A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis

Psoriatic Arthritis Clinical Trial

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.

Clinical Trial Description

• Patients with plaque psoriasis or psoriatic arthritis:

1. Screening Period:

TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours.

2. Increased Dose Period:

If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours.

• Patients with pustular psoriasis or psoriatic erythroderma:

TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis
• Psoriatic Erythroderma
• Pustular Psoriasis (Excluding a Localized)

• NCT number: NCT01680159
• Study type: Interventional
• Source: Mitsubishi Tanabe Pharma Corporation
• Status: Completed
• Phase: Phase 3
• Start date: July 2012
• Completion date: March 2015