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Efficacy and Safety of Infliximab Therapy in Patients with Psoriasis - Article


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Infliximab

Remicade



Clinical Trial: Efficacy and Safety of Infliximab Therapy in Patients with Psoriasis

This study has been completed.

Sponsored by: Centocor
Information provided by: Centocor

Purpose

The purpose of this trial was to study the efficacy and safety of infliximab therapy in patients with psoriasis. Subjects were randomized to 3 treatment groups (3 or 5 mg/kg infliximab or placebo). Infliximab treated subjects received 3 or 5 mg/kg induction therapy compared to placebo. At week 14, subjects in each infliximab treatment group were randomized every 8 weeks to maintenance therapy or as needed therapy depending on PASI (Psoriasis Area and Severity Index) response. The placebo group crossed over to 5 mg/kg infliximab at week 16.

Condition Treatment or Intervention Phase
Psoriasis
 Drug: Infliximab
Phase III

MedlinePlus related topics:  Psoriasis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title: Double-Blind, Placebo-Controlled Trial Evaluating Efficacy and Safety of Infliximab Induction Therapy followed by Multiple Regimens of Infliximab Maintenance Therapy in Patients with Moderate to Severe Psoriasis

Further Study Details: 

- Phase: 3

  • Study Type: Multi-center, randomized, double-blind, placebo-controlled
  • Overall Status: Enrollment completed

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Adults with plaque psoriasis who were candidates for phototherapy or systemic therapy and had a PASI score ≥ 12 and at least 10% of their body surface area involved

More Information

Study ID Numbers:  C0168T44
Record last reviewed:  March 2005
Last Updated:  March 31, 2005
Record first received:  March 31, 2005
ClinicalTrials.gov Identifier:  NCT00106847
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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