneficial therapeutic activity. The mechanism
of their differential biological activities is not known. That infliximab and etanercept
show differential activities in other diseases suggests that they may also have distinct
effects in RA.
The question of whether or not patients who fail to respond to or incompletely respond to
etanercept can still respond to infliximab has potentially important therapeutic
implications. Evidence that such patients respond to infliximab could support the notion
that these agents have important differences in their mechanisms of action, or could be
explained by the presence of antibodies to etanercept. More importantly, it would suggest
that therapeutic failure of one TNFa-blocker does not necessarily predict failure of all
TNFa-targeting agents. Such a finding could open important therapeutic alternatives to RA
patients and is of clear importance because this class of biologics (biologic agent)
represents the most significant advance to date in the treatment of RA.
This initial open-label, pilot study will be performed in approximately 24 patients with RA
who have who have achieved some therapeutic benefit from treatment with concomitant
etanercept and MTX for a minimum of 3 months, but the response must be an incomplete
response, and patients must have a minimum of 9 tender and 6 swollen joints while receiving
concomitant etanercept and MTX. It will assess safety and evidence of therapeutic benefit of
infliximab in this patient population. The study will examine any differences in the
pharmacokinetics and immunogenicity of etanercept and infliximab in patients who are
incomplete responders to etanercept.
This is an open-label, exploratory study and no formal hypothesis is being tested. This
study will provide a preliminary assessment of safety and evidence of therapeutic benefit of
infliximab plus MTX in patients with RA who are incomplete responders to etanercept plus
MTX. One group will receive intravenous infliximab infusions at a dose of 3 mg/kg at weeks
0, 2, 6 14 and 22. The second group will receive etanercept injections, 25 mg subcutaneously
twice weekly from week 0 through 16 and may receive intravenous infliximab infusions at 3
mg/kg on weeks 16, 18 & 22.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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