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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TA-650
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Infliximab, REMICADE, TA-650, psoriasis

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TA-650

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
From 0 (best) to 100 (worst)
Assessment of Severity (Only for Patients With Pustular Psoriasis)
From 0 (best) to 17 (worst)

Full Information

First Posted
August 28, 2012
Last Updated
January 23, 2017
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01680159
Brief Title
A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis, Psoriatic Arthritis, Pustular Psoriasis (Excluding a Localized), Psoriatic Erythroderma
Keywords
Infliximab, REMICADE, TA-650, psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TA-650
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TA-650
Primary Outcome Measure Information:
Title
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Description
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.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Secondary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI) Score
Description
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.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Title
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Description
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
Time Frame
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Title
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Description
From 0 (best) to 100 (worst)
Time Frame
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Title
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Description
From 0 (best) to 17 (worst)
Time Frame
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hideshi Torii, MD
Organizational Affiliation
Social Insurance Central General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubihsi Tanabe Pharma Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hidemi Nakagawa, MD
Organizational Affiliation
The Jikei University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational site
City
Chubu
Country
Japan
Facility Name
Investigational site
City
Chugoku
Country
Japan
Facility Name
Investigational site
City
Hokkaido
Country
Japan
Facility Name
Investigational site
City
Kanto
Country
Japan
Facility Name
Investigational site
City
Kinki
Country
Japan
Facility Name
Investigational site
City
Kyushu
Country
Japan
Facility Name
Investigational site
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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