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

Primary Purpose

Behcet's Disease, Behcet Syndrome, Neuro-Behcet's Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TA-650
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behcet's Disease focused on measuring Behcet's disease, intestinal Behcet's disease, neuro-Behcet's disease, vascular Behcet's disease

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TA-650

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Complete Response at 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
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
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
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
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
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
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
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
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
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
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
The Number of Improved Intestinal BD Patients From Baseline
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
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
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".

Full Information

First Posted
February 6, 2012
Last Updated
October 25, 2016
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01532570
Brief Title
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet's Disease, Behcet Syndrome, Neuro-Behcet's Disease
Keywords
Behcet's disease, intestinal Behcet's disease, neuro-Behcet's disease, vascular Behcet's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TA-650
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TA-650
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response at Week 30
Description
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.
Time Frame
Week 30
Secondary Outcome Measure Information:
Title
Percentage of Participants With Complete Response at Week 14 and 54
Description
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.
Time Frame
Week 14, Week 54
Title
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Description
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.
Time Frame
Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Title
Imaging Findings:Endoscopic Examination for Intestinal BD
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Imaging Findings: Brainstem MRI for Chronic Neuro-BD
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Imaging Findings: CT, PET/CT for Vascular-BD
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Description
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.
Time Frame
Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Title
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Description
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.
Time Frame
Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Title
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Description
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.
Time Frame
Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Title
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
Description
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.
Time Frame
Week 0, Week 14, Week 30, Week 54
Title
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Time Frame
Week 0, Week 14, Week 30, Week 54
Title
The Number of Improved Intestinal BD Patients From Baseline
Description
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.
Time Frame
Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Title
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Description
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".
Time Frame
Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Title
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Description
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".
Time Frame
Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiaki Ishigatsubo, MD, Ph.D
Organizational Affiliation
Yokohama City University Graduate School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Toshifumi Hibi, MD
Organizational Affiliation
Kitasato University Kitasato Institute Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shunsei Hirohata, MD
Organizational Affiliation
Kitasato University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubihsi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Chubu
Country
Japan
Facility Name
Investigational site
City
Hokkaido
Country
Japan
Facility Name
Investigational site
City
Kanto
Country
Japan
Facility Name
Investigational site
City
Kinki
Country
Japan
Facility Name
Investigational site
City
Kyusyu
Country
Japan
Facility Name
Investigational site
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27310969
Citation
Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, Kondo K, Ishigatsubo Y. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study. Medicine (Baltimore). 2016 Jun;95(24):e3863. doi: 10.1097/MD.0000000000003863. Erratum In: Medicine (Baltimore). 2016 Aug 07;95(31):e5074.
Results Reference
result

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

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