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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation

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

Original Primary Outcome: Global Assessment of improvement using for Specific Clinical Symptom and Imaging Findings and Biomarkers [ Time Frame: Week 30 ]

Current Secondary Outcome:

• 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,
  
  

  Original Secondary Outcome:

  • Global Assessment of improvement using for Specific Clinical Symptom and Imaging Findings and Biomarkers [ Time Frame: Week 14, Week 54 ]
  • Patient General Visual Analogue Scale [ Time Frame: Week 0, 2, 6, then every 4 weeks after Week 14 up to Week 46 ]
  • Imaging Findings： Endoscopic examination for Intestinal BD, MRI for Neuro-BD, CT etc for Vascular BD [ Time Frame: Week 14, Week 30, Week 54 ]
  • Inflammatory Biomarker ( CRP etc) [ Time Frame: Week 0, 2, 6, then every 4 weeks after Week 14 up to Week 46 ]
  • Cell Counts and IL-6 concentration in CSF for Neuro-BD [ Time Frame: Week 14, Week 30, Week 54 ]
  • 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 ]

  
  
  Information By: Mitsubishi Tanabe Pharma Corporation
  

  Dates:
  Date Received: February 6, 2012
  Date Started: January 2012
  Date Completion:
  Last Updated: October 25, 2016
  Last Verified: October 2016
  

  

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