NCT01680159

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	TA-650

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-09-07
• Last updated: 2026-01-08
• Results posted: 2017-03-13

Locations

7 sites across 1 country: Japan