Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01532570
Recruitment Status : Completed
First Posted : February 14, 2012
Results First Posted : December 16, 2016
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Behcet's Disease
Behcet Syndrome
Neuro-Behcet's Disease
Intervention Drug: TA-650
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intestinal BD Acute Neuro-BD Chronic Progressive Neuro-BD Vascular BD
Hide Arm/Group Description A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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. A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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. A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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. A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Period Title: Overall Study
Started 11 2 1 4
Completed 10 1 1 4
Not Completed 1 1 0 0
Reason Not Completed
Lack of Efficacy             1             0             0             0
Withdrawal by Subject             0             1             0             0
Arm/Group Title Intestinal BD Acute Neuro-BD Chronic Progressive Neuro-BD Vascular BD Total
Hide Arm/Group Description A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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. A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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. A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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. A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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. Total of all reporting groups
Overall Number of Baseline Participants 11 2 1 4 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 2 participants 1 participants 4 participants 18 participants
35.0  (13.4) 34.0  (5.7) 47.0 [1]   (NA) 44.0  (2.9) 37.6  (11.4)
[1]
There is no data because the Overall Number of Baseline Participant is 1.
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 2 participants 1 participants 4 participants 18 participants
Female
6
  54.5%
1
  50.0%
0
   0.0%
1
  25.0%
8
  44.4%
Male
5
  45.5%
1
  50.0%
1
 100.0%
3
  75.0%
10
  55.6%
1.Primary Outcome
Title Percentage of Participants With Complete Response at Week 30
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intestinal BD Acute Neuro-BD Chronic Progressive Neuro-BD Vascular BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 11 2 1 4
Measure Type: Number
Unit of Measure: percentage of Complete Responders
54.5 0 100 100
2.Secondary Outcome
Title Percentage of Participants With Complete Response at Week 14 and 54
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intestinal BD Acute Neuro-BD Chronic Progressive Neuro-BD Vascular BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 11 2 1 4
Measure Type: Number
Unit of Measure: percentage of Complete Responders
Week 14 (n=11, 2, 1, 4) 54.5 0 100 100
Week 54 (n=10, 1, 1, 4) 60 0 100 100
3.Secondary Outcome
Title Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intestinal BD Neuro-BD (Acute+Chronic Progressive) Vascular BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.

Acute; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.

Chronic Progressive; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.

A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 11 3 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 (n=11, 3, 4) 55.5  (22.9) 41.3  (11.0) 40.5  (34.4)
Week 2 (n=11, 3, 4) 42.7  (30.9) 33.0  (23.1) 11.8  (7.8)
Week 6 (n=11, 3, 4) 26.4  (20.3) 15.0  (17.1) 14.3  (8.1)
Week 10 (n=11, 3, 4) 23.6  (19.8) 23.0  (20.4) 17.8  (14.0)
Week 14 (n=11, 3, 4) 32.4  (24.0) 28.3  (30.0) 13.5  (9.8)
Week 18 (n=11, 3, 4) 23.9  (20.8) 31.7  (22.4) 15.3  (8.9)
Week 22 (n=11, 3, 4) 31.8  (26.0) 35.3  (31.5) 17.8  (6.4)
Week 26 (n=11, 2, 4) 28.9  (20.7) 18.5  (23.3) 17.5  (9.8)
Week 30 (n=11, 2, 4) 31.1  (29.2) 15.0  (21.2) 11.8  (7.5)
Week 34 (n=11, 2, 4) 21.2  (21.6) 12.5  (17.7) 18.8  (9.2)
Week 38 (n=11, 2, 4) 25.4  (30.8) 11.5  (16.3) 10.3  (8.3)
Week 42 (n=10, 2, 4) 20.9  (20.4) 13.0  (18.4) 13.5  (9.3)
Week 46 (n=10, 2, 4) 22.3  (27.5) 11.5  (16.3) 10.5  (6.6)
Week 50 (n=10, 2, 4) 17.5  (25.1) 11.5  (16.3) 22.8  (25.4)
Week 54 (n=10, 2, 4) 21.0  (26.6) 8.5  (12.0) 11.3  (7.9)
Final (n=11, 3, 4) 26.9  (29.6) 7.7  (8.6) 11.3  (7.9)
4.Secondary Outcome
Title Imaging Findings:Endoscopic Examination for Intestinal BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intestinal BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
The ulcer was cured or scarred: Week 14 (n=11) 9
Reduced to = < 1/4: Week 14 (n=11) 0
Reduced to > 1/4 to = < 1/2: Week 14 (n=11) 0
Reduced to > 1/2 or increase: Week 14 (n=11) 2
The ulcer was cured or scarred: Week 30 (n=11) 9
Reduced to = < 1/4: Week 30 (n=11) 0
Reduced to > 1/4 to = < 1/2: Week 30 (n=11) 0
Reduced to > 1/2 or increase: Week 30 (n=11) 2
The ulcer was cured or scarred: Week 54 (n=9) 8
Reduced to = < 1/4: Week 54 (n=9) 0
Reduced to > 1/4 to = < 1/2: Week 54 (n=9) 0
Reduced to > 1/2 or increase: Week 54 (n=9) 1
The ulcer was cured or scarred: Final (n=11) 9
Reduced to = < 1/4: Final (n=11) 0
Reduced to > 1/4 to = < 1/2: Final (n=11) 0
Reduced to > 1/2 or increase: Final (n=11) 2
5.Secondary Outcome
Title Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Neuro-BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Reduced high intensity areas, Week 14 (n=2) 2
Reduced high intensity areas, Week 30 (n=1) 1
Reduced high intensity areas, Week 54 (n=1) 1
6.Secondary Outcome
Title Imaging Findings: Brainstem MRI for Chronic Neuro-BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chronic Progressive Neuro-BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
Unchanged brain stem area, Week 14 1
Unchanged brain stem area, Week 30 1
Unchanged brain stem area, Week 54 1
7.Secondary Outcome
Title Imaging Findings: CT, PET/CT for Vascular-BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vascular-BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
Improved, Week 14 3
Unchanged, Week 14 1
Woesened, Week 14 0
Improved, Week 30 3
Unchanged, Week 30 1
Worsened, Week 30 0
Improved, Week 54 3
Unchanged, Week 54 1
Worsened, Week 54 0
8.Secondary Outcome
Title Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intestinal BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 11
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Week 0 (n=11)
0.20
(0.00 to 1.00)
Week 2 (n=11)
0.00
(0.00 to 0.00)
Week 6 (n=11)
0.10
(0.00 to 0.10)
Week 10 (n=11)
0.10
(0.00 to 0.30)
Week 14 (n=10)
0.15
(0.00 to 0.80)
Week 18 (n=11)
0.10
(0.00 to 0.10)
Week 22 (n=11)
0.10
(0.00 to 0.50)
Week 26 (n=11)
0.00
(0.00 to 0.10)
Week 30 (n=11)
0.10
(0.00 to 2.20)
Week 34 (n=11)
0.00
(0.00 to 0.30)
Week 38 (n=11)
0.10
(0.00 to 0.60)
Week 42 (n=10)
0.00
(0.00 to 0.20)
Week 46 (n=10)
0.00
(0.00 to 0.10)
Week 50 (n=10)
0.05
(0.00 to 0.10)
Week 54 (n=10)
0.10
(0.00 to 0.20)
Final (n=11)
0.10
(0.00 to 0.20)
9.Secondary Outcome
Title Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vascular-BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 4
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Week 0
0.90
(0.55 to 2.65)
Week 2
0.25
(0.10 to 0.35)
Week 6
0.20
(0.05 to 0.30)
Week 10
0.10
(0.05 to 0.10)
Week 14
0.15
(0.10 to 0.30)
Week 18
0.15
(0.10 to 0.25)
Week 22
0.10
(0.10 to 0.10)
Week 26
0.10
(0.10 to 0.15)
Week 30
0.10
(0.05 to 0.15)
Week 34
0.10
(0.05 to 0.25)
Week 38
0.15
(0.10 to 0.85)
Week 42
0.10
(0.10 to 0.15)
Week 46
0.15
(0.10 to 0.20)
Week 50
0.05
(0.00 to 1.05)
Week 54
0.15
(0.05 to 0.20)
Final
0.15
(0.05 to 0.20)
10.Secondary Outcome
Title Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vascular-BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 4
Median (Inter-Quartile Range)
Unit of Measure: mm/hr
Week 0
31.0
(21.5 to 35.5)
Week 2
11.0
(7.0 to 14.5)
Week 6
8.0
(3.0 to 12.5)
Week 10
7.0
(3.0 to 11.0)
Week 14
8.5
(3.5 to 13.0)
Week 18
6.5
(3.0 to 11.0)
Week 22
5.5
(3.0 to 11.0)
Week 26
7.5
(2.5 to 11.0)
Week 30
4.5
(4.0 to 9.5)
Week 34
6.5
(2.5 to 13.0)
Week 38
9.0
(5.0 to 11.0)
Week 42
9.5
(5.5 to 11.0)
Week 46
8.5
(4.5 to 10.5)
Week 50
8.0
(5.0 to 10.5)
Week 54
6.5
(3.0 to 9.0)
Final
6.5
(3.0 to 9.0)
11.Secondary Outcome
Title Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Neuro BD (Patient 1) Acute Neuro-BD (Patient 2)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: cells/mL
Week 0 37 3
Week 14 4 2
Week 30 1 NA [1] 
Week 54 NA [2]  NA [1] 
At discontinuation NA [3]  2
[1]
There is no data because of discontinuation
[2]
The value is Limit of Quantification (LOQ)) (i.e. =<1)
[3]
There is no data because of completion
12.Secondary Outcome
Title Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Hide Description [Not Specified]
Time Frame Week 0, Week 14, Week 30, Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Neuro BD (Patient No.1) Acute Neuro-BD (Patient No.2) Chronic Progressive Neuro-BD
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: pg/mL
Week 0 145 2.5 64.5
Week 14 2.2 23 35.1
Week 30 1.4 NA [1]  5.4
Week 54 1.5 NA [1]  32.1
At discontinuation NA [2]  6.5 NA [2] 
[1]
There is no data because of discontinuation
[2]
There is no data because of completion
13.Secondary Outcome
Title The Number of Improved Intestinal BD Patients From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intestinal BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
Week 2 (n=11) 7
Week 6 (n=11) 9
Week 10 (n=11) 9
Week 14 (n=11) 8
Week 18 (n=11) 11
Week 22 (n=11) 10
Week 26 (n=11) 10
Week 30 (n=11) 10
Week 34 (n=11) 10
Week 38 (n=11) 9
Week 42 (n=10) 8
Week 46 (n=10) 8
Week 50 (n=10) 8
Week 54 (n=10) 8
Final (n=11) 9
14.Secondary Outcome
Title Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Neuro BD (Patient No.1) Acute Neuro-BD (Patient No.2) Chronic Progressive Neuro-BD
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: participants
No symptom, Week 2 1 1 0
Improved, Week 2 0 0 0
Unchanged, Week 2 0 0 1
Worsened, Week 2 0 0 0
No symptom, Week 6 1 1 1
Improved, Week 6 0 0 0
Unchanged, Week 6 0 0 0
Worsened, Week 6 0 0 0
No symptom, Week 10 1 0 0
Improved, Week 10 0 1 1
Unchanged, Week 10 0 0 0
Worsened, Week 10 0 0 0
No symptom, Week 14 1 0 1
Improved, Week 14 0 1 0
Unchanged, Week 14 0 0 0
Worsened, Week 14 0 0 0
No symptom, Week 18 1 0 1
Improved, Week 18 0 1 0
Unchanged, Week 18 0 0 0
Worsened, Week 18 0 0 0
No symptom, Week 22 0 0 1
Improved, Week 22 1 0 0
Unchanged, Week 22 0 1 0
Worsened, Week 22 0 0 0
No symptom, Week 26 1 NA [1]  1
Improved, Week 26 0 NA [1]  0
Unchanged, Week 26 0 NA [1]  0
Worsened, Week 26 0 NA [1]  0
No symptom, Week 30 1 NA [1]  1
Improved, Week 30 0 NA [1]  0
Unchanged, Week 30 0 NA [1]  0
Worsened, Week 30 0 NA [1]  0
No symptom, Week 34 1 NA [1]  1
Improved, Week 34 0 NA [1]  0
Unchanged, Week 34 0 NA [1]  0
Worsened, Week 34 0 NA [1]  0
No symptom, Week 38 1 NA [1]  1
Improved, Week 38 0 NA [1]  0
Unchanged, Week 38 0 NA [1]  0
Worsened, Week 38 0 NA [1]  0
No symptom, Week 42 1 NA [1]  1
Improved, Week 42 0 NA [1]  0
Unchanged, Week 42 0 NA [1]  0
Worsened, Week 42 0 NA [1]  0
No symptom, Week 46 1 NA [1]  1
Improved, Week 46 0 NA [1]  0
Unchanged, Week 46 0 NA [1]  0
Worsened, Week 46 0 NA [1]  0
No symptom, Week 50 1 NA [1]  1
Improved, Week 50 0 NA [1]  0
Unchanged, Week 50 0 NA [1]  0
Worsened, Week 50 0 NA [1]  0
No symptom, Week 54 1 NA [1]  1
Improved, Week 54 0 NA [1]  0
Unchanged, Week 54 0 NA [1]  0
Worsened, Week 54 0 NA [1]  0
No symptom, at discontinuations NA [2]  1 NA [2] 
Improved, at discontinuations NA [2]  0 NA [2] 
Unchanged, at discontinuations NA [2]  0 NA [2] 
Worsened, at discontinuations NA [2]  0 NA [2] 
[1]
There is no data because of discontinuation
[2]
There is no data because of completion
15.Secondary Outcome
Title Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vascular-BD
Hide Arm/Group Description:
A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. 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.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
No symptom, Week 2 1
Improved, Week 2 2
Unchanged, Week 2 1
Worsened, Week 2 0
No symptom, Week 6 1
Improved, Week 6 2
Unchanged, Week 6 1
Worsened, Week 6 0
No symptom, Week 10 1
Improved, Week 10 2
Unchanged, Week 10 1
Worsened, Week 10 0
No symptom, Week 14 1
Improved, Week 14 2
Unchanged, Week 14 1
Worsened, Week 14 0
No symptom, Week 18 0
Improved, Week 18 4
Unchanged, Week 18 0
Worsened, Week 18 0
No symptom, Week 22 0
Improved, Week 22 3
Unchanged, Week 22 1
Worsened, Week 22 0
No symptom, Week 26 0
Improved, Week 26 3
Unchanged, Week 26 1
Worsened, Week 26 0
No symptom, Week 30 0
Improved, Week 30 4
Unchanged, Week 30 0
Worsened, Week 30 0
No symptom, Week 34 0
Improved, Week 34 3
Unchanged, Week 34 1
Worsened, Week 34 0
No symptom, Week 38 0
Improved, Week 38 4
Unchanged, Week 38 0
Worsened, Week 38 0
No symptom, Week 42 0
Improved, Week 42 4
Unchanged, Week 42 0
Worsened, Week 42 0
No symptom, Week 46 0
Improved, Week 46 4
Unchanged, Week 46 0
Worsened, Week 46 0
No symptom, Week 50 0
Improved, Week 50 4
Unchanged, Week 50 0
Worsened, Week 50 0
No symptom, Week 54 0
Improved, Week 54 4
Unchanged, Week 54 0
Worsened, Week 54 0
No symptom, Final 0
Improved, Final 4
Unchanged, Final 0
Worsened, Final 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TA-650
Hide Arm/Group Description TA-650: 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.
All-Cause Mortality
TA-650
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TA-650
Affected / at Risk (%)
Total   2/18 (11.11%) 
Eye disorders   
Cataract  1/18 (5.56%) 
Vascular disorders   
Behcet's syndrome  1/18 (5.56%) 
1
Term from vocabulary, MedDRA/J 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TA-650
Affected / at Risk (%)
Total   17/18 (94.44%) 
Cardiac disorders   
Palpitations  1/18 (5.56%) 
Eye disorders   
Conjunctival haemorrhage  1/18 (5.56%) 
Dry eye  1/18 (5.56%) 
Gastrointestinal disorders   
Constipation  1/18 (5.56%) 
Gastritis  1/18 (5.56%) 
Nausea  1/18 (5.56%) 
Proctalgia  2/18 (11.11%) 
General disorders   
Malaise  1/18 (5.56%) 
Puncture site reaction  1/18 (5.56%) 
Pyrexia  2/18 (11.11%) 
Hepatobiliary disorders   
Cholelithiasis  1/18 (5.56%) 
Liver disorder  1/18 (5.56%) 
Infections and infestations   
Bronchitis  1/18 (5.56%) 
Enteritis infectious  2/18 (11.11%) 
Gastroenteritis  2/18 (11.11%) 
Gastroenteritis norovirus  1/18 (5.56%) 
Influenza  1/18 (5.56%) 
Nasopharyngitis  4/18 (22.22%) 
Periodontitis  1/18 (5.56%) 
Pharyngitis  1/18 (5.56%) 
Pulpitis dental  1/18 (5.56%) 
Tinea pedis  1/18 (5.56%) 
Tonsillitis  1/18 (5.56%) 
Upper respiratory tract infection  5/18 (27.78%) 
Injury, poisoning and procedural complications   
Administration related reaction  1/18 (5.56%) 
Arthropod sting  1/18 (5.56%) 
Contusion  1/18 (5.56%) 
Excoriation  1/18 (5.56%) 
Ligament sprain  2/18 (11.11%) 
Limb injury  1/18 (5.56%) 
Post lumbar puncture syndrome  1/18 (5.56%) 
Tongue injury  1/18 (5.56%) 
Wound  1/18 (5.56%) 
Investigations   
Antinuclear antibody increased  2/18 (11.11%) 
Double stranded DNA antibody positive  8/18 (44.44%) 
White blood cell count decreased  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  2/18 (11.11%) 
Back pain  2/18 (11.11%) 
Muscle rigidity  1/18 (5.56%) 
Myalgia  1/18 (5.56%) 
Tenosynovitis  1/18 (5.56%) 
Nervous system disorders   
Dizziness  1/18 (5.56%) 
Dysaesthesia  1/18 (5.56%) 
Headache  2/18 (11.11%) 
Hypoaesthesia  1/18 (5.56%) 
Intracranial hypotension  1/18 (5.56%) 
Somnolence  1/18 (5.56%) 
Tension headache  1/18 (5.56%) 
Psychiatric disorders   
Depressive symptom  1/18 (5.56%) 
Somatoform disorder  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1/18 (5.56%) 
Epistaxis  1/18 (5.56%) 
Upper respiratory tract inflammation  1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
Acne  2/18 (11.11%) 
Asteatosis  1/18 (5.56%) 
Dermatitis acneiform  1/18 (5.56%) 
Dermatitis contact  1/18 (5.56%) 
Drug eruption  1/18 (5.56%) 
Dyshidrotic eczema  1/18 (5.56%) 
Rash  1/18 (5.56%) 
Urticaria  1/18 (5.56%) 
Vascular disorders   
Behcet's syndrome  1/18 (5.56%) 
1
Term from vocabulary, MedDRA/J 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
EMail: cti-inq-ml@ml.mt-pharma.co.jp
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01532570     History of Changes
Other Study ID Numbers: TA-650-23
First Submitted: February 6, 2012
First Posted: February 14, 2012
Results First Submitted: June 15, 2016
Results First Posted: December 16, 2016
Last Update Posted: December 16, 2016