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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01532570 |
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Date of registration:
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06/02/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
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Scientific title:
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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 |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01532570 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yoshiaki Ishigatsubo, MD, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yokohama City University Graduate School of Medicine |
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Name:
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Toshifumi Hibi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kitasato University Kitasato Institute Hospital |
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Name:
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Shunsei Hirohata, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kitasato University School of Medicine |
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Name:
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Kazuoki Kondo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mitsubihsi Tanabe Pharma Corporation |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Behcet's Disease
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Neuro-Behcet's Disease
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Behcet Syndrome
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Intervention(s)
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Drug: TA-650
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Primary Outcome(s)
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Percentage of Participants With Complete Response at Week 30
[Time Frame: Week 30]
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Secondary Outcome(s)
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Imaging Findings: CT, PET/CT for Vascular-BD
[Time Frame: Week 14, Week 30, Week 54]
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Imaging Findings:Endoscopic Examination for Intestinal BD
[Time Frame: Week 14, Week 30, Week 54]
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Imaging Findings: Brainstem MRI for Chronic Neuro-BD
[Time Frame: Week 14, Week 30, Week 54]
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Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
[Time Frame: Week 0, Week 14, Week 30, Week 54]
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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]
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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]
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Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
[Time Frame: Week 14, Week 30, Week 54]
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Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
[Time Frame: Week 0, Week 14, Week 30, Week 54]
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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]
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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]
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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]
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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]
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Percentage of Participants With Complete Response at Week 14 and 54
[Time Frame: Week 14, Week 54]
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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]
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Secondary ID(s)
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TA-650-23
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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