A Study Evaluating Infliximab Treatment for Chinese Subjects With Moderate to Severe Plaque-type Psoriasis
The purpose of this study is to determine the superiority and efficacy of 5mg/kg infliximab induction therapy in patients with moderate to severe plaque-type psoriasis compared with placebo. As described in the title of the trial, placebo is used as a control to the trial drug. 2 groups of eligible patients are separately given trial drug or placebo for treatment, a crossover would be met on week 10. The assessment of efficacy and safety are done in each visit until the 26 week follow up visit, when the trial is complete.
The primary objective of this study is to determine the safety and efficacy of 5mg/kg infliximab induction therapy in patients with moderate to severe plaque-type psoriasis compared with placebo. Secondary objectives of this study are to assess the efficacy of maintenance infliximab therapy, to assess the effects of infliximab on Dematology Life Quality Index (DLQI) and to assess the safety of infliximab therapy. Adult Chinese patients must have had a diagnosis of plaque-type psoriasis for at least 6 months prior to screening and be candidates for phototherapy or systemic therapy. In addition, patients must have a baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved. The eligible patients will be randomized to infliximab or placebo group at 2:1 ratio. A patient assigned to infliximab treatment will receive 5 mg/kg infliximab intravenous (directly into the vein) infusions at weeks 0, 2, and 6 followed by a maintenance regimen of 5mg/kg infliximab iv every 8 weeks through week 22. Placebo iv infusions will be given at weeks 10, 12, and 16 to maintain the blind. A patient assigned to placebo treatment will receive placebo infusions at weeks 0, 2, 6, 14, and 22. At week 10, patients will be crossover to infliximab therapy (5mg/kg) in a double-blind fashion and receive infliximab at week 10, 12 and 16. Infusions should be given over approximately 2 hours. Infliximab arm: 5mg/kg infliximab iv injection at week 0, 2, 6, 14, 22. Placebo injection at week 10, 12, 16. Placebo arm: placebo at week 0, 2, 6, 14, 22. Infliximab injection at week 10, 12, 16.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Xian-Janssen Pharmaceutical Ltd.
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01177800
- Information obtained from ClinicalTrials.gov on November 22, 2012
Medical and Biotech [MESH] Definitions
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.
A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.
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