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Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequen...

Update Il y a 4 ans
Reference: EUCTR2006-002027-16

Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action

Woman and Man

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Extract

To assess the clinical efficacy of subcutaneous certolizumab pegol 400 mg at week 6, following administration at 0, 2 and 4 weeks for the treatment of signs and symptoms of active Crohn’s Disease (CDAI between 220 and 450 inclusive: scored over 7 days before the first administration of the study drug) in patients who have previously received and responded to infliximab, but who no longer have a sustained response and / or tolerance to infliximab.

Inclusion criteria

  • Certolizumab pegol in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab

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