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

• Patients with plaque psoriasis or psoriatic arthritis:

• 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.

• 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.

Inclusion criteria

• Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.
• Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter.

Exclusion criteria

• Patients who have guttate psoriasis.
• Patients who have drug-induced psoriasis
• Patients who have previously used any other biological products than infliximab.
• Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization.
• Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections
• Female patients who are pregnant, breast-feeding, or possibly pregnant.