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

This study is currently recruiting participants.
Verified March 2013 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01680159
First received: August 28, 2012
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Plaque Psoriasis
Psoriatic Arthritis
Pustular Psoriasis (Excluding a Localized)
Psoriatic Erythroderma
 Drug: TA-650
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PASI score [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period ] [ Designated as safety issue: No ]
  • Physician Global Assessment (PGA) for skin lesions (Only for patients with plaque psoriasis) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TA-650 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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680159

Contacts
Contact: Clinical Trials Information Desk cti-inq-ml@ml.mt-pharma.co.jp

Locations
Japan
Investigational site Recruiting
Chubu, Japan
Investigational site Recruiting
Chugoku, Japan
Investigational site Recruiting
Hokkaido, Japan
Investigational site Recruiting
Kanto, Japan
Investigational site Recruiting
Kinki, Japan
Investigational site Recruiting
Kyushu, Japan
Investigational site Recruiting
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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01680159     History of Changes
Other Study ID Numbers: TA-650-24
Study First Received: August 28, 2012
Last Updated: March 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Infliximab
REMICADE
TA-650
psoriasis

Additional relevant MeSH terms:
Psoriasis
Arthritis
Arthritis, Psoriatic
Dermatitis, Exfoliative
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
 Spondylitis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on May 19, 2013