Conditions: Plaque Psoriasis Psoriatic Arthritis Pustular Psoriasis (Excluding a Localized) Psoriatic Erythroderma
Keywords: Infliximab REMICADE TA-650 psoriasis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 51
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None

Interventions: intervention 1: TA-650
Intervention descriptions: intervention 1: None

Protocol document: