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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

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.