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

NCT ID: NCT01680159

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-03-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TA-650

Group Type: EXPERIMENTAL

TA-650

Intervention Type: DRUG

Interventions

TA-650

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hideshi Torii, MD

Role: STUDY_DIRECTOR

Social Insurance Central General Hospital

Kazuoki Kondo, MD

Role: STUDY_DIRECTOR

Mitsubihsi Tanabe Pharma Corporation

Hidemi Nakagawa, MD

Role: STUDY_CHAIR

The Jikei University School of Medicine

Locations

Investigational site

Chugoku, , Japan

Investigational site

Chūbu, , Japan

Investigational site

Hokkaido, , Japan

Investigational site

Kanto, , Japan

Investigational site

Kinki, , Japan

Investigational site

Kyushu, , Japan

Investigational site

Tōhoku, , Japan

Countries

Japan

Other Identifiers

TA-650-24

Identifier Type: -

Identifier Source: org_study_id