Psoriasis Clinical Trial
Official title:
A Long-Term Efficacy and Safety Study of Infliximab in the Treatment of Moderate to Severe Plaque-Type Psoriasis
This is a long-term, randomized, multi-center, open-label study of infliximab treatment in
adults with moderate to severe plaque-type psoriasis. This study is the long-term extension
of Study P04271 (NCT00251641); Study P04271 is a Phase 3b, randomized, parallel-group,
multicenter, open-label, 26-week study comparing the efficacy and safety of infliximab
versus methotrexate in the treatment of adult subjects with moderate to severe plaque-type
psoriasis. The objectives of this study are to assess the efficacy and safety of long-term
maintenance therapy versus intermittent therapy with 5 mg/kg infliximab in a moderate to
severe plaque-type psoriasis population.
During an interim safety evaluation of the trial, a higher incidence of serious and severe
infusion reactions was observed in the intermittent treatment arm, consisting of a
re-induction cycle (maximum of 4 infusions at 0, 2, 6 and 14 weeks) after a period of no
treatment compared with the maintenance arm (infusions every 8 weeks without an interruption
of treatment). Consequently, the sponsor has terminated the trial. The label will be updated
to reflect this new information relating to the use of a re-induction regimen with
infliximab.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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