Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swedish Child Diabetes Foundation | OTHER |
| Ostergotland County Council, Sweden | OTHER |
| Diamyd Medical AB | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of this study is to:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAD-Alum | Drug | Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability | Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse | 1 months |
| Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability | Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse | 2 months |
| Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline | Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability. | Month 1, 2, 3, 6, 9, 15 and 30 |
| Number of Patients With Clinically Significant Laboratory Findings | Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability | Month 1, 2, 3, 6, 9, 15 and 30 |
| GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) | GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 | 6 months |
| GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) | GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 |
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline | Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test | Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose |
| C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline |
Not provided
Inclusion Criteria:
For females of childbearing potential:
For males of childbearing potential:
a. Condom (male)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnny Ludvigsson, MD,PhD,Prof | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsingborg Hospital | Helsingborg | Sweden | ||||
| Linköping University Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GAD-Alum+Vitamin D+Etanercept | All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GAD-Alum+Vitamin D+Etanercept | All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability | Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse | Safety | Posted | Count of Participants | Participants | 1 months |
|
30 months
Adverse Events were recorded in the Case Report Form at each clinic visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GAD-Alum+Vitamin D+Etanercept | All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnny Ludvigsson, MD, PhD, Prof Linkoeping University | Linkoeping University | +46 13 28 68 54 | Johnny.Ludvigsson@liu.se |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2015 | May 8, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vitamin D | Drug |
|
|
| Etanercept | Drug |
|
| 15 months |
| GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) | GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 | 30 months |
| Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment | Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability | Month 1, 2, 3, 6, 9, 15 and 30 |
Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months |
| Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose |
| C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline | Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months | Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose |
| Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L | Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months | 6 months |
| Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L | Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months | 15 months |
| Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L | Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months | 30 months |
| Hemoglobin A1c (HbA1c), Change From Baseline | Hemoglobin A1c (HbA1c), change from baseline to 6 months | Baseline and 6 months |
| Hemoglobin A1c (HbA1c), Change From Baseline | Hemoglobin A1c (HbA1c), change from baseline to 15 months | Baseline and 15 months |
| Hemoglobin A1c (HbA1c), Change From Baseline | Hemoglobin A1c (HbA1c), change from baseline to 30 months | Baseline and 30 months |
| Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline | Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline | Baseline and 6 months |
| Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline | Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline | Baseline and 15 months |
| Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline | Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline | Baseline and 30 months |
| C-peptide: Stimulated, 90 Minute Value, Change From Baseline | C-peptide: Stimulated, 90 minute value, change from baseline to 6 months | Baseline and 6 months |
| C-peptide: Stimulated, 90 Minute Value, Change From Baseline | C-peptide: Stimulated, 90 minute value, change from baseline to 15 months | Baseline and 15 months |
| C-peptide: Stimulated, 90 Minute Value, Change From Baseline | C-peptide: Stimulated, 90 minute value, change from baseline to 30 months | Baseline and 30 months |
| C-peptide Fasting Concentration, Change From Baseline | C-peptide: Fasting concentration, change from baseline to 6 months | Baseline and 6 months |
| C-peptide Fasting Concentration, Change From Baseline | C-peptide: Fasting, concentration, change from baseline to 15 months | Baseline and 15 months |
| C-peptide Fasting Concentration, Change From Baseline | C-peptide: Fasting, concentration, change from baseline to 30 months | Baseline and 30 months |
| Spontaneous IL-17a Secretion | Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months | Baseline, 6 months, 9 months, 15 months and 30 months |
| GAD65-induced IL-4 Secretion | GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months | Baseline, 6 months, 9 months, 15 months, 30 months |
| GAD65-induced IL-13 Secretion | GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months | Baseline, 6 months, 9 months, 15 months, 30 months |
| GAD65-induced IFN-gamma Secretion | GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months | Baseline, 6 months, 9 months, 15 months, 30 months |
| GAD65-induced TNF-alpha Secretion | GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months | Baseline, 6 months, 9 months, 15 months, 30 months |
| GAD65-induced GM-CSF Secretion | GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months | Baseline, 6 months, 9 months, 15 months, 30 months |
| GAD65-induced MIP-1b Secretion | GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months | Baseline, 6 months, 9 months, 15 months, 30 months |
| GAD65-induced MCP-1 Secretion | GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months | Baseline, 6 months, 9 months, 15 months, 30 months |
| Linköping |
| Sweden |
| Lund University Hospital | Lund | Sweden |
| Skåne University Hospital, UMAS | Malmö | Sweden |
| Örebro University Hospital | Örebro | Sweden |
| Sachsska, Södersjukhuset | Stockholm | Sweden |
| Uddevalla Hospital | Uddevalla | Sweden |
| Västerås Hospital | Västerås | Sweden |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type 1 Diabetes duration | Mean | Standard Deviation | days |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability | Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse | Safety | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Primary | Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline | Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability. | Safety | Posted | Count of Participants | Participants | Month 1, 2, 3, 6, 9, 15 and 30 |
|
|
|
| Primary | Number of Patients With Clinically Significant Laboratory Findings | Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability | Safety | Posted | Count of Participants | Participants | Month 1, 2, 3, 6, 9, 15 and 30 |
|
|
|
| Primary | GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) | GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 | Intention To Treat (ITT) | Posted | Mean | Standard Deviation | U/mL | 6 months |
|
|
|
| Primary | GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) | GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 | ITT | Posted | Mean | Standard Deviation | U/mL | 15 months |
|
|
|
| Primary | GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) | GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 | ITT | Posted | Mean | Standard Deviation | U/mL | 30 months |
|
|
|
| Primary | Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment | Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability | Safety | Posted | Count of Participants | Participants | Month 1, 2, 3, 6, 9, 15 and 30 |
|
|
|
| Secondary | C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline | Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test | ITT, MMTT not performed for 2 patients hence no data available for 2 out of the 20 patients | Posted | Mean | Standard Deviation | nmol/L*min | Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose |
|
|
|
| Secondary | C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline | Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months | ITT | Posted | Mean | Standard Deviation | nmol/L*min | Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose |
|
|
|
| Secondary | C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline | Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months | ITT, , MMTT not performed for 1 patient hence no data available for 1 out of the 20 patients | Posted | Mean | Standard Deviation | nmol/L*min | Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose |
|
|
|
| Secondary | Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L | Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months | ITT | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L | Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months | ITT | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Secondary | Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L | Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months | ITT | Posted | Count of Participants | Participants | 30 months |
|
|
|
| Secondary | Hemoglobin A1c (HbA1c), Change From Baseline | Hemoglobin A1c (HbA1c), change from baseline to 6 months | ITT | Posted | Mean | Standard Deviation | mmol/mol | Baseline and 6 months |
|
|
|
| Secondary | Hemoglobin A1c (HbA1c), Change From Baseline | Hemoglobin A1c (HbA1c), change from baseline to 15 months | ITT | Posted | Mean | Standard Deviation | mmol/mol | Baseline and 15 months |
|
|
|
| Secondary | Hemoglobin A1c (HbA1c), Change From Baseline | Hemoglobin A1c (HbA1c), change from baseline to 30 months | ITT | Posted | Mean | Standard Deviation | mmol/mol | Baseline and 30 months |
|
|
|
| Secondary | Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline | Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline | ITT | Posted | Mean | Standard Deviation | IU | Baseline and 6 months |
|
|
|
| Secondary | Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline | Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline | ITT | Posted | Mean | Standard Deviation | IU | Baseline and 15 months |
|
|
|
| Secondary | Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline | Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline | ITT | Posted | Mean | Standard Deviation | IU | Baseline and 30 months |
|
|
|
| Secondary | C-peptide: Stimulated, 90 Minute Value, Change From Baseline | C-peptide: Stimulated, 90 minute value, change from baseline to 6 months | ITT, not performed for 2 patients hence no data available for 2 out of the 20 patients | Posted | Mean | Standard Deviation | nmol/L | Baseline and 6 months |
|
|
|
| Secondary | C-peptide: Stimulated, 90 Minute Value, Change From Baseline | C-peptide: Stimulated, 90 minute value, change from baseline to 15 months | ITT | Posted | Mean | Standard Deviation | nmol/L | Baseline and 15 months |
|
|
|
| Secondary | C-peptide: Stimulated, 90 Minute Value, Change From Baseline | C-peptide: Stimulated, 90 minute value, change from baseline to 30 months | ITT, not performed for 1 patient hence no data available for 1 out of the 20 patients | Posted | Mean | Standard Deviation | nmol/L | Baseline and 30 months |
|
|
|
| Secondary | C-peptide Fasting Concentration, Change From Baseline | C-peptide: Fasting concentration, change from baseline to 6 months | ITT | Posted | Mean | Standard Deviation | nmol/L | Baseline and 6 months |
|
|
|
| Secondary | C-peptide Fasting Concentration, Change From Baseline | C-peptide: Fasting, concentration, change from baseline to 15 months | ITT | Posted | Mean | Standard Deviation | nmol/L | Baseline and 15 months |
|
|
|
| Secondary | C-peptide Fasting Concentration, Change From Baseline | C-peptide: Fasting, concentration, change from baseline to 30 months | ITT | Posted | Mean | Standard Deviation | nmol/L | Baseline and 30 months |
|
|
|
| Secondary | Spontaneous IL-17a Secretion | Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months | ITT | Posted | Median | Standard Deviation | pg/ml | Baseline, 6 months, 9 months, 15 months and 30 months |
|
|
|
| Secondary | GAD65-induced IL-4 Secretion | GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months | ITT | Posted | Median | Standard Deviation | pg/ml | Baseline, 6 months, 9 months, 15 months, 30 months |
|
|
|
| Secondary | GAD65-induced IL-13 Secretion | GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months | ITT | Posted | Median | Standard Deviation | pg/ml | Baseline, 6 months, 9 months, 15 months, 30 months |
|
|
|
| Secondary | GAD65-induced IFN-gamma Secretion | GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months | ITT | Posted | Median | Standard Deviation | pg/ml | Baseline, 6 months, 9 months, 15 months, 30 months |
|
|
|
| Secondary | GAD65-induced TNF-alpha Secretion | GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months | ITT | Posted | Median | Standard Deviation | pg/ml | Baseline, 6 months, 9 months, 15 months, 30 months |
|
|
|
| Secondary | GAD65-induced GM-CSF Secretion | GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months | ITT | Posted | Median | Standard Deviation | pg/ml | Baseline, 6 months, 9 months, 15 months, 30 months |
|
|
|
| Secondary | GAD65-induced MIP-1b Secretion | GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months | ITT | Posted | Median | Standard Deviation | pg/ml | Baseline, 6 months, 9 months, 15 months, 30 months |
|
|
|
| Secondary | GAD65-induced MCP-1 Secretion | GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months | ITT | Posted | Median | Standard Deviation | pg/ml | Baseline, 6 months, 9 months, 15 months, 30 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
|
| IL-17a, 9 months |
|
|
| IL-17a,15 months |
|
|
| IL-17a, 30 months |
|
|
|
| IL-4, 9 months |
|
|
| IL-4, 15 months |
|
|
| IL-4, 30 months |
|
|
|
| IL-13, 9 months |
|
|
| IL-13, 15 months |
|
|
| IL-13, 30 months |
|
|
|
| IFN-gamma, 9 months |
|
|
| IFN-gamma, 15 months |
|
|
| IFN-gamma, 30 months |
|
|
|
| TNF-alpha, 9 months |
|
|
| TNF-alpha, 15 months |
|
|
| TNF-alpha, 30 months |
|
|
|
| GM-CSF, 9 months |
|
|
| GM-CSF, 15 months |
|
|
| GM-CSF, 30 months |
|
|
|
| MIP-1b, 9 months |
|
|
| MIP-1b, 15 months |
|
|
| MIP-1b, 30 months |
|
|
|
| MCP-1, 9 months |
|
|
| MCP-1, 15 months |
|
|
| MCP-1, 30 months |
|
|