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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-650 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-650 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshiaki Ishigatsubo, MD, Ph.D | Yokohama City University Graduate School of Medicine | Study Director |
| Toshifumi Hibi, MD | Kitasato University Kitasato Institute Hospital | Study Director |
| Shunsei Hirohata, MD | Kitasato University School of Medicine | Study Director |
| Kazuoki Kondo, MD | Mitsubihsi Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Chūbu | Japan | ||||
| Investigational site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27310969 | Result | Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, Kondo K, Ishigatsubo Y. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study. Medicine (Baltimore). 2016 Jun;95(24):e3863. doi: 10.1097/MD.0000000000003863. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Acute Neuro-BD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of Complete Responders | Week 30 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TA-650 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA/J 17.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA/J 17.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
Not provided
| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
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|
| Week 14, Week 54 |
| 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. | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
| 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. | Week 14, Week 30, Week 54 |
| 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. | Week 14, Week 30, Week 54 |
| 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. | Week 14, Week 30, Week 54 |
| 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. | Week 14, Week 30, Week 54 |
| 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. | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
| 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. | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
| 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. | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
| 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. | Week 0, Week 14, Week 30, Week 54 |
| 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 | 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. | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
| 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". | Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
| 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". | Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
| Hokkaido |
| Japan |
| Investigational site | Kanto | Japan |
| Investigational site | Kinki | Japan |
| Investigational site | Kyusyu | Japan |
| Investigational site | Tōhoku | Japan |
| Withdrawal by Subject |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. | Posted | Number | percentage of Complete Responders | Week 14, Week 54 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
|
|
|
| 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. | Posted | Number | participants | Week 14, Week 30, Week 54 |
|
|
|
| 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. | Posted | Number | participants | Week 14, Week 30, Week 54 |
|
|
|
| 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. | Posted | Number | participants | Week 14, Week 30, Week 54 |
|
|
|
| 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. | Posted | Number | participants | Week 14, Week 30, Week 54 |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | mg/dL | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | mg/dL | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | mm/hr | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
|
|
|
| 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. | Posted | Number | cells/mL | Week 0, Week 14, Week 30, Week 54 |
|
|
|
| Secondary | Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD | Posted | Number | pg/mL | Week 0, Week 14, Week 30, Week 54 |
|
|
|
| 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. | Posted | Number | participants | Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
|
|
|
| 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". | Posted | Number | participants | Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
|
|
|
| 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". | Posted | Number | participants | Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54 |
|
|
|
| 2 |
| 18 |
| 17 |
| 18 |
| Behcet's syndrome | Vascular disorders | MedDRA/J 17.0 |
|
| Enteritis infectious | Infections and infestations | MedDRA/J 17.0 |
|
| Gastroenteritis | Infections and infestations | MedDRA/J 17.0 |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA/J 17.0 |
|
| Influenza | Infections and infestations | MedDRA/J 17.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J 17.0 |
|
| Periodontitis | Infections and infestations | MedDRA/J 17.0 |
|
| Pharyngitis | Infections and infestations | MedDRA/J 17.0 |
|
| Pulpitis dental | Infections and infestations | MedDRA/J 17.0 |
|
| Tinea pedis | Infections and infestations | MedDRA/J 17.0 |
|
| Tonsillitis | Infections and infestations | MedDRA/J 17.0 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA/J 17.0 |
|
| Depressive symptom | Psychiatric disorders | MedDRA/J 17.0 |
|
| Somatoform disorder | Psychiatric disorders | MedDRA/J 17.0 |
|
| Dizziness | Nervous system disorders | MedDRA/J 17.0 |
|
| Dysaesthesia | Nervous system disorders | MedDRA/J 17.0 |
|
| Headache | Nervous system disorders | MedDRA/J 17.0 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA/J 17.0 |
|
| Intracranial hypotension | Nervous system disorders | MedDRA/J 17.0 |
|
| Somnolence | Nervous system disorders | MedDRA/J 17.0 |
|
| Tension headache | Nervous system disorders | MedDRA/J 17.0 |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA/J 17.0 |
|
| Dry eye | Eye disorders | MedDRA/J 17.0 |
|
| Palpitations | Cardiac disorders | MedDRA/J 17.0 |
|
| Behcet's syndrome | Vascular disorders | MedDRA/J 17.0 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J 17.0 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA/J 17.0 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J 17.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA/J 17.0 |
|
| Gastritis | Gastrointestinal disorders | MedDRA/J 17.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA/J 17.0 |
|
| Proctalgia | Gastrointestinal disorders | MedDRA/J 17.0 |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA/J 17.0 |
|
| Liver disorder | Hepatobiliary disorders | MedDRA/J 17.0 |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA/J 17.0 |
|
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA/J 17.0 |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA/J 17.0 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA/J 17.0 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA/J 17.0 |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA/J 17.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J 17.0 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/J 17.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/J 17.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J 17.0 |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA/J 17.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA/J 17.0 |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA/J 17.0 |
|
| Malaise | General disorders | MedDRA/J 17.0 |
|
| Puncture site reaction | General disorders | MedDRA/J 17.0 |
|
| Pyrexia | General disorders | MedDRA/J 17.0 |
|
| Antinuclear antibody increased | Investigations | MedDRA/J 17.0 |
|
| Double stranded DNA antibody positive | Investigations | MedDRA/J 17.0 |
|
| White blood cell count decreased | Investigations | MedDRA/J 17.0 |
|
| Administration related reaction | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
| Wound | Injury, poisoning and procedural complications | MedDRA/J 17.0 |
|
Not provided
| D014605 |
| Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| Week 54 (n=10, 1, 1, 4) |
|
|
| Week 6 (n=11, 3, 4) |
|
| Week 10 (n=11, 3, 4) |
|
| Week 14 (n=11, 3, 4) |
|
| Week 18 (n=11, 3, 4) |
|
| Week 22 (n=11, 3, 4) |
|
| Week 26 (n=11, 2, 4) |
|
| Week 30 (n=11, 2, 4) |
|
| Week 34 (n=11, 2, 4) |
|
| Week 38 (n=11, 2, 4) |
|
| Week 42 (n=10, 2, 4) |
|
| Week 46 (n=10, 2, 4) |
|
| Week 50 (n=10, 2, 4) |
|
| Week 54 (n=10, 2, 4) |
|
| Final (n=11, 3, 4) |
|
| Title | Measurements |
|---|---|
|
| Reduced to > 1/2 or increase: Week 14 (n=11) |
|
| The ulcer was cured or scarred: Week 30 (n=11) |
|
| Reduced to = < 1/4: Week 30 (n=11) |
|
| Reduced to > 1/4 to = < 1/2: Week 30 (n=11) |
|
| Reduced to > 1/2 or increase: Week 30 (n=11) |
|
| The ulcer was cured or scarred: Week 54 (n=9) |
|
| Reduced to = < 1/4: Week 54 (n=9) |
|
| Reduced to > 1/4 to = < 1/2: Week 54 (n=9) |
|
| Reduced to > 1/2 or increase: Week 54 (n=9) |
|
| The ulcer was cured or scarred: Final (n=11) |
|
| Reduced to = < 1/4: Final (n=11) |
|
| Reduced to > 1/4 to = < 1/2: Final (n=11) |
|
| Reduced to > 1/2 or increase: Final (n=11) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Improved, Week 30 |
|
| Unchanged, Week 30 |
|
| Worsened, Week 30 |
|
| Improved, Week 54 |
|
| Unchanged, Week 54 |
|
| Worsened, Week 54 |
|
| Title | Measurements |
|---|---|
|
| Week 10 (n=11) |
|
| Week 14 (n=10) |
|
| Week 18 (n=11) |
|
| Week 22 (n=11) |
|
| Week 26 (n=11) |
|
| Week 30 (n=11) |
|
| Week 34 (n=11) |
|
| Week 38 (n=11) |
|
| Week 42 (n=10) |
|
| Week 46 (n=10) |
|
| Week 50 (n=10) |
|
| Week 54 (n=10) |
|
| Final (n=11) |
|
| Title | Measurements |
|---|---|
|
| Week 10 |
|
| Week 14 |
|
| Week 18 |
|
| Week 22 |
|
| Week 26 |
|
| Week 30 |
|
| Week 34 |
|
| Week 38 |
|
| Week 42 |
|
| Week 46 |
|
| Week 50 |
|
| Week 54 |
|
| Final |
|
| Title | Measurements |
|---|---|
|
| Week 10 |
|
| Week 14 |
|
| Week 18 |
|
| Week 22 |
|
| Week 26 |
|
| Week 30 |
|
| Week 34 |
|
| Week 38 |
|
| Week 42 |
|
| Week 46 |
|
| Week 50 |
|
| Week 54 |
|
| Final |
|
| Week 30 |
|
| Week 54 |
|
| At discontinuation |
|
| Title | Measurements |
|---|---|
|
| Week 30 |
|
| Week 54 |
|
| At discontinuation |
|
| Title | Measurements |
|---|---|
|
| Week 14 (n=11) |
|
| Week 18 (n=11) |
|
| Week 22 (n=11) |
|
| Week 26 (n=11) |
|
| Week 30 (n=11) |
|
| Week 34 (n=11) |
|
| Week 38 (n=11) |
|
| Week 42 (n=10) |
|
| Week 46 (n=10) |
|
| Week 50 (n=10) |
|
| Week 54 (n=10) |
|
| Final (n=11) |
|
| Title | Measurements |
|---|---|
|
| Unchanged, Week 2 |
|
| Worsened, Week 2 |
|
| No symptom, Week 6 |
|
| Improved, Week 6 |
|
| Unchanged, Week 6 |
|
| Worsened, Week 6 |
|
| No symptom, Week 10 |
|
| Improved, Week 10 |
|
| Unchanged, Week 10 |
|
| Worsened, Week 10 |
|
| No symptom, Week 14 |
|
| Improved, Week 14 |
|
| Unchanged, Week 14 |
|
| Worsened, Week 14 |
|
| No symptom, Week 18 |
|
| Improved, Week 18 |
|
| Unchanged, Week 18 |
|
| Worsened, Week 18 |
|
| No symptom, Week 22 |
|
| Improved, Week 22 |
|
| Unchanged, Week 22 |
|
| Worsened, Week 22 |
|
| No symptom, Week 26 |
|
| Improved, Week 26 |
|
| Unchanged, Week 26 |
|
| Worsened, Week 26 |
|
| No symptom, Week 30 |
|
| Improved, Week 30 |
|
| Unchanged, Week 30 |
|
| Worsened, Week 30 |
|
| No symptom, Week 34 |
|
| Improved, Week 34 |
|
| Unchanged, Week 34 |
|
| Worsened, Week 34 |
|
| No symptom, Week 38 |
|
| Improved, Week 38 |
|
| Unchanged, Week 38 |
|
| Worsened, Week 38 |
|
| No symptom, Week 42 |
|
| Improved, Week 42 |
|
| Unchanged, Week 42 |
|
| Worsened, Week 42 |
|
| No symptom, Week 46 |
|
| Improved, Week 46 |
|
| Unchanged, Week 46 |
|
| Worsened, Week 46 |
|
| No symptom, Week 50 |
|
| Improved, Week 50 |
|
| Unchanged, Week 50 |
|
| Worsened, Week 50 |
|
| No symptom, Week 54 |
|
| Improved, Week 54 |
|
| Unchanged, Week 54 |
|
| Worsened, Week 54 |
|
| No symptom, at discontinuations |
|
| Improved, at discontinuations |
|
| Unchanged, at discontinuations |
|
| Worsened, at discontinuations |
|
| Title | Measurements |
|---|---|
|
| Worsened, Week 2 |
|
| No symptom, Week 6 |
|
| Improved, Week 6 |
|
| Unchanged, Week 6 |
|
| Worsened, Week 6 |
|
| No symptom, Week 10 |
|
| Improved, Week 10 |
|
| Unchanged, Week 10 |
|
| Worsened, Week 10 |
|
| No symptom, Week 14 |
|
| Improved, Week 14 |
|
| Unchanged, Week 14 |
|
| Worsened, Week 14 |
|
| No symptom, Week 18 |
|
| Improved, Week 18 |
|
| Unchanged, Week 18 |
|
| Worsened, Week 18 |
|
| No symptom, Week 22 |
|
| Improved, Week 22 |
|
| Unchanged, Week 22 |
|
| Worsened, Week 22 |
|
| No symptom, Week 26 |
|
| Improved, Week 26 |
|
| Unchanged, Week 26 |
|
| Worsened, Week 26 |
|
| No symptom, Week 30 |
|
| Improved, Week 30 |
|
| Unchanged, Week 30 |
|
| Worsened, Week 30 |
|
| No symptom, Week 34 |
|
| Improved, Week 34 |
|
| Unchanged, Week 34 |
|
| Worsened, Week 34 |
|
| No symptom, Week 38 |
|
| Improved, Week 38 |
|
| Unchanged, Week 38 |
|
| Worsened, Week 38 |
|
| No symptom, Week 42 |
|
| Improved, Week 42 |
|
| Unchanged, Week 42 |
|
| Worsened, Week 42 |
|
| No symptom, Week 46 |
|
| Improved, Week 46 |
|
| Unchanged, Week 46 |
|
| Worsened, Week 46 |
|
| No symptom, Week 50 |
|
| Improved, Week 50 |
|
| Unchanged, Week 50 |
|
| Worsened, Week 50 |
|
| No symptom, Week 54 |
|
| Improved, Week 54 |
|
| Unchanged, Week 54 |
|
| Worsened, Week 54 |
|
| No symptom, Final |
|
| Improved, Final |
|
| Unchanged, Final |
|
| Worsened, Final |
|