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The purpose of this study is to evaluate how anakinra relieves pain for patients with acute gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The patients will be divided in different treatment groups to compare anakinra to the available drug triamcinolone.
Patients will be randomized to treatment at their first gout flare in the study. The first treatment period will be followed by an extension period during which the patients will receive the same treatment for any subsequent flares within 52 weeks of randomization of last patient in the study. The extension period for the individual patient in the study will be maximum two years (104 weeks). Each new flare treated will initiate a new series of study visits and assessments according to specified schedule of events. Only if a patient experience a new flare after Day 15 of the latest flare they can start a new treatment period. The comparison of primary interest is between anakinra (100 mg and 200 mg combined) and 40 mg triamcinolone, and as a secondary objective the 2 different doses of anakinra will be evaluated as well as assessment for subsequent flares.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anakinra 100 mg | Experimental | 1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg |
|
| Anakinra 200 mg | Experimental | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg |
|
| Triamcinolone 40 mg | Active Comparator | 2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra 100 mg | Drug | 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS | Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100). Average of the assessments performed at 24, 48 and 72 hours. | At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale | Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 5-point Likert scale (0-4 point scale: "none", "mild", "moderate", "severe", "extreme") at time points baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8. |
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Inclusion Criteria:
Inclusion criteria for treatment of subsequent flare(s)
Exclusion Criteria:
Exclusion criteria for treatment of subsequent flare(s):
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| Name | Affiliation | Role |
|---|---|---|
| Sven Ohlman, MD, PhD | Swedish Orphan Biovitrum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Fundamental Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33605029 | Derived | Saag KG, Khanna PP, Keenan RT, Ohlman S, Osterling Koskinen L, Sparve E, Akerblad AC, Wiken M, So A, Pillinger MH, Terkeltaub R. A Randomized, Phase II Study Evaluating the Efficacy and Safety of Anakinra in the Treatment of Gout Flares. Arthritis Rheumatol. 2021 Aug;73(8):1533-1542. doi: 10.1002/art.41699. Epub 2021 Jul 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Triamcinolone 40 mg | 2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2018 | Apr 30, 2020 |
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| Triamcinolone Acetonide 40 mg | Drug | 1 mL intramuscular injection of a 40 mg/mL injectable suspension |
|
|
| Placebo to Anakinra 100 mg | Drug | sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe |
|
|
| Placebo to Triamcinolone Acetonide 40 mg | Drug | 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| At baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8 for the first gout flare treated in the study |
| Median Time to Onset of Effect | Onset of effect defined as 20% change from baseline pain intensity in the index joint on a visual analogue scale (VAS) | From baseline (predose) up to Day15 of the first flare treated in the study |
| Median Time to Response | Response defined as 50% change from baseline pain intensity on a visual analogue scale (VAS) | From baseline (predose) up to Day15 of the first flare treated in the study |
| Median Time to Resolution of Pain | Resolution of pain defined as <10 mm on VAS, a continuous 0 to 100 mm visual analogue scale, ranging from no pain (0) to unbearable pain (100), in the index joint | From baseline (predose) up to Day15 of the first flare |
| Median Time to First Intake of Rescue Medication From First Investigational Drug Administration | Time to first intake of rescue medication for acute gout, measured in hours from first investigational drug administration | From Day 1 to Day 15 for the first flare treated |
| Physician's Assessment of Global Response to Treatment | 5-point Likert scale (0- to 4-point scale: "none", "mild", "moderate", "severe, "extreme") where higher score mean worse outcome | At 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 4-point Likert scale (0=no pain, 1= mild/patient states there is pain when touched, 2= moderate/patient states there is pain and Winces, 3=severe/patient states there is pain, winces and withdraws | at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| Physician's Assessment of Clinical Signs in Index Joint: Swelling | 4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins) | at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| Physician's Assessment of Clinical Signs in Index Joint: Erythema | Physicians assessment of clinical signs with 2 outcomes: Absent=no erythema, present=erythema | at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 5-point Likert scale (0- to 4-point scale: 0=excellent, 1=very good, 2=good, 3=fair, 4=poor response to treatment) where lower rate indicates better response to treatment | at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| Change From Baseline in the Inflammatory Biomarker C Reactive Protein | This endpoint represents the change from baseline, mg/dL, of the inflammatory biomarker C reactive protein | baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | This endpoint represents the change from baseline, mg/L, of the inflammatory biomarker Serum amyloid A | baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| The Percent of Patients With at Least One Adverse Event | All adverse events to be recorded Day 1 - Day 28 for each flare. Serious adverse events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence. | Through study completion, at 12 weeks after last flare treated during the extension period |
| The Percent of Patients With at Least One Serious Adverse Event, Including Death | Serious Adverse Events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence. | Through study completion, at 12 weeks after last flare treated during the extension period |
| Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra | Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period |
| Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies | Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated treated during the extension period |
| Proportion of Patients With Neutralizing Antibodies | Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies | Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period |
| Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | SF-36® measures the impact of disease on overall quality of life. It consists of 8 individual domains. Score range from 0 to 100, where 0 represents the worst possible health and 100 is perfect health. | at baseline, Day 8 and Day 15 for the first flare treated in the study |
| Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Exploratory objective. The EQ-5D-5L, a self-report questionnaire, is a descriptive system of Health related quality of life (HRQL) states consisting of 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression), each of which can have 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. | at baseline, Day 8 and Day 15 for the first flare treated in the study |
| Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | The WPAI yeilds four types of scores of which Work productivity loss is one. SHP is derived from WPAI as follows: The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows: Questions: Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities Scores: Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working). Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10. | Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period |
| Health Care Resource Utilization Due to a Gouty Arthritis Flare | Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits | Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period |
| Gulf Shores |
| Alabama |
| 36542 |
| United States |
| Coastal Clinical Research, Inc | Mobile | Alabama | 36608 | United States |
| Advanced Research Center | Anaheim | California | 92805 | United States |
| Delta Waves Sleep Disorder and Research Center | Colorado Springs | Colorado | 80918 | United States |
| Pulmonary Associates of Brandon | Brandon | Florida | 33511 | United States |
| Meridien Research | Brooksville | Florida | 34601 | United States |
| Health Awareness | Jupiter | Florida | 33458 | United States |
| Well Pharma Medical Research | Miami | Florida | 33143 | United States |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States |
| Clinical Research Trials of Florida | Tampa | Florida | 33607 | United States |
| Meridien Research, Inc | Tampa | Florida | 33634 | United States |
| Kaushik Amin MD | Conyers | Georgia | 30013 | United States |
| Alta Pharmaceutical Research Center | Dunwoody | Georgia | 30338 | United States |
| Lemah Creek Clinical Research | Melrose Park | Illinois | 60160 | United States |
| The Research Group of Lexington | Lexington | Kentucky | 40503 | United States |
| Clinical Trials Management | Metairie | Louisiana | 70006 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5422 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Boiling Springs Medical Research, Inc. | Shelby | North Carolina | 28150 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Hightop Medical Research Center | Cincinnati | Ohio | 45224 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Clinical Research Solutions - Franklin | Franklin | Tennessee | 37067 | United States |
| Clinical Research Solutions | Smyrna | Tennessee | 37167 | United States |
| Renaissance Clinical Research and Hypertension Clinic of Texas, PLLC | Dallas | Texas | 75234 | United States |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | United States |
| Accurate Clinical Management | Pasadena | Texas | 77505 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Wade Family Medicine | Bountiful | Utah | 84010 | United States |
| Ericksen Research & Development | Clinton | Utah | 84015 | United States |
| Advanced Clinical Research - West Jordan | West Jordan | Utah | 84088 | United States |
| Commonwealth Clinical Research Specialists, Inc. | Richmond | Virginia | 23235 | United States |
| Corporation Lane Internal Medicine and Research Center | Virginia Beach | Virginia | 23462 | United States |
| Mileground Physicians, PLLC | Morgantown | West Virginia | 26505 | United States |
| Clinical Investigations Specialists, Inc. | Kenosha | Wisconsin | 53142 | United States |
| FG001 | Anakinra 100 mg | 1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
| FG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
| Intention To Treat Populatio |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Triamcinolone 40 mg | 2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe |
| BG001 | Anakinra 100 mg | 1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
| BG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS | Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100). Average of the assessments performed at 24, 48 and 72 hours. | Posted | Mean | 95% Confidence Interval | Units on a scale | At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale | Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 5-point Likert scale (0-4 point scale: "none", "mild", "moderate", "severe", "extreme") at time points baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8. | Posted | Mean | Standard Deviation | Score on a scale | At baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8 for the first gout flare treated in the study |
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| Secondary | Median Time to Onset of Effect | Onset of effect defined as 20% change from baseline pain intensity in the index joint on a visual analogue scale (VAS) | Posted | Median | 95% Confidence Interval | Hours | From baseline (predose) up to Day15 of the first flare treated in the study |
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| Secondary | Median Time to Response | Response defined as 50% change from baseline pain intensity on a visual analogue scale (VAS) | Posted | Median | 95% Confidence Interval | Hours | From baseline (predose) up to Day15 of the first flare treated in the study |
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| Secondary | Median Time to Resolution of Pain | Resolution of pain defined as <10 mm on VAS, a continuous 0 to 100 mm visual analogue scale, ranging from no pain (0) to unbearable pain (100), in the index joint | Posted | Median | 95% Confidence Interval | Hours | From baseline (predose) up to Day15 of the first flare |
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| Secondary | Median Time to First Intake of Rescue Medication From First Investigational Drug Administration | Time to first intake of rescue medication for acute gout, measured in hours from first investigational drug administration | Posted | Median | 95% Confidence Interval | Hours | From Day 1 to Day 15 for the first flare treated |
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| Secondary | Physician's Assessment of Global Response to Treatment | 5-point Likert scale (0- to 4-point scale: "none", "mild", "moderate", "severe, "extreme") where higher score mean worse outcome | Posted | Mean | 95% Confidence Interval | Score on a scale | At 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| |||||||||||||||||||||||||||||||||||
| Secondary | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 4-point Likert scale (0=no pain, 1= mild/patient states there is pain when touched, 2= moderate/patient states there is pain and Winces, 3=severe/patient states there is pain, winces and withdraws | Posted | Count of Participants | Participants | at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins) | Posted | Count of Participants | Participants | at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Physicians assessment of clinical signs with 2 outcomes: Absent=no erythema, present=erythema | Posted | Count of Participants | Participants | at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 5-point Likert scale (0- to 4-point scale: 0=excellent, 1=very good, 2=good, 3=fair, 4=poor response to treatment) where lower rate indicates better response to treatment | Posted | Count of Participants | Participants | at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | This endpoint represents the change from baseline, mg/dL, of the inflammatory biomarker C reactive protein | Some patients did not undertake all assessments. | Posted | Mean | Standard Deviation | mg/dL | baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
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| Secondary | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | This endpoint represents the change from baseline, mg/L, of the inflammatory biomarker Serum amyloid A | Some patients did not undertake all assessments. | Posted | Mean | Standard Deviation | mg/L | baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study |
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| Secondary | The Percent of Patients With at Least One Adverse Event | All adverse events to be recorded Day 1 - Day 28 for each flare. Serious adverse events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence. | Posted | Number | Percent | Through study completion, at 12 weeks after last flare treated during the extension period |
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| Secondary | The Percent of Patients With at Least One Serious Adverse Event, Including Death | Serious Adverse Events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence. | Posted | Number | Percent | Through study completion, at 12 weeks after last flare treated during the extension period |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra | Some patients did not undertake all assessments. | Posted | Mean | Standard Deviation | ng/mL | Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period |
| ||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies | Some patients did not undertake all assessments. | Posted | Number | participants | Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated treated during the extension period |
| |||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Neutralizing Antibodies | Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies | Some patients did not undertake all assessments. | Posted | Number | participants | Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | SF-36® measures the impact of disease on overall quality of life. It consists of 8 individual domains. Score range from 0 to 100, where 0 represents the worst possible health and 100 is perfect health. | Some patients did not undertake all assessments. | Posted | Mean | Standard Deviation | units on a scale | at baseline, Day 8 and Day 15 for the first flare treated in the study |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Exploratory objective. The EQ-5D-5L, a self-report questionnaire, is a descriptive system of Health related quality of life (HRQL) states consisting of 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression), each of which can have 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. | Posted | Count of Participants | Participants | at baseline, Day 8 and Day 15 for the first flare treated in the study |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | The WPAI yeilds four types of scores of which Work productivity loss is one. SHP is derived from WPAI as follows: The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows: Questions: Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities Scores: Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working). Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10. | Some patients did not undertake all assessments. | Posted | Mean | Standard Deviation | percent | Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period |
| ||||||||||||||||||||||||||||||||||
| Secondary | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits | Some patients did not undertake all assessments. | Posted | Mean | Standard Deviation | days | Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period |
|
The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit
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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 | Triamcinolone 40 mg | 2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg Triamcinolone Acetonide 40 mg: 1 mL intramuscular injection of a 40 mg/mL injectable suspension Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe | 0 | 54 | 0 | 54 | 22 | 54 |
| EG001 | Anakinra 100 mg | 1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension | 0 | 55 | 4 | 55 | 19 | 55 |
| EG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension | 0 | 52 | 1 | 52 | 29 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sickel cell anaemia | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Escherichia infection | Infections and infestations | Systematic Assessment |
| ||
| Haemophilus infection | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutrophilia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Stress | Psychiatric disorders | Systematic Assessment |
| ||
| Anger | Psychiatric disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Mood swings | Psychiatric disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Loss of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Nystagmus | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Eyelid oedema | Eye disorders | Systematic Assessment |
| ||
| Vitreous floaters | Eye disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
| ||
| Shock haemorrhagic | Vascular disorders | Systematic Assessment |
| ||
| Aortic arteriosclerosis | Vascular disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyperchlorhydria | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peritoneal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Umbilical hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Synovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Microalbuminuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal cyst | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal impairment | Renal and urinary disorders | Systematic Assessment |
| ||
| Type IIa hyperlipidaemia | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Injection site erythema | General disorders | Systematic Assessment |
| ||
| Injection site hypersensitivity | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Injection site reaction | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Injection site pruritus | General disorders | Systematic Assessment |
| ||
| Injection site swelling | General disorders | Systematic Assessment |
| ||
| Injection site haematoma | General disorders | Systematic Assessment |
| ||
| Injection site induration | General disorders | Systematic Assessment |
| ||
| Gait disturbance | General disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Impaired healing | General disorders | Systematic Assessment |
| ||
| Blood pressure increased | Investigations | Systematic Assessment |
| ||
| Glomerular filtration rate decreased | Investigations | Systematic Assessment |
| ||
| Troponin T increased | Investigations | Systematic Assessment |
| ||
| Albumin urine present | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| High density lipoprotein decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count increased | Investigations | Systematic Assessment |
| ||
| Blood triglycerides increased | Investigations | Systematic Assessment |
| ||
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Acetabulum fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Sternal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound necrosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kineret Clinical Program Leader | Swedish Orphan Biovitrum | +46(8)6972000 | info@sobi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2018 | Apr 30, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
|
| 72 hours |
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| Anakinra 200 mg |
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| Anakinra 200 mg |
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| Anakinra 200 mg |
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| Anakinra 200 mg |
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 |
| Anakinra 200 mg |
2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG001 |
| Anakinra 100 mg |
1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Anakinra 100 mg: sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| OG002 | Anakinra 200 mg | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Anakinra 100 mg: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection Placebo to Triamcinolone Acetonide 40 mg: 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension |
|
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|
| Improvement 2 step |
|
| Improvement 1 step |
|
| No change |
|
| Deterioration 1 steps |
|
| Deterioration 2 steps |
|
| Deterioration 3 steps |
|
| Detorioration 4 steps |
|
| Missing |
|