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Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions

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:
NCT01532570
First received: February 6, 2012
Last updated: March 14, 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 in patients with Behcet's disease ( BD ) with special lesions after the administration of TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to week 46.


Condition Intervention Phase
Behcet's Disease
Behcet Syndrome
Neuro-Behcet's Disease
 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
Official Title: To Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Patients With Behcet's Disease ( BD ) With Special Lesions After the Administration of TA-650

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Global Assessment of improvement using for Specific Clinical Symptom and Imaging Findings and Biomarkers [ Time Frame: Week 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Assessment of improvement using for Specific Clinical Symptom and Imaging Findings and Biomarkers [ Time Frame: Week 14, Week 54 ] [ Designated as safety issue: No ]
  • Patient General Visual Analogue Scale [ Time Frame: Week 0, 2, 6, then every 4 weeks after Week 14 up to Week 46 ] [ Designated as safety issue: No ]
  • Imaging Findings： Endoscopic examination for Intestinal BD, MRI for Neuro-BD, CT etc for Vascular BD [ Time Frame: Week 14, Week 30, Week 54 ] [ Designated as safety issue: No ]
  • Inflammatory Biomarker ( CRP etc) [ Time Frame: Week 0, 2, 6, then every 4 weeks after Week 14 up to Week 46 ] [ Designated as safety issue: No ]
  • Cell Counts and IL-6 concentration in CSF for Neuro-BD [ Time Frame: Week 14, Week 30, Week 54 ] [ Designated as safety issue: No ]
  • Change from Baseline in Specific Clinical Symptom for each type BD [ Time Frame: Week 0, 2, 6, then every 4 weeks after Week 14 up to Week 46 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TA-650 Drug: TA-650
TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who were diagnosed with the complete or incomplete type of Behcet's disease according to "The criteria for a diagnosis of Behcet's disease, Ministry of Health, Labour and Welfare in Japan (partially revised in 2010)"
  • Patients who have special lesions despite having received conventional treatments for special lesions, or patients who cannot receive conventional treatments due to intolerability.
  • Patients who have clinical symptoms associated with each special lesions.

Exclusion Criteria:

  • Patients with intestinal, neuro-, vascular Behcet's disease in whom a differential diagnosis of each Behcet's disease from other conditions．
  • Patients who have received treatment with infliximab within 1 year before enrollment for another purpose than treating special lesions; or patients whose previous treatment with infliximab was discontinued due to adverse events.
  • Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving acquirement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532570

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

Locations
Japan
Investigational site Recruiting
Chubu, Japan
Investigational site Recruiting
Hokkaido, Japan
Investigational site Recruiting
Kanto, Japan
Investigational site Recruiting
Kinki, Japan
Investigational site Recruiting
Kyusyu, Japan
Investigational site Recruiting
Tohoku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Yoshiaki Ishigatsubo, MD, Ph.D Yokohama City University Graduate School of Medicine
Study Director: Toshifumi Hibi, MD Keio University School of Medicine
Study Director: Shunsei Hirohata, MD Kitasato University School of Medicine
Study Director: Kazuoki Kondo, MD Mitsubihsi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01532570     History of Changes
Other Study ID Numbers: TA-650-23
Study First Received: February 6, 2012
Last Updated: March 14, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Behcet's disease
intestinal Behcet's disease
neuro-Behcet's disease
vascular Behcet's disease

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
 Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases

ClinicalTrials.gov processed this record on June 13, 2013