Behcet's Disease, Behcet Syndrome, Neuro-Behcet's Disease
Conditions
Keywords
Behcet's disease, intestinal Behcet's disease, neuro-Behcet's disease, vascular Behcet's disease
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650 in patients with Behcet's disease ( BD ) with special lesions after the administration of TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to week 46.
Interventions
DRUGTA-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.
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who were diagnosed with the complete or incomplete type of Behcet's disease according to The criteria for a diagnosis of Behcet's disease, Ministry of Health, Labour and Welfare in Japan (partially revised in 2010) * Patients who have special lesions despite having received conventional treatments for special lesions, or patients who cannot receive conventional treatments due to intolerability. * Patients who have clinical symptoms associated with each special lesions.
Exclusion criteria
* Patients with intestinal, neuro-, vascular Behcet's disease in whom a differential diagnosis of each Behcet's disease from other conditions． * Patients who have received treatment with infliximab within 1 year before enrollment for another purpose than treating special lesions; or patients whose previous treatment with infliximab was discontinued due to adverse events. * Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving acquirement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Response at Week 30 | Week 30 | We defined the patient who met the following criteria as the complete responders. The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, Computed tomography (CT) or Positron emission tomography/Computed tomography (PET/CT) findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 | The VAS evaluation measured using the General VAS evaluation From and the range is from 0 to 100 mm. The best condition per one week before evaluation visit for the clinical symptoms associated with each BD is defined as 0 and the worst condition is defined as 100. The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study. |
| Imaging Findings:Endoscopic Examination for Intestinal BD | Week 14, Week 30, Week 54 | The investigator assessed the length of the major axis of the principal intestinal ulcer at day of evaluation and scored in accordance with the following categories, Healed/scarred, Reduced to =\< 25%, Reduced to \> 25% to =\< 50% or Reduced to \> 50%/no change/increased in the principal intestinal ulcer compared to size at Week 0. |
| Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD | Week 14, Week 30, Week 54 | Changes in brain MRI findings were scored at day of evaluation, in accordance with the following categories, No high-intensity areas, Reduction or No changes/increase in the size of high-intensity areas compared to Week 0. |
| Imaging Findings: Brainstem MRI for Chronic Neuro-BD | Week 14, Week 30, Week 54 | Changes in brainstem MRI findings were scored at day of evaluation, in accordance with the following categories, Unchanged or Reduced in the brainstem area compared to Week 0. |
| Imaging Findings: CT, PET/CT for Vascular-BD | Week 14, Week 30, Week 54 | Changes in CT or PET/CT findings were scored at day of evaluation, in accordance with the following categories, Improves, Unchanged or Worsened by comparison with those at Week 0. |
| Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 | The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study. |
| Percentage of Participants With Complete Response at Week 14 and 54 | Week 14, Week 54 | We defined the patient who met the following criteria as the complete responders. The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, CT or PET/CT findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0. |
| Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 | The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study. |
| Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 0, Week 14, Week 30, Week 54 | The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study. |
| Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 0, Week 14, Week 30, Week 54 | — |
| The Number of Improved Intestinal BD Patients From Baseline | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 | The investigator assessed clinical symptoms associated with intestinal BD in one week before the day of evaluation as No symptom, Very slightly poor, Slightly poor, Poor or Extremely poor. We calculated improved patients in comparison with those for Week 0. |
| Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54 | The investigator assessed the clinical symptoms associated with neuro-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened. |
| Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54 | The investigator assessed the clinical symptoms associated with vascular-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened. |
| Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 | The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 2 |
| 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. | 1 |
| 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. | 4 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Intestinal BD | Acute Neuro-BD | Chronic Progressive Neuro-BD | Vascular BD | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35.0 years STANDARD_DEVIATION 13.4 | 34.0 years STANDARD_DEVIATION 5.7 | 47.0 years | 44.0 years STANDARD_DEVIATION 2.9 | 37.6 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 0 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 1 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 18 |
| serious Total, serious adverse events | 2 / 18 |
Outcome results
Primary
Percentage of Participants With Complete Response at Week 30
We defined the patient who met the following criteria as the complete responders. The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, Computed tomography (CT) or Positron emission tomography/Computed tomography (PET/CT) findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0.
Time frame: Week 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intestinal BD | Percentage of Participants With Complete Response at Week 30 | 54.5 percentage of Complete Responders |
| Acute Neuro-BD | Percentage of Participants With Complete Response at Week 30 | 0 percentage of Complete Responders |
| Chronic Progressive Neuro-BD | Percentage of Participants With Complete Response at Week 30 | 100 percentage of Complete Responders |
| Vascular BD | Percentage of Participants With Complete Response at Week 30 | 100 percentage of Complete Responders |
Secondary
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.
Time frame: Week 0, Week 14, Week 30, Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 14 | 4 cells/mL |
| Intestinal BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 54 | NA cells/mL |
| Intestinal BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 30 | 1 cells/mL |
| Intestinal BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | At discontinuation | NA cells/mL |
| Intestinal BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 0 | 37 cells/mL |
| Acute Neuro-BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | At discontinuation | 2 cells/mL |
| Acute Neuro-BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 0 | 3 cells/mL |
| Acute Neuro-BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 14 | 2 cells/mL |
| Acute Neuro-BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 30 | NA cells/mL |
| Acute Neuro-BD | Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD | Week 54 | NA cells/mL |
Secondary
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
The investigator assessed the clinical symptoms associated with neuro-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened.
Time frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 22 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 6 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 42 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 22 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, at discontinuations | NA participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 42 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 54 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 38 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 22 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 10 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 38 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 26 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 2 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 38 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 26 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 54 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 38 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 26 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 10 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 34 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 26 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 22 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 34 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 30 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 50 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 34 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 30 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 10 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 34 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 30 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, at discontinuations | NA participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 30 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 50 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 10 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 6 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 50 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 14 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, at discontinuations | NA participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 50 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 14 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, at discontinuations | NA participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 46 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 14 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 6 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 46 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 14 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 2 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 2 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 18 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 54 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 46 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 18 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 6 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 46 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 18 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 2 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 42 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 18 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 54 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 42 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 46 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 2 | 1 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 2 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 2 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 2 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 6 | 1 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 6 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 6 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 6 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 10 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 10 | 1 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 10 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 10 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 14 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 14 | 1 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 14 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 14 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 18 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 18 | 1 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 18 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 18 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 22 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 22 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 22 | 1 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 22 | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 26 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 26 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 26 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 26 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 30 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 30 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 30 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 30 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 34 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 34 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 34 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 34 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 38 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 38 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 38 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 38 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 42 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 42 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 42 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 42 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 46 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 46 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 46 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 50 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 50 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 50 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 50 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 54 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 54 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 54 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 54 | NA participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, at discontinuations | 1 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, at discontinuations | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, at discontinuations | 0 participants |
| Acute Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, at discontinuations | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 6 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 42 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 22 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, at discontinuations | NA participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 42 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 18 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 54 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 42 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 18 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 6 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 42 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 18 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, at discontinuations | NA participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 46 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 18 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 14 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 46 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 14 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 54 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 46 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 14 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 6 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 46 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 14 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 2 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 50 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 10 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, at discontinuations | NA participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 50 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 10 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 2 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 50 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 30 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 10 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 30 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 30 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 2 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 34 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 30 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 50 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 34 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 26 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 10 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 34 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 26 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, at discontinuations | NA participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 34 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 26 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 54 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 38 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | No symptom, Week 26 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 6 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 38 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 22 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 2 | 1 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 38 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Unchanged, Week 22 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 54 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Worsened, Week 38 | 0 participants |
| Chronic Progressive Neuro-BD | Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients | Improved, Week 22 | 0 participants |
Secondary
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
The investigator assessed the clinical symptoms associated with vascular-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened.
Time frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 2 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 2 | 2 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 2 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 2 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 6 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 6 | 2 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 6 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 6 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 10 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 10 | 2 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 10 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 10 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 14 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 14 | 2 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 14 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 14 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 18 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 18 | 4 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 18 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 18 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 22 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 22 | 3 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 22 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 22 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 26 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 26 | 3 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 26 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 26 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 30 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 30 | 4 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 30 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 30 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 34 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 34 | 3 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 34 | 1 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 34 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 38 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 38 | 4 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 38 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 38 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 42 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 42 | 4 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 42 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 42 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 46 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 46 | 4 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 46 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 46 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 50 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 50 | 4 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 50 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 50 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Week 54 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Week 54 | 4 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Week 54 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Week 54 | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | No symptom, Final | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Improved, Final | 4 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Unchanged, Final | 0 participants |
| Intestinal BD | Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients | Worsened, Final | 0 participants |
Secondary
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 0 (n=11) | 0.20 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 2 (n=11) | 0.00 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 6 (n=11) | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 10 (n=11) | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 14 (n=10) | 0.15 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 18 (n=11) | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 22 (n=11) | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 26 (n=11) | 0.00 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 30 (n=11) | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 34 (n=11) | 0.00 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 38 (n=11) | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 42 (n=10) | 0.00 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 46 (n=10) | 0.00 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 50 (n=10) | 0.05 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Week 54 (n=10) | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD | Final (n=11) | 0.10 mg/dL |
Secondary
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 0 | 0.90 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 2 | 0.25 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 6 | 0.20 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 10 | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 14 | 0.15 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 18 | 0.15 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 22 | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 26 | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 30 | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 34 | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 38 | 0.15 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 42 | 0.10 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 46 | 0.15 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 50 | 0.05 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Week 54 | 0.15 mg/dL |
| Intestinal BD | Concentration of Inflammatory Biomarker (CRP) of Vascular BD | Final | 0.15 mg/dL |
Secondary
Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
Changes in brain MRI findings were scored at day of evaluation, in accordance with the following categories, No high-intensity areas, Reduction or No changes/increase in the size of high-intensity areas compared to Week 0.
Time frame: Week 14, Week 30, Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD | Reduced high intensity areas, Week 14 (n=2) | 2 participants |
| Intestinal BD | Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD | Reduced high intensity areas, Week 30 (n=1) | 1 participants |
| Intestinal BD | Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD | Reduced high intensity areas, Week 54 (n=1) | 1 participants |
Secondary
Imaging Findings: Brainstem MRI for Chronic Neuro-BD
Changes in brainstem MRI findings were scored at day of evaluation, in accordance with the following categories, Unchanged or Reduced in the brainstem area compared to Week 0.
Time frame: Week 14, Week 30, Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Imaging Findings: Brainstem MRI for Chronic Neuro-BD | Unchanged brain stem area, Week 14 | 1 participants |
| Intestinal BD | Imaging Findings: Brainstem MRI for Chronic Neuro-BD | Unchanged brain stem area, Week 30 | 1 participants |
| Intestinal BD | Imaging Findings: Brainstem MRI for Chronic Neuro-BD | Unchanged brain stem area, Week 54 | 1 participants |
Secondary
Imaging Findings: CT, PET/CT for Vascular-BD
Changes in CT or PET/CT findings were scored at day of evaluation, in accordance with the following categories, Improves, Unchanged or Worsened by comparison with those at Week 0.
Time frame: Week 14, Week 30, Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Improved, Week 14 | 3 participants |
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Unchanged, Week 14 | 1 participants |
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Woesened, Week 14 | 0 participants |
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Improved, Week 30 | 3 participants |
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Unchanged, Week 30 | 1 participants |
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Worsened, Week 30 | 0 participants |
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Improved, Week 54 | 3 participants |
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Unchanged, Week 54 | 1 participants |
| Intestinal BD | Imaging Findings: CT, PET/CT for Vascular-BD | Worsened, Week 54 | 0 participants |
Secondary
Imaging Findings:Endoscopic Examination for Intestinal BD
The investigator assessed the length of the major axis of the principal intestinal ulcer at day of evaluation and scored in accordance with the following categories, Healed/scarred, Reduced to =\< 25%, Reduced to \> 25% to =\< 50% or Reduced to \> 50%/no change/increased in the principal intestinal ulcer compared to size at Week 0.
Time frame: Week 14, Week 30, Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | The ulcer was cured or scarred: Week 14 (n=11) | 9 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to = < 1/4: Week 14 (n=11) | 0 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to > 1/4 to = < 1/2: Week 14 (n=11) | 0 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to > 1/2 or increase: Week 14 (n=11) | 2 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | The ulcer was cured or scarred: Week 30 (n=11) | 9 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to = < 1/4: Week 30 (n=11) | 0 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to > 1/4 to = < 1/2: Week 30 (n=11) | 0 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to > 1/2 or increase: Week 30 (n=11) | 2 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | The ulcer was cured or scarred: Week 54 (n=9) | 8 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to = < 1/4: Week 54 (n=9) | 0 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to > 1/4 to = < 1/2: Week 54 (n=9) | 0 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to > 1/2 or increase: Week 54 (n=9) | 1 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | The ulcer was cured or scarred: Final (n=11) | 9 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to = < 1/4: Final (n=11) | 0 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to > 1/4 to = < 1/2: Final (n=11) | 0 participants |
| Intestinal BD | Imaging Findings:Endoscopic Examination for Intestinal BD | Reduced to > 1/2 or increase: Final (n=11) | 2 participants |
Secondary
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Time frame: Week 0, Week 14, Week 30, Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | At discontinuation | NA pg/mL |
| Intestinal BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 0 | 145 pg/mL |
| Intestinal BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 14 | 2.2 pg/mL |
| Intestinal BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 54 | 1.5 pg/mL |
| Intestinal BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 30 | 1.4 pg/mL |
| Acute Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 30 | NA pg/mL |
| Acute Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | At discontinuation | 6.5 pg/mL |
| Acute Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 54 | NA pg/mL |
| Acute Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 14 | 23 pg/mL |
| Acute Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 0 | 2.5 pg/mL |
| Chronic Progressive Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 14 | 35.1 pg/mL |
| Chronic Progressive Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 54 | 32.1 pg/mL |
| Chronic Progressive Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 0 | 64.5 pg/mL |
| Chronic Progressive Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Week 30 | 5.4 pg/mL |
| Chronic Progressive Neuro-BD | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | At discontinuation | NA pg/mL |
Secondary
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 0 | 31.0 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 2 | 11.0 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 6 | 8.0 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 10 | 7.0 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 14 | 8.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 18 | 6.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 22 | 5.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 26 | 7.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 30 | 4.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 34 | 6.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 38 | 9.0 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 42 | 9.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 46 | 8.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 50 | 8.0 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Week 54 | 6.5 mm/hr |
| Intestinal BD | Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD | Final | 6.5 mm/hr |
Secondary
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
The VAS evaluation measured using the General VAS evaluation From and the range is from 0 to 100 mm. The best condition per one week before evaluation visit for the clinical symptoms associated with each BD is defined as 0 and the worst condition is defined as 100. The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Intestinal BD | 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 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 18 (n=11, 3, 4) | 31.7 units on a scale | Standard Deviation 22.4 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 22 (n=11, 3, 4) | 35.3 units on a scale | Standard Deviation 31.5 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 26 (n=11, 2, 4) | 18.5 units on a scale | Standard Deviation 23.3 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 50 (n=10, 2, 4) | 11.5 units on a scale | Standard Deviation 16.3 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 30 (n=11, 2, 4) | 15.0 units on a scale | Standard Deviation 21.2 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 34 (n=11, 2, 4) | 12.5 units on a scale | Standard Deviation 17.7 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Final (n=11, 3, 4) | 7.7 units on a scale | Standard Deviation 8.6 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 38 (n=11, 2, 4) | 11.5 units on a scale | Standard Deviation 16.3 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 0 (n=11, 3, 4) | 41.3 units on a scale | Standard Deviation 11 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 54 (n=10, 2, 4) | 8.5 units on a scale | Standard Deviation 12 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 2 (n=11, 3, 4) | 33.0 units on a scale | Standard Deviation 23.1 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 42 (n=10, 2, 4) | 13.0 units on a scale | Standard Deviation 18.4 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 6 (n=11, 3, 4) | 15.0 units on a scale | Standard Deviation 17.1 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 10 (n=11, 3, 4) | 23.0 units on a scale | Standard Deviation 20.4 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 14 (n=11, 3, 4) | 28.3 units on a scale | Standard Deviation 30 |
| Acute Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 46 (n=10, 2, 4) | 11.5 units on a scale | Standard Deviation 16.3 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 38 (n=11, 2, 4) | 10.3 units on a scale | Standard Deviation 8.3 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 18 (n=11, 3, 4) | 15.3 units on a scale | Standard Deviation 8.9 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 46 (n=10, 2, 4) | 10.5 units on a scale | Standard Deviation 6.6 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 6 (n=11, 3, 4) | 14.3 units on a scale | Standard Deviation 8.1 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 22 (n=11, 3, 4) | 17.8 units on a scale | Standard Deviation 6.4 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Final (n=11, 3, 4) | 11.3 units on a scale | Standard Deviation 7.9 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 0 (n=11, 3, 4) | 40.5 units on a scale | Standard Deviation 34.4 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 26 (n=11, 2, 4) | 17.5 units on a scale | Standard Deviation 9.8 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 42 (n=10, 2, 4) | 13.5 units on a scale | Standard Deviation 9.3 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 14 (n=11, 3, 4) | 13.5 units on a scale | Standard Deviation 9.8 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 30 (n=11, 2, 4) | 11.8 units on a scale | Standard Deviation 7.5 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 50 (n=10, 2, 4) | 22.8 units on a scale | Standard Deviation 25.4 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 2 (n=11, 3, 4) | 11.8 units on a scale | Standard Deviation 7.8 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 34 (n=11, 2, 4) | 18.8 units on a scale | Standard Deviation 9.2 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 10 (n=11, 3, 4) | 17.8 units on a scale | Standard Deviation 14 |
| Chronic Progressive Neuro-BD | Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD | Week 54 (n=10, 2, 4) | 11.3 units on a scale | Standard Deviation 7.9 |
Secondary
Percentage of Participants With Complete Response at Week 14 and 54
We defined the patient who met the following criteria as the complete responders. The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, CT or PET/CT findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0.
Time frame: Week 14, Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | Percentage of Participants With Complete Response at Week 14 and 54 | Week 14 (n=11, 2, 1, 4) | 54.5 percentage of Complete Responders |
| Intestinal BD | Percentage of Participants With Complete Response at Week 14 and 54 | Week 54 (n=10, 1, 1, 4) | 60 percentage of Complete Responders |
| Acute Neuro-BD | Percentage of Participants With Complete Response at Week 14 and 54 | Week 54 (n=10, 1, 1, 4) | 0 percentage of Complete Responders |
| Acute Neuro-BD | Percentage of Participants With Complete Response at Week 14 and 54 | Week 14 (n=11, 2, 1, 4) | 0 percentage of Complete Responders |
| Chronic Progressive Neuro-BD | Percentage of Participants With Complete Response at Week 14 and 54 | Week 14 (n=11, 2, 1, 4) | 100 percentage of Complete Responders |
| Chronic Progressive Neuro-BD | Percentage of Participants With Complete Response at Week 14 and 54 | Week 54 (n=10, 1, 1, 4) | 100 percentage of Complete Responders |
| Vascular BD | Percentage of Participants With Complete Response at Week 14 and 54 | Week 14 (n=11, 2, 1, 4) | 100 percentage of Complete Responders |
| Vascular BD | Percentage of Participants With Complete Response at Week 14 and 54 | Week 54 (n=10, 1, 1, 4) | 100 percentage of Complete Responders |
Secondary
The Number of Improved Intestinal BD Patients From Baseline
The investigator assessed clinical symptoms associated with intestinal BD in one week before the day of evaluation as No symptom, Very slightly poor, Slightly poor, Poor or Extremely poor. We calculated improved patients in comparison with those for Week 0.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 2 (n=11) | 7 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 6 (n=11) | 9 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 10 (n=11) | 9 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 14 (n=11) | 8 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 18 (n=11) | 11 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 22 (n=11) | 10 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 26 (n=11) | 10 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 30 (n=11) | 10 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 34 (n=11) | 10 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 38 (n=11) | 9 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 42 (n=10) | 8 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 46 (n=10) | 8 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 50 (n=10) | 8 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Week 54 (n=10) | 8 participants |
| Intestinal BD | The Number of Improved Intestinal BD Patients From Baseline | Final (n=11) | 9 participants |