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

Phase 3

Completed

Conditions: Behcet Syndrome
Neuro-Behcet's Disease
Behcet's Disease

Interventions: Drug: TA-650

Registration Number: NCT01532570

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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 Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TA-650	TA-650	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Response at Week 30	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

Name	Time	Method
Percentage of Participants With Complete Response at Week 14 and 54	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.
Imaging Findings:Endoscopic Examination for Intestinal BD	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.
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	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: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD	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	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	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.
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD	Week 0, 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	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	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	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	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.
The Number of Improved Intestinal BD Patients From Baseline	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	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	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".