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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis; Psoriatic Arthritis; Psoriatic Erythroderma; Pustular Psoriasis (Excluding a Localized)
• Intervention / Treatment: Drug: TA-650

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • 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, Japan
    • Investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 73 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TA-650	Drug: TA-650

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score	The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.	Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI) Score	Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.	Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)	The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions. 0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe	Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)	From 0 (best) to 100 (worst)	Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Assessment of Severity (Only for Patients With Pustular Psoriasis)	From 0 (best) to 17 (worst)	Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Investigators: Study Director: Hideshi Torii, MD, Social Insurance Central General Hospital; Study Chair: Hidemi Nakagawa, MD, The Jikei University School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: psoriasis; Infliximab; REMICADE; TA-650
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Dermatitis; Skin Diseases, Eczematous; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis, Psoriatic; Dermatitis, Exfoliative
• Other Study ID Numbers: TA-650-24