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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01532570
First received: February 6, 2012
Last updated: October 25, 2016
Last verified: October 2016
  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: 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:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Percentage of Participants With Complete Response at Week 30 [ Time Frame: Week 30 ]

    We defined the patient who met the following criteria as the complete responders.

    The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, Computed tomography (CT) or Positron emission tomography/Computed tomography (PET/CT) findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0.



Secondary Outcome Measures:
  • Percentage of Participants With Complete Response at Week 14 and 54 [ Time Frame: Week 14, Week 54 ]

    We defined the patient who met the following criteria as the complete responders.

    The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, CT or PET/CT findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0.


  • Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD [ Time Frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 ]

    The VAS evaluation measured using the "General VAS evaluation From" and the range is from 0 to 100 mm. The best condition per one week before evaluation visit for the clinical symptoms associated with each BD is defined as "0" and the worst condition is defined as "100".

    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.


  • Imaging Findings:Endoscopic Examination for Intestinal BD [ Time Frame: Week 14, Week 30, Week 54 ]
    The investigator assessed the length of the major axis of the principal intestinal ulcer at day of evaluation and scored in accordance with the following categories, "Healed/scarred, Reduced to =< 25%, Reduced to > 25% to =< 50% or Reduced to > 50%/no change/increased" in the principal intestinal ulcer compared to size at Week 0.

  • Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD [ Time Frame: Week 14, Week 30, Week 54 ]
    Changes in brain MRI findings were scored at day of evaluation, in accordance with the following categories, "No high-intensity areas, Reduction or No changes/increase" in the size of high-intensity areas compared to Week 0.

  • Imaging Findings: Brainstem MRI for Chronic Neuro-BD [ Time Frame: Week 14, Week 30, Week 54 ]
    Changes in brainstem MRI findings were scored at day of evaluation, in accordance with the following categories, "Unchanged or Reduced" in the brainstem area compared to Week 0.

  • Imaging Findings: CT, PET/CT for Vascular-BD [ Time Frame: Week 14, Week 30, Week 54 ]
    Changes in CT or PET/CT findings were scored at day of evaluation, in accordance with the following categories, "Improves, Unchanged or Worsened" by comparison with those at Week 0.

  • Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD [ Time Frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 ]
    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  • Concentration of Inflammatory Biomarker (CRP) of Vascular BD [ Time Frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 ]
    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  • Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD [ Time Frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 ]
    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  • Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD [ Time Frame: Week 0, Week 14, Week 30, Week 54 ]
    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  • Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD [ Time Frame: Week 0, Week 14, Week 30, Week 54 ]
  • The Number of Improved Intestinal BD Patients From Baseline [ Time Frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 ]

    The investigator assessed clinical symptoms associated with intestinal BD in one week before the day of evaluation as " No symptom, Very slightly poor, Slightly poor, Poor or Extremely poor".

    We calculated improved patients in comparison with those for Week 0.


  • Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients [ Time Frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54 ]
    The investigator assessed the clinical symptoms associated with neuro-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as "No symptom, Improved, Unchanged or Worsened".

  • Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients [ Time Frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54 ]
    The investigator assessed the clinical symptoms associated with vascular-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as "No symptom, Improved, Unchanged or Worsened".


Enrollment: 18
Study Start Date: January 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532570

Locations
Japan
Investigational site
Chubu, Japan
Investigational site
Hokkaido, Japan
Investigational site
Kanto, Japan
Investigational site
Kinki, Japan
Investigational site
Kyusyu, Japan
Investigational site
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 Kitasato University Kitasato Institute Hospital
Study Director: Shunsei Hirohata, MD Kitasato University School of Medicine
Study Director: Kazuoki Kondo, MD Mitsubihsi Tanabe Pharma Corporation
  More Information

Publications:
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
Results First Received: June 15, 2016
Last Updated: October 25, 2016

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
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular

ClinicalTrials.gov processed this record on April 21, 2017