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

Psoriatic Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680159
• Other study ID #: TA-650-24
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2012
• Last updated: April 9, 2015
• Start date: July 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis
• Psoriatic Erythroderma
• Pustular Psoriasis (Excluding a Localized)

Intervention

Drug:
• TA-650

Locations

Country	Name	City	State
Japan	Investigational site	Chubu
Japan	Investigational site	Chugoku
Japan	Investigational site	Hokkaido
Japan	Investigational site	Kanto
Japan	Investigational site	Kinki
Japan	Investigational site	Kyushu
Japan	Investigational site	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving 75% improvement in the Psoriasis Area and Severity Index (PASI) score		Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period	No
Secondary	PASI score		Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period	No
Secondary	Physician Global Assessment (PGA) for skin lesions (Only for patients with plaque psoriasis)		Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period	No
Secondary	Visual Analog Scale(VAS) of pain assessment by subjects (Only for patients with psoriatic arthritis)		Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period	No
Secondary	Assessment of severity (Only for patients with pustular psoriasis)		Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period	No