NCT01532570CompletedPhase 3
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
Tanabe Pharma Corporation6 sites in 1 country18 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Tanabe Pharma Corporation
- Enrollment
- 18
- Locations
- 6
- Primary Endpoint
- Percentage of Participants With Complete Response at Week 30
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TA-650
Experimental
Intervention: TA-650 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Percentage of Participants With Complete Response at Week 14 and 54(Week 14, Week 54)
- Imaging Findings:Endoscopic Examination for Intestinal BD(Week 14, Week 30, Week 54)
- Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD(Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54)
- Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD(Week 14, Week 30, Week 54)
- Imaging Findings: Brainstem MRI for Chronic Neuro-BD(Week 14, Week 30, Week 54)
- Imaging Findings: CT, PET/CT for Vascular-BD(Week 14, Week 30, Week 54)
- Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD(Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54)
- Concentration of Inflammatory Biomarker (CRP) of Vascular BD(Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54)
- Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD(Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54)
- Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD(Week 0, Week 14, Week 30, Week 54)
- Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD(Week 0, Week 14, Week 30, Week 54)
- The Number of Improved Intestinal BD Patients From Baseline(Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54)
- Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients(Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54)
- Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients(Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54)
Investigators
Study Sites (6)
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