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

Study Overview
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Brief Summary
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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
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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.

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

Intervention / Treatment
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* Drug: TA-650


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA-650<br> | Drug: TA-650<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infliximab, REMICADE, TA-650, psoriasis