Infliximab |
Remicade |
Clinical Trial: Efficacy and Safety of Infliximab Therapy in Patients with Psoriasis
This study has been completed.
|
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
- 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
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
Resources
- Infliximab (Drug Digest)
- Remicade (Drug Digest)

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