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

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Pustular Psoriasis (Excluding a Localized)

Plaque Psoriasis

Psoriatic Arthritis

Psoriatic Erythroderma

Treatments

Drug: TA-650

Study type

Interventional

Funder types

Industry

Identifiers

NCT01680159

TA-650-24

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

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.