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

• ClinicalTrials.gov Identifier: NCT01680159
• Recruitment Status: Completed
• First Posted: September 7, 2012
• Results First Posted: March 13, 2017
• Last Update Posted: March 13, 2017
• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Information provided by (Responsible Party): Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis; Psoriatic Arthritis; Pustular Psoriasis (Excluding a Localized); Psoriatic Erythroderma	Drug: TA-650	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: July 2012
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: TA-650	Drug: TA-650

Outcome Measures

Primary Outcome Measures :

1. Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period ]

   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 :

1. Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period ]
   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.
2. Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period ]

   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

3. Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period ]
   From 0 (best) to 100 (worst)
4. Assessment of Severity (Only for Patients With Pustular Psoriasis) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period ]
   From 0 (best) to 17 (worst)

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 75 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

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

More Information

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01680159
• Other Study ID Numbers: TA-650-24
• First Posted: September 7, 2012
• Results First Posted: March 13, 2017
• Last Update Posted: March 13, 2017
• Last Verified: November 2016

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Infliximab; REMICADE; TA-650; psoriasis

Additional relevant MeSH terms:

Arthritis, Psoriatic; Psoriasis; Dermatitis, Exfoliative; Arthritis; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Dermatitis; Skin Diseases, Eczematous