Trial Outcomes & Findings for Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions (NCT NCT01532570)
NCT ID: NCT01532570
Last Updated: 2016-12-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
18 participants
Primary outcome timeframe
Week 30
Results posted on
2016-12-16
Participant Flow
Participant milestones
| Measure |
Intestinal BD
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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 Study
STARTED
|
11
|
2
|
1
|
4
|
|
Overall Study
COMPLETED
|
10
|
1
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Intestinal BD
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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 Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
Baseline characteristics by cohort
| Measure |
Intestinal BD
n=11 Participants
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 Neuro-BD
n=2 Participants
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 Neuro-BD
n=1 Participants
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.
|
Vascular BD
n=4 Participants
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
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.0 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 2.9 • n=4 Participants
|
37.6 years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 30We 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.
Outcome measures
| Measure |
Intestinal BD
n=11 Participants
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 Neuro-BD
n=2 Participants
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 Neuro-BD
n=1 Participants
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.
|
Vascular BD
n=4 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Response at Week 30
|
54.5 percentage of Complete Responders
|
0 percentage of Complete Responders
|
100 percentage of Complete Responders
|
100 percentage of Complete Responders
|
SECONDARY outcome
Timeframe: Week 14, Week 54We 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.
Outcome measures
| Measure |
Intestinal BD
n=11 Participants
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 Neuro-BD
n=2 Participants
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 Neuro-BD
n=1 Participants
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.
|
Vascular BD
n=4 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Response at Week 14 and 54
Week 54 (n=10, 1, 1, 4)
|
60 percentage of Complete Responders
|
0 percentage of Complete Responders
|
100 percentage of Complete Responders
|
100 percentage of Complete Responders
|
|
Percentage of Participants With Complete Response at Week 14 and 54
Week 14 (n=11, 2, 1, 4)
|
54.5 percentage of Complete Responders
|
0 percentage of Complete Responders
|
100 percentage of Complete Responders
|
100 percentage of Complete Responders
|
SECONDARY outcome
Timeframe: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54The 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.
Outcome measures
| Measure |
Intestinal BD
n=11 Participants
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 Neuro-BD
n=3 Participants
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 Neuro-BD
n=4 Participants
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 0 (n=11, 3, 4)
|
55.5 units on a scale
Standard Deviation 22.9
|
41.3 units on a scale
Standard Deviation 11.0
|
40.5 units on a scale
Standard Deviation 34.4
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 2 (n=11, 3, 4)
|
42.7 units on a scale
Standard Deviation 30.9
|
33.0 units on a scale
Standard Deviation 23.1
|
11.8 units on a scale
Standard Deviation 7.8
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 6 (n=11, 3, 4)
|
26.4 units on a scale
Standard Deviation 20.3
|
15.0 units on a scale
Standard Deviation 17.1
|
14.3 units on a scale
Standard Deviation 8.1
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 10 (n=11, 3, 4)
|
23.6 units on a scale
Standard Deviation 19.8
|
23.0 units on a scale
Standard Deviation 20.4
|
17.8 units on a scale
Standard Deviation 14.0
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 14 (n=11, 3, 4)
|
32.4 units on a scale
Standard Deviation 24.0
|
28.3 units on a scale
Standard Deviation 30.0
|
13.5 units on a scale
Standard Deviation 9.8
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 18 (n=11, 3, 4)
|
23.9 units on a scale
Standard Deviation 20.8
|
31.7 units on a scale
Standard Deviation 22.4
|
15.3 units on a scale
Standard Deviation 8.9
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 22 (n=11, 3, 4)
|
31.8 units on a scale
Standard Deviation 26.0
|
35.3 units on a scale
Standard Deviation 31.5
|
17.8 units on a scale
Standard Deviation 6.4
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 26 (n=11, 2, 4)
|
28.9 units on a scale
Standard Deviation 20.7
|
18.5 units on a scale
Standard Deviation 23.3
|
17.5 units on a scale
Standard Deviation 9.8
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 30 (n=11, 2, 4)
|
31.1 units on a scale
Standard Deviation 29.2
|
15.0 units on a scale
Standard Deviation 21.2
|
11.8 units on a scale
Standard Deviation 7.5
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 34 (n=11, 2, 4)
|
21.2 units on a scale
Standard Deviation 21.6
|
12.5 units on a scale
Standard Deviation 17.7
|
18.8 units on a scale
Standard Deviation 9.2
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 38 (n=11, 2, 4)
|
25.4 units on a scale
Standard Deviation 30.8
|
11.5 units on a scale
Standard Deviation 16.3
|
10.3 units on a scale
Standard Deviation 8.3
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 42 (n=10, 2, 4)
|
20.9 units on a scale
Standard Deviation 20.4
|
13.0 units on a scale
Standard Deviation 18.4
|
13.5 units on a scale
Standard Deviation 9.3
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 46 (n=10, 2, 4)
|
22.3 units on a scale
Standard Deviation 27.5
|
11.5 units on a scale
Standard Deviation 16.3
|
10.5 units on a scale
Standard Deviation 6.6
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 50 (n=10, 2, 4)
|
17.5 units on a scale
Standard Deviation 25.1
|
11.5 units on a scale
Standard Deviation 16.3
|
22.8 units on a scale
Standard Deviation 25.4
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Week 54 (n=10, 2, 4)
|
21.0 units on a scale
Standard Deviation 26.6
|
8.5 units on a scale
Standard Deviation 12.0
|
11.3 units on a scale
Standard Deviation 7.9
|
—
|
|
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
Final (n=11, 3, 4)
|
26.9 units on a scale
Standard Deviation 29.6
|
7.7 units on a scale
Standard Deviation 8.6
|
11.3 units on a scale
Standard Deviation 7.9
|
—
|
SECONDARY outcome
Timeframe: Week 14, Week 30, Week 54The 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.
Outcome measures
| Measure |
Intestinal BD
n=11 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
The ulcer was cured or scarred: Week 14 (n=11)
|
9 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to = < 1/4: Week 14 (n=11)
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to > 1/4 to = < 1/2: Week 14 (n=11)
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to > 1/2 or increase: Week 14 (n=11)
|
2 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
The ulcer was cured or scarred: Week 30 (n=11)
|
9 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to = < 1/4: Week 30 (n=11)
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to > 1/4 to = < 1/2: Week 30 (n=11)
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to > 1/2 or increase: Week 30 (n=11)
|
2 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
The ulcer was cured or scarred: Week 54 (n=9)
|
8 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to = < 1/4: Week 54 (n=9)
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to > 1/4 to = < 1/2: Week 54 (n=9)
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to > 1/2 or increase: Week 54 (n=9)
|
1 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
The ulcer was cured or scarred: Final (n=11)
|
9 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to = < 1/4: Final (n=11)
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to > 1/4 to = < 1/2: Final (n=11)
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings:Endoscopic Examination for Intestinal BD
Reduced to > 1/2 or increase: Final (n=11)
|
2 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14, Week 30, Week 54Changes 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.
Outcome measures
| Measure |
Intestinal BD
n=2 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
Reduced high intensity areas, Week 14 (n=2)
|
2 participants
|
—
|
—
|
—
|
|
Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
Reduced high intensity areas, Week 30 (n=1)
|
1 participants
|
—
|
—
|
—
|
|
Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
Reduced high intensity areas, Week 54 (n=1)
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14, Week 30, Week 54Changes 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.
Outcome measures
| Measure |
Intestinal BD
n=1 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Imaging Findings: Brainstem MRI for Chronic Neuro-BD
Unchanged brain stem area, Week 14
|
1 participants
|
—
|
—
|
—
|
|
Imaging Findings: Brainstem MRI for Chronic Neuro-BD
Unchanged brain stem area, Week 30
|
1 participants
|
—
|
—
|
—
|
|
Imaging Findings: Brainstem MRI for Chronic Neuro-BD
Unchanged brain stem area, Week 54
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14, Week 30, Week 54Changes 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.
Outcome measures
| Measure |
Intestinal BD
n=4 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Improved, Week 14
|
3 participants
|
—
|
—
|
—
|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Unchanged, Week 14
|
1 participants
|
—
|
—
|
—
|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Woesened, Week 14
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Improved, Week 30
|
3 participants
|
—
|
—
|
—
|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Unchanged, Week 30
|
1 participants
|
—
|
—
|
—
|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Worsened, Week 30
|
0 participants
|
—
|
—
|
—
|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Improved, Week 54
|
3 participants
|
—
|
—
|
—
|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Unchanged, Week 54
|
1 participants
|
—
|
—
|
—
|
|
Imaging Findings: CT, PET/CT for Vascular-BD
Worsened, Week 54
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54The 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.
Outcome measures
| Measure |
Intestinal BD
n=11 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 0 (n=11)
|
0.20 mg/dL
Interval 0.0 to 1.0
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 2 (n=11)
|
0.00 mg/dL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 6 (n=11)
|
0.10 mg/dL
Interval 0.0 to 0.1
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 10 (n=11)
|
0.10 mg/dL
Interval 0.0 to 0.3
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 14 (n=10)
|
0.15 mg/dL
Interval 0.0 to 0.8
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 18 (n=11)
|
0.10 mg/dL
Interval 0.0 to 0.1
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 22 (n=11)
|
0.10 mg/dL
Interval 0.0 to 0.5
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 26 (n=11)
|
0.00 mg/dL
Interval 0.0 to 0.1
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 30 (n=11)
|
0.10 mg/dL
Interval 0.0 to 2.2
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 34 (n=11)
|
0.00 mg/dL
Interval 0.0 to 0.3
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 38 (n=11)
|
0.10 mg/dL
Interval 0.0 to 0.6
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 42 (n=10)
|
0.00 mg/dL
Interval 0.0 to 0.2
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 46 (n=10)
|
0.00 mg/dL
Interval 0.0 to 0.1
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 50 (n=10)
|
0.05 mg/dL
Interval 0.0 to 0.1
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Week 54 (n=10)
|
0.10 mg/dL
Interval 0.0 to 0.2
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
Final (n=11)
|
0.10 mg/dL
Interval 0.0 to 0.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54The 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.
Outcome measures
| Measure |
Intestinal BD
n=4 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 0
|
0.90 mg/dL
Interval 0.55 to 2.65
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 2
|
0.25 mg/dL
Interval 0.1 to 0.35
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 6
|
0.20 mg/dL
Interval 0.05 to 0.3
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 10
|
0.10 mg/dL
Interval 0.05 to 0.1
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 14
|
0.15 mg/dL
Interval 0.1 to 0.3
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 18
|
0.15 mg/dL
Interval 0.1 to 0.25
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 22
|
0.10 mg/dL
Interval 0.1 to 0.1
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 26
|
0.10 mg/dL
Interval 0.1 to 0.15
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 30
|
0.10 mg/dL
Interval 0.05 to 0.15
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 34
|
0.10 mg/dL
Interval 0.05 to 0.25
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 38
|
0.15 mg/dL
Interval 0.1 to 0.85
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 42
|
0.10 mg/dL
Interval 0.1 to 0.15
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 46
|
0.15 mg/dL
Interval 0.1 to 0.2
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 50
|
0.05 mg/dL
Interval 0.0 to 1.05
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Week 54
|
0.15 mg/dL
Interval 0.05 to 0.2
|
—
|
—
|
—
|
|
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
Final
|
0.15 mg/dL
Interval 0.05 to 0.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54The 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.
Outcome measures
| Measure |
Intestinal BD
n=4 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 0
|
31.0 mm/hr
Interval 21.5 to 35.5
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 2
|
11.0 mm/hr
Interval 7.0 to 14.5
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 6
|
8.0 mm/hr
Interval 3.0 to 12.5
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 10
|
7.0 mm/hr
Interval 3.0 to 11.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 14
|
8.5 mm/hr
Interval 3.5 to 13.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 18
|
6.5 mm/hr
Interval 3.0 to 11.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 22
|
5.5 mm/hr
Interval 3.0 to 11.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 26
|
7.5 mm/hr
Interval 2.5 to 11.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 30
|
4.5 mm/hr
Interval 4.0 to 9.5
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 34
|
6.5 mm/hr
Interval 2.5 to 13.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 38
|
9.0 mm/hr
Interval 5.0 to 11.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 42
|
9.5 mm/hr
Interval 5.5 to 11.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 46
|
8.5 mm/hr
Interval 4.5 to 10.5
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 50
|
8.0 mm/hr
Interval 5.0 to 10.5
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Week 54
|
6.5 mm/hr
Interval 3.0 to 9.0
|
—
|
—
|
—
|
|
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
Final
|
6.5 mm/hr
Interval 3.0 to 9.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 14, Week 30, Week 54The 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.
Outcome measures
| Measure |
Intestinal BD
n=1 Participants
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 Neuro-BD
n=1 Participants
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
At discontinuation
|
NA cells/mL
There is no data because of completion
|
2 cells/mL
|
—
|
—
|
|
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
Week 0
|
37 cells/mL
|
3 cells/mL
|
—
|
—
|
|
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
Week 14
|
4 cells/mL
|
2 cells/mL
|
—
|
—
|
|
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
Week 30
|
1 cells/mL
|
NA cells/mL
There is no data because of discontinuation
|
—
|
—
|
|
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
Week 54
|
NA cells/mL
The value is Limit of Quantification (LOQ)) (i.e. =\<1)
|
NA cells/mL
There is no data because of discontinuation
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 14, Week 30, Week 54Outcome measures
| Measure |
Intestinal BD
n=1 Participants
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 Neuro-BD
n=1 Participants
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 Neuro-BD
n=1 Participants
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Week 0
|
145 pg/mL
|
2.5 pg/mL
|
64.5 pg/mL
|
—
|
|
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Week 14
|
2.2 pg/mL
|
23 pg/mL
|
35.1 pg/mL
|
—
|
|
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Week 30
|
1.4 pg/mL
|
NA pg/mL
There is no data because of discontinuation
|
5.4 pg/mL
|
—
|
|
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Week 54
|
1.5 pg/mL
|
NA pg/mL
There is no data because of discontinuation
|
32.1 pg/mL
|
—
|
|
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
At discontinuation
|
NA pg/mL
There is no data because of completion
|
6.5 pg/mL
|
NA pg/mL
There is no data because of completion
|
—
|
SECONDARY outcome
Timeframe: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54The 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.
Outcome measures
| Measure |
Intestinal BD
n=11 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 2 (n=11)
|
7 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 6 (n=11)
|
9 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 10 (n=11)
|
9 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 14 (n=11)
|
8 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 18 (n=11)
|
11 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 22 (n=11)
|
10 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 26 (n=11)
|
10 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 30 (n=11)
|
10 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 34 (n=11)
|
10 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 38 (n=11)
|
9 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 42 (n=10)
|
8 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 46 (n=10)
|
8 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 50 (n=10)
|
8 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Week 54 (n=10)
|
8 participants
|
—
|
—
|
—
|
|
The Number of Improved Intestinal BD Patients From Baseline
Final (n=11)
|
9 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54The 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".
Outcome measures
| Measure |
Intestinal BD
n=1 Participants
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 Neuro-BD
n=1 Participants
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 Neuro-BD
n=1 Participants
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 2
|
1 participants
|
1 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 2
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 2
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 2
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 6
|
1 participants
|
1 participants
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 6
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 6
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 6
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 10
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 10
|
0 participants
|
1 participants
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 10
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 10
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 14
|
1 participants
|
0 participants
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 14
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 14
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 14
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 18
|
1 participants
|
0 participants
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 18
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 18
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 18
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 22
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 22
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 22
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 22
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 26
|
1 participants
|
NA participants
There is no data because of discontinuation
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 26
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 26
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 26
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 30
|
1 participants
|
NA participants
There is no data because of discontinuation
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 30
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 30
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 30
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 34
|
1 participants
|
NA participants
There is no data because of discontinuation
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 34
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 34
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 34
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 38
|
1 participants
|
NA participants
There is no data because of discontinuation
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 38
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 38
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 38
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 42
|
1 participants
|
NA participants
There is no data because of discontinuation
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 42
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 42
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 42
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 46
|
1 participants
|
NA participants
There is no data because of discontinuation
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 46
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 46
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 46
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 50
|
1 participants
|
NA participants
There is no data because of discontinuation
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 50
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 50
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 50
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, Week 54
|
1 participants
|
NA participants
There is no data because of discontinuation
|
1 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, Week 54
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, Week 54
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, Week 54
|
0 participants
|
NA participants
There is no data because of discontinuation
|
0 participants
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
No symptom, at discontinuations
|
NA participants
There is no data because of completion
|
1 participants
|
NA participants
There is no data because of completion
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Improved, at discontinuations
|
NA participants
There is no data because of completion
|
0 participants
|
NA participants
There is no data because of completion
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Unchanged, at discontinuations
|
NA participants
There is no data because of completion
|
0 participants
|
NA participants
There is no data because of completion
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
Worsened, at discontinuations
|
NA participants
There is no data because of completion
|
0 participants
|
NA participants
There is no data because of completion
|
—
|
SECONDARY outcome
Timeframe: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54The 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".
Outcome measures
| Measure |
Intestinal BD
n=4 Participants
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 Neuro-BD
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 Neuro-BD
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.
|
Vascular BD
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.
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 2
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 2
|
2 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 2
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 2
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 6
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 6
|
2 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 6
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 6
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 10
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 10
|
2 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 10
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 10
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 14
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 14
|
2 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 14
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 14
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 18
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 18
|
4 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 18
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 18
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 22
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 22
|
3 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 22
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 22
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 26
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 26
|
3 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 26
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 26
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 30
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 30
|
4 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 30
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 30
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 34
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 34
|
3 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 34
|
1 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 34
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 38
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 38
|
4 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 38
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 38
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 42
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 42
|
4 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 42
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 42
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 46
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 46
|
4 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 46
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 46
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 50
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 50
|
4 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 50
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 50
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Week 54
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Week 54
|
4 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Week 54
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Week 54
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
No symptom, Final
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Improved, Final
|
4 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Unchanged, Final
|
0 participants
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
Worsened, Final
|
0 participants
|
—
|
—
|
—
|
Adverse Events
TA-650
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-650
n=18 participants at risk
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.
|
|---|---|
|
Eye disorders
Cataract
|
5.6%
1/18
|
|
Vascular disorders
Behcet's syndrome
|
5.6%
1/18
|
Other adverse events
| Measure |
TA-650
n=18 participants at risk
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.
|
|---|---|
|
Infections and infestations
Bronchitis
|
5.6%
1/18
|
|
Infections and infestations
Enteritis infectious
|
11.1%
2/18
|
|
Infections and infestations
Gastroenteritis
|
11.1%
2/18
|
|
Infections and infestations
Gastroenteritis norovirus
|
5.6%
1/18
|
|
Infections and infestations
Influenza
|
5.6%
1/18
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
4/18
|
|
Infections and infestations
Periodontitis
|
5.6%
1/18
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18
|
|
Infections and infestations
Pulpitis dental
|
5.6%
1/18
|
|
Infections and infestations
Tinea pedis
|
5.6%
1/18
|
|
Infections and infestations
Tonsillitis
|
5.6%
1/18
|
|
Infections and infestations
Upper respiratory tract infection
|
27.8%
5/18
|
|
Psychiatric disorders
Depressive symptom
|
5.6%
1/18
|
|
Psychiatric disorders
Somatoform disorder
|
5.6%
1/18
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18
|
|
Nervous system disorders
Dysaesthesia
|
5.6%
1/18
|
|
Nervous system disorders
Headache
|
11.1%
2/18
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
1/18
|
|
Nervous system disorders
Intracranial hypotension
|
5.6%
1/18
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18
|
|
Nervous system disorders
Tension headache
|
5.6%
1/18
|
|
Eye disorders
Conjunctival haemorrhage
|
5.6%
1/18
|
|
Eye disorders
Dry eye
|
5.6%
1/18
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18
|
|
Vascular disorders
Behcet's syndrome
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.6%
1/18
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
1/18
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18
|
|
Gastrointestinal disorders
Proctalgia
|
11.1%
2/18
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.6%
1/18
|
|
Hepatobiliary disorders
Liver disorder
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.1%
2/18
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
5.6%
1/18
|
|
General disorders
Malaise
|
5.6%
1/18
|
|
General disorders
Puncture site reaction
|
5.6%
1/18
|
|
General disorders
Pyrexia
|
11.1%
2/18
|
|
Investigations
Antinuclear antibody increased
|
11.1%
2/18
|
|
Investigations
Double stranded DNA antibody positive
|
44.4%
8/18
|
|
Investigations
White blood cell count decreased
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
11.1%
2/18
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Tongue injury
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Wound
|
5.6%
1/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER