Acute Gouty Arthritis
Conditions
Keywords
Gout, Interleukin 1 receptor antagonist, IL-1 receptor antagonist
Brief summary
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.
Detailed description
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.
Interventions
DRUGAnakinra 100 mg
100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
1 mL intramuscular injection of a 40 mg/mL injectable suspension
DRUGPlacebo to Anakinra 100 mg
sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
DRUGPlacebo to Triamcinolone Acetonide 40 mg
1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
Sponsors
Swedish Orphan Biovitrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed consent * Patient meeting the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2015 gout classification criteria * History of ≥1 self-reported flares of gouty arthritis within 12 months * Current ongoing flare of gouty arthritis characterized by pain intensity * Currently tender and swollen joint * Onset of current flare within 4 days * Intolerant, unresponsive, contraindicated or not appropriate for treatment with NSAIDs and colchicine (both treatment options) * If on urate-lowering therapy, on a stable dose and regimen * Women of childbearing potential willing to use adequate contraception Inclusion criteria for treatment of subsequent flare(s) * Current flare of gouty arthritis characterized by pain intensity * Currently tender and swollen joint * Women of childbearing potential willing to use adequate contraception
Exclusion criteria
* Use of specified pain relief medications or biologics (including glucocorticoids, narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor inhibitors) within specified periods prior to randomization * Contraindication to triamcinolone * Polyarticular gouty arthritis involving more than 4 joints * Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis * History of malignancy within the past 5 years. Exceptions are basal cell skin cancer, carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy. * Known hypersensitivity to Escherichia coli-derived proteins, Kineret® (anakinra), Kenalog® (triamcinolone acetonide) or any components of the products. * Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B or C infection * Presence of severe renal function impairment chronic kidney disease (CKD) stages 4 and 5 * Presence of neutropenia * Uncontrolled clinically significant hematologic, pulmonary, endocrine, metabolic, gastrointestinal, central nervous system or hepatic disease * History of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting, New York Heart Association (NYHA) class III or IV heart failure within the previous 3 months * Patients who have undergone major surgery within 2 weeks, or have an unhealed operation wound/s * Presence of any medical or psychological condition or laboratory result that in the opinion of the investigator might create risk to the patients or to the study. * Earlier or current treatment with anakinra * Pregnant or lactating women * History of \>12 flares overall in the 6 months prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Onset of Effect | From baseline (predose) up to Day15 of the first flare treated in the study | Onset of effect defined as 20% change from baseline pain intensity in the index joint on a visual analogue scale (VAS) |
| Median Time to Response | From baseline (predose) up to Day15 of the first flare treated in the study | Response defined as 50% change from baseline pain intensity on a visual analogue scale (VAS) |
| Median Time to Resolution of Pain | From baseline (predose) up to Day15 of the first flare | 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 |
| Median Time to First Intake of Rescue Medication From First Investigational Drug Administration | From Day 1 to Day 15 for the first flare treated | Time to first intake of rescue medication for acute gout, measured in hours from first investigational drug administration |
| Physician's Assessment of Global Response to Treatment | At 72 hours, Day 8 and Day 15 for the first flare treated in the study | 5-point Likert scale (0- to 4-point scale: none, mild, moderate, severe, extreme) where higher score mean worse outcome |
| Physician's Assessment of Clinical Signs in Index Joint: Tenderness | at 72 hours, Day 8 and Day 15 for the first flare treated in the study | 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 |
| Physician's Assessment of Clinical Signs in Index Joint: Swelling | at 72 hours, Day 8 and Day 15 for the first flare treated in the study | 4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins) |
| Physician's Assessment of Clinical Signs in Index Joint: Erythema | at 72 hours, Day 8 and Day 15 for the first flare treated in the study | Physicians assessment of clinical signs with 2 outcomes: Absent=no erythema, present=erythema |
| Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | at 72 hours, Day 8 and Day 15 for the first flare treated in the study | 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 |
| Change From Baseline in 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 | This endpoint represents the change from baseline, mg/dL, of the inflammatory biomarker C reactive protein |
| 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 | 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 | 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. |
| The Percent of Patients With at Least One Adverse Event | Through study completion, at 12 weeks after last flare treated during the extension period | 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. |
| The Percent of Patients With at Least One Serious Adverse Event, Including Death | Through study completion, at 12 weeks after last flare treated during the extension period | 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. |
| Serum Concentration 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 | This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra |
| Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | 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 | Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies |
| Proportion of Patients With 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 | Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies |
| Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | at baseline, Day 8 and Day 15 for the first flare treated in the study | 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. |
| Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | at baseline, Day 8 and Day 15 for the first flare treated in the study | 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. |
| Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period | 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. |
| Health Care Resource Utilization Due to a Gouty Arthritis Flare | Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period | Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits |
| Change From Baseline in 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 | This endpoint represents the change from baseline, mg/L, of the inflammatory biomarker Serum amyloid A |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 55 |
| 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 | 56 |
| 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 | 54 |
| Total | 165 |
Baseline characteristics
| Characteristic | Anakinra 100 mg | Anakinra 200 mg | Triamcinolone 40 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 11.9 | 54.0 years STANDARD_DEVIATION 13.1 | 56.8 years STANDARD_DEVIATION 10.3 | 54.8 years STANDARD_DEVIATION 11.8 |
| Race/Ethnicity, Customized Race Asian | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 15 Participants | 12 Participants | 15 Participants | 42 Participants |
| Race/Ethnicity, Customized Race White | 38 Participants | 42 Participants | 39 Participants | 119 Participants |
| Region of Enrollment United States | 56 participants | 54 participants | 55 participants | 165 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 48 Participants | 47 Participants | 48 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 55 | 0 / 52 |
| other Total, other adverse events | 22 / 54 | 19 / 55 | 29 / 52 |
| serious Total, serious adverse events | 0 / 54 | 4 / 55 | 1 / 52 |
Outcome results
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.
Time frame: At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Triamcinolone 40 mg | 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 | 72 hours | -45.2 Units on a scale |
| Triamcinolone 40 mg | 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 | 48 hours | -43.4 Units on a scale |
| Triamcinolone 40 mg | 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 | 24 hours | -26.1 Units on a scale |
| Anakinra 100 mg | 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 | 72 hours | -51.6 Units on a scale |
| Anakinra 100 mg | 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 | 24 hours | -32.5 Units on a scale |
| Anakinra 100 mg | 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 | 48 hours | -42.9 Units on a scale |
| Anakinra 200 mg | 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 | 48 hours | -43.6 Units on a scale |
| Anakinra 200 mg | 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 | 24 hours | -31.1 Units on a scale |
| Anakinra 200 mg | 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 | 72 hours | -49.1 Units on a scale |
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.
Time frame: at baseline, Day 8 and Day 15 for the first flare treated in the study
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 1 step | 8 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | No change | 20 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 2 steps | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 2 steps | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 1 steps | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 1 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | No change | 9 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | No change | 4 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 1 step | 12 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 2 step | 16 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Missing | 17 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 1 steps | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 3 step | 5 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 4 step | 3 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 2 step | 12 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 4 step | 3 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 3 step | 3 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Missing | 17 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 2 step | 15 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 1 step | 10 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 1 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | No change | 6 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 1 steps | 4 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 1 steps | 4 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 1 steps | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | No change | 6 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | No change | 26 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 1 step | 10 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 2 step | 10 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Missing | 14 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 3 step | 8 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 4 step | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 1 step | 5 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Missing | 17 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | No change | 23 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 2 step | 3 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 4 step | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 3 step | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 3 step | 3 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | No change | 14 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 4 step | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 2 step | 4 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 1 step | 7 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Missing | 17 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 1 step | 7 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Missing | 14 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | No change | 23 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Missing | 17 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 1 steps | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 2 step | 4 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 2 steps | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 4 step | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 1 steps | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | No change | 3 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 3 step | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 1 step | 5 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Missing | 14 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 3 step | 7 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 2 step | 17 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 4 step | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 1 steps | 3 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 3 step | 9 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 4 step | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 4 step | 1 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 4 step | 3 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 3 step | 5 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 2 step | 11 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 3 step | 2 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 1 step | 5 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Missing | 14 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 2 step | 5 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Missing | 14 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Triamcinolone 40 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 1 step | 8 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 2 step | 9 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 1 step | 18 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | No change | 7 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 1 steps | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 2 steps | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Missing | 9 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 4 step | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 3 step | 7 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 2 step | 10 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 1 step | 16 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | No change | 5 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 1 steps | 4 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 2 steps | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Missing | 12 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 4 step | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 3 step | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 2 step | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 1 step | 11 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | No change | 27 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 1 steps | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 2 steps | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Missing | 9 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 4 step | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 4 step | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 3 step | 6 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 3 step | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 2 step | 5 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 1 step | 10 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | No change | 21 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 1 steps | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 2 steps | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Missing | 12 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 4 step | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 3 step | 6 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 2 step | 11 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 1 step | 14 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | No change | 12 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 1 steps | 2 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 2 steps | 2 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Missing | 9 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 4 step | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 3 step | 7 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 2 step | 11 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 1 step | 12 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | No change | 9 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 1 steps | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 2 steps | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Missing | 12 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 4 step | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 3 step | 11 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 2 step | 12 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 1 step | 15 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | No change | 4 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 1 steps | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 2 steps | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Missing | 9 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 4 step | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 3 step | 11 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 2 step | 13 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 1 step | 11 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | No change | 2 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 1 steps | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 2 steps | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Missing | 12 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 4 step | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 3 step | 2 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 2 step | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 1 step | 9 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | No change | 33 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 1 steps | 3 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Missing | 9 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 4 step | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 3 step | 2 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 2 step | 1 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 1 step | 6 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | No change | 33 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 1 steps | 2 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 100 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Missing | 12 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 1 step | 10 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 2 step | 7 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Missing | 15 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 3 step | 1 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 3 step | 2 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Missing | 15 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 4 step | 1 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 3 step | 10 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Missing | 15 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 2 step | 14 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | No change | 9 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Improvement 1 step | 10 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 3 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | No change | 8 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Missing | 15 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 1 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Deterioration 1 steps | 1 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 2 step | 11 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | No change | 22 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 2 step | 3 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 1 step | 6 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 2 step | 7 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 15 | Missing | 11 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 3 step | 3 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Improvement 1 step | 10 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Self-care scores : Day 8 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 3 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Missing | 11 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 1 step | 12 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 2 step | 3 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | No change | 26 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Improvement 1 step | 9 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Missing | 15 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 3 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 2 step | 13 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | No change | 25 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Improvement 1 step | 13 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | No change | 14 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Deterioration 1 steps | 1 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Missing | 11 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 1 steps | 2 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | No change | 14 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 1 steps | 2 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 2 steps | 1 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 1 step | 9 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Deterioration 1 steps | 2 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 2 step | 13 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 15 | Deterioration 1 steps | 4 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 3 step | 2 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 15 | Missing | 11 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Usual activities scores : Day 8 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | No change | 14 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 4 step | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Missing | 11 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Improvement 3 step | 5 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 3 step | 11 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 2 step | 15 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 3 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 1 step | 10 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Improvement 1 step | 9 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 2 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 8 | Deterioration 1 steps | 2 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | No change | 4 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | Deterioration 1 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Anxiety/depression scores : Day 8 | Detorioration 4 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Pain/discomfort scores : Day 8 | Deterioration 1 steps | 0 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Selfcare scores : Day 15 | No change | 25 Participants |
| Anakinra 200 mg | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) | Mobility scores : Day 15 | Improvement 2 step | 15 Participants |
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.
Time frame: at baseline, Day 8 and Day 15 for the first flare treated in the study
Population: Some patients did not undertake all assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone 40 mg | Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | Day 8 | 8.0 units on a scale | Standard Deviation 9.8 |
| Triamcinolone 40 mg | Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | Day 15 | 11.8 units on a scale | Standard Deviation 8.2 |
| Anakinra 100 mg | Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | Day 8 | 10.5 units on a scale | Standard Deviation 10 |
| Anakinra 100 mg | Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | Day 15 | 12.2 units on a scale | Standard Deviation 11.9 |
| Anakinra 200 mg | Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | Day 8 | 10.4 units on a scale | Standard Deviation 8.3 |
| Anakinra 200 mg | Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score | Day 15 | 9.4 units on a scale | Standard Deviation 8.7 |
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
Time frame: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Population: Some patients did not undertake all assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone 40 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | Day 8 | -0.321 mg/dL | Standard Deviation 2.153 |
| Triamcinolone 40 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | 72 hours | -0.362 mg/dL | Standard Deviation 3.435 |
| Triamcinolone 40 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | Day 15 | -1.102 mg/dL | Standard Deviation 1.69 |
| Anakinra 100 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | Day 8 | -1.334 mg/dL | Standard Deviation 2.702 |
| Anakinra 100 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | 72 hours | -1.435 mg/dL | Standard Deviation 2.057 |
| Anakinra 100 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | Day 15 | -0.724 mg/dL | Standard Deviation 2.525 |
| Anakinra 200 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | 72 hours | -1.362 mg/dL | Standard Deviation 1.682 |
| Anakinra 200 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | Day 15 | -0.607 mg/dL | Standard Deviation 2.646 |
| Anakinra 200 mg | Change From Baseline in the Inflammatory Biomarker C Reactive Protein | Day 8 | 1.406 mg/dL | Standard Deviation 1.961 |
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
Time frame: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Population: Some patients did not undertake all assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone 40 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | Day 8 | -6.363 mg/L | Standard Deviation 117.794 |
| Triamcinolone 40 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | 72 hours | 8.950 mg/L | Standard Deviation 246.317 |
| Triamcinolone 40 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | Day 15 | -50.524 mg/L | Standard Deviation 105.17 |
| Anakinra 100 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | Day 8 | -46.561 mg/L | Standard Deviation 144.63 |
| Anakinra 100 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | 72 hours | -45.160 mg/L | Standard Deviation 126.986 |
| Anakinra 100 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | Day 15 | -25.328 mg/L | Standard Deviation 144.039 |
| Anakinra 200 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | 72 hours | -34.510 mg/L | Standard Deviation 58.518 |
| Anakinra 200 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | Day 15 | 14.370 mg/L | Standard Deviation 146.627 |
| Anakinra 200 mg | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A | Day 8 | -35.887 mg/L | Standard Deviation 64.144 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone 40 mg | 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 | Day 5 | -1.8 Score on a scale | Standard Deviation 1.1 |
| Triamcinolone 40 mg | 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 | 36 hours | -1.3 Score on a scale | Standard Deviation 0.8 |
| Triamcinolone 40 mg | 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 | Day 7 | -2.4 Score on a scale | Standard Deviation 0.8 |
| Triamcinolone 40 mg | 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 | 72 hours | -1.6 Score on a scale | Standard Deviation 1.1 |
| Triamcinolone 40 mg | 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 | 48 hours | -1.5 Score on a scale | Standard Deviation 1 |
| Triamcinolone 40 mg | 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 | 6 hours | -0.6 Score on a scale | Standard Deviation 0.7 |
| Triamcinolone 40 mg | 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 | 18 hours | -0.8 Score on a scale | Standard Deviation 0.8 |
| Triamcinolone 40 mg | 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 | 12 hours | -0.9 Score on a scale | Standard Deviation 0.6 |
| Triamcinolone 40 mg | 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 | Day 6 | -1.9 Score on a scale | Standard Deviation 1.1 |
| Triamcinolone 40 mg | 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 | 24 hours | -1.0 Score on a scale | Standard Deviation 0.8 |
| Triamcinolone 40 mg | 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 | Day 8 | -1.9 Score on a scale | Standard Deviation 0.9 |
| Anakinra 100 mg | 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 | 48 hours | -1.4 Score on a scale | Standard Deviation 1 |
| Anakinra 100 mg | 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 | 6 hours | -0.8 Score on a scale | Standard Deviation 0.9 |
| Anakinra 100 mg | 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 | 12 hours | -1.1 Score on a scale | Standard Deviation 1.2 |
| Anakinra 100 mg | 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 | 18 hours | -1.2 Score on a scale | Standard Deviation 1 |
| Anakinra 100 mg | 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 | 24 hours | -0.9 Score on a scale | Standard Deviation 1 |
| Anakinra 100 mg | 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 | 36 hours | -1.3 Score on a scale | Standard Deviation 1 |
| Anakinra 100 mg | 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 | 72 hours | -1.6 Score on a scale | Standard Deviation 1 |
| Anakinra 100 mg | 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 | Day 5 | -1.8 Score on a scale | Standard Deviation 1.1 |
| Anakinra 100 mg | 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 | Day 6 | -2.2 Score on a scale | Standard Deviation 1.1 |
| Anakinra 100 mg | 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 | Day 7 | -2.2 Score on a scale | Standard Deviation 1.1 |
| Anakinra 100 mg | 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 | Day 8 | -2.1 Score on a scale | Standard Deviation 1.1 |
| Anakinra 200 mg | 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 | Day 7 | -1.9 Score on a scale | Standard Deviation 1 |
| Anakinra 200 mg | 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 | Day 5 | -1.8 Score on a scale | Standard Deviation 1.1 |
| Anakinra 200 mg | 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 | 18 hours | -0.8 Score on a scale | Standard Deviation 0.9 |
| Anakinra 200 mg | 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 | 6 hours | -0.4 Score on a scale | Standard Deviation 0.8 |
| Anakinra 200 mg | 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 | Day 6 | -1.9 Score on a scale | Standard Deviation 1 |
| Anakinra 200 mg | 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 | 12 hours | -0.5 Score on a scale | Standard Deviation 0.7 |
| Anakinra 200 mg | 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 | 48 hours | -1.5 Score on a scale | Standard Deviation 1 |
| Anakinra 200 mg | 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 | 36 hours | -1.1 Score on a scale | Standard Deviation 0.7 |
| Anakinra 200 mg | 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 | Day 8 | -2.1 Score on a scale | Standard Deviation 1 |
| Anakinra 200 mg | 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 | 72 hours | -1.7 Score on a scale | Standard Deviation 0.9 |
| Anakinra 200 mg | 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 | 24 hours | -1.1 Score on a scale | Standard Deviation 0.9 |
Secondary
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits
Time frame: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period
Population: Some patients did not undertake all assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitsFourth flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Second flare:Day 1-15 | 0.5 days | Standard Deviation 1.5 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Second flare:Day 8-15 | 0.2 days | Standard Deviation 0.6 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitFifth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Second flare:Day 1-7 | 0.2 days | Standard Deviation 0.8 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitsFourth flare:Day 8-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare:Day 1-15 | 0.4 days | Standard Deviation 1.4 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare:Day 8-15 | 0.3 days | Standard Deviation 1.4 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare: Day 1-7 | 0.1 days | Standard Deviation 0.5 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitstFourth flare:Day 1-7 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 1-15 | 0.8 days | Standard Deviation 1.8 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Fifth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 8-15 | 0.4 days | Standard Deviation 0.9 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit Fifth flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Triamcinolone 40 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 1-7 | 0.4 days | Standard Deviation 0.9 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare: Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare:Day 8-15 | 0.1 days | Standard Deviation 0.6 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare:Day 1-15 | 0.1 days | Standard Deviation 0.6 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Second flare:Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Second flare:Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Second flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitstFourth flare:Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitsFourth flare:Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitsFourth flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Fifth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitFifth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 100 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit Fifth flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Second flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Third flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Fifth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Third flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : First flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitstFourth flare:Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit Fifth flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare: Day 1-7 | 0.1 days | Standard Deviation 0.6 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitsFourth flare:Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare:Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Second flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:First flare:Day 1-15 | 0.1 days | Standard Deviation 0.6 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fifth flare : Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitFifth flare : Day 8-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visits:Second flare:Day 1-7 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Hospitalization : Fourth flare : Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visitsFourth flare:Day 1-15 | 0 days | Standard Deviation 0 |
| Anakinra 200 mg | Health Care Resource Utilization Due to a Gouty Arthritis Flare | Unscheduled outpatient visit:Second flare:Day 8-15 | 0 days | Standard Deviation 0 |
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
Time frame: From Day 1 to Day 15 for the first flare treated
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Triamcinolone 40 mg | Median Time to First Intake of Rescue Medication From First Investigational Drug Administration | NA Hours |
| Anakinra 100 mg | Median Time to First Intake of Rescue Medication From First Investigational Drug Administration | NA Hours |
| Anakinra 200 mg | Median Time to First Intake of Rescue Medication From First Investigational Drug Administration | NA Hours |
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)
Time frame: From baseline (predose) up to Day15 of the first flare treated in the study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Triamcinolone 40 mg | Median Time to Onset of Effect | 22.3 Hours |
| Anakinra 100 mg | Median Time to Onset of Effect | 11.8 Hours |
| Anakinra 200 mg | Median Time to Onset of Effect | 19.8 Hours |
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
Time frame: From baseline (predose) up to Day15 of the first flare
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Triamcinolone 40 mg | Median Time to Resolution of Pain | 167.5 Hours |
| Anakinra 100 mg | Median Time to Resolution of Pain | 131.8 Hours |
| Anakinra 200 mg | Median Time to Resolution of Pain | 119.8 Hours |
Secondary
Median Time to Response
Response defined as 50% change from baseline pain intensity on a visual analogue scale (VAS)
Time frame: From baseline (predose) up to Day15 of the first flare treated in the study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Triamcinolone 40 mg | Median Time to Response | 47.6 Hours |
| Anakinra 100 mg | Median Time to Response | 43.0 Hours |
| Anakinra 200 mg | Median Time to Response | 46.9 Hours |
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
Time frame: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Poor | 4 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Very good | 13 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Good | 7 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Fair | 7 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Excellent | 11 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Missing | 13 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Excellent | 9 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Very good | 16 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Good | 8 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Fair | 5 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Poor | 5 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Missing | 12 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Excellent | 14 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Very good | 9 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Good | 10 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Fair | 6 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Poor | 3 Participants |
| Triamcinolone 40 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Missing | 13 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Missing | 11 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Excellent | 10 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Fair | 6 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Excellent | 19 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Very good | 19 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Good | 8 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Fair | 5 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Good | 14 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Poor | 0 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Poor | 0 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Fair | 4 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Good | 6 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Very good | 13 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Poor | 1 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Very good | 21 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Missing | 7 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Missing | 8 Participants |
| Anakinra 100 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Excellent | 16 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Missing | 8 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Excellent | 19 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Very good | 13 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Good | 10 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Good | 7 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Missing | 8 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Fair | 2 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Poor | 1 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Fair | 3 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 8 : Missing | 12 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Excellent | 18 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Very good | 9 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Excellent | 21 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Good | 15 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Fair | 3 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | 72 hours : Poor | 1 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Very good | 11 Participants |
| Anakinra 200 mg | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) | Day 15 : Poor | 1 Participants |
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.
Time frame: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period
Population: Some patients did not undertake all assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Second flare : Day 15 | 16.0 percent | Standard Deviation 25.1 |
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Fifth flare : Day 15 | 20.0 percent | — |
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Third flare : Day 15 | 10.0 percent | — |
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Third flare : Day 8 | 10.0 percent | — |
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | First flare : Day 8 | 36.1 percent | Standard Deviation 34.3 |
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Fifth flare : Day 8 | 60.0 percent | — |
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Second flare : Day 8 | 42.9 percent | Standard Deviation 27.5 |
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | First flare : Day 15 | 23.3 percent | Standard Deviation 24.8 |
| Triamcinolone 40 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Fourth flare : Day 8 | 30.0 percent | — |
| Anakinra 100 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Third flare : Day 8 | 5.0 percent | Standard Deviation 7.1 |
| Anakinra 100 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | First flare : Day 8 | 32.6 percent | Standard Deviation 29.1 |
| Anakinra 100 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | First flare : Day 15 | 12.6 percent | Standard Deviation 20.7 |
| Anakinra 100 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Second flare : Day 8 | 24.0 percent | Standard Deviation 26.3 |
| Anakinra 100 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Second flare : Day 15 | 20.0 percent | Standard Deviation 17.6 |
| Anakinra 100 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Third flare : Day 15 | 20.0 percent | Standard Deviation 24.5 |
| Anakinra 100 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Fifth flare : Day 15 | 40.0 percent | — |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Fifth flare : Day 15 | 13.3 percent | Standard Deviation 11.5 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Third flare : Day 15 | 23.3 percent | Standard Deviation 32.1 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Second flare : Day 8 | 24.0 percent | Standard Deviation 27.2 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Fourth flare : Day 8 | 20.0 percent | Standard Deviation 34.6 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Fourth flare : Day 15 | 5.0 percent | Standard Deviation 7.1 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | First flare : Day 15 | 21.6 percent | Standard Deviation 22.3 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Fifth flare : Day 8 | 26.7 percent | Standard Deviation 25.2 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | First flare : Day 8 | 20.5 percent | Standard Deviation 25 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Third flare : Day 8 | 10.0 percent | Standard Deviation 10 |
| Anakinra 200 mg | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares | Second flare : Day 15 | 13.8 percent | Standard Deviation 16.9 |
Secondary
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Physicians assessment of clinical signs with 2 outcomes: Absent=no erythema, present=erythema
Time frame: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Present | 51 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Present | 22 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Absent | 29 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Present | 2 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Missing | 4 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Absent | 3 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Absent | 47 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Absent | 43 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Missing | 6 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Missing | 1 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Present | 6 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Missing | 6 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Present | 9 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Missing | 4 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Absent | 47 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Present | 5 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Absent | 39 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Missing | 4 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Present | 14 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Present | 48 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Missing | 3 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Absent | 8 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Absent | 43 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Missing | 0 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Missing | 5 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Absent | 8 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Present | 45 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Baseline : Missing | 1 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Absent | 37 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Present | 14 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | 72 hours : Missing | 3 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Absent | 40 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Present | 9 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 8 : Missing | 5 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Absent | 40 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Erythema | Day 15 : Present | 9 Participants |
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)
Time frame: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Missing | 6 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Moderate | 10 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : None | 0 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Severe | 1 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Severe | 5 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Severe | 23 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Moderate | 7 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Missing | 4 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Missing | 6 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Mild | 16 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : None | 25 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Moderate | 2 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Missing | 0 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Severe | 1 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Mild | 9 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : None | 14 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Moderate | 23 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : None | 37 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Mild | 22 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Mild | 9 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Moderate | 3 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : None | 0 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Mild | 14 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Moderate | 27 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Severe | 15 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Missing | 0 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : None | 27 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Mild | 18 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Moderate | 7 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Severe | 1 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Missing | 3 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : None | 37 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Mild | 13 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Moderate | 2 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Severe | 1 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Missing | 3 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : None | 44 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Mild | 6 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Severe | 0 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Missing | 3 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Mild | 7 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Severe | 0 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Mild | 26 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Missing | 5 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Missing | 5 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : None | 17 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Severe | 0 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : None | 34 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Missing | 1 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : None | 0 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Mild | 14 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Severe | 18 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : None | 38 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Missing | 3 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Baseline : Moderate | 28 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Mild | 9 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Severe | 1 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 15 : Moderate | 1 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | Day 8 : Moderate | 2 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Swelling | 72 hours : Moderate | 7 Participants |
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
Time frame: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : None | 19 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Moderate | 17 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : None | 37 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Mild | 25 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Mild | 22 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Missing | 6 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Moderate | 4 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Moderate | 1 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Severe | 1 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Severe | 4 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Missing | 6 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : None | 8 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Missing | 4 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Severe | 1 Participants |
| Triamcinolone 40 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Mild | 10 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Mild | 9 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : None | 18 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Mild | 28 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Moderate | 4 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Severe | 3 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Missing | 3 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : None | 28 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Mild | 19 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Moderate | 2 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Severe | 4 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Missing | 3 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : None | 38 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Moderate | 5 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Severe | 1 Participants |
| Anakinra 100 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Missing | 3 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : None | 30 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Severe | 0 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : None | 32 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Missing | 3 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Severe | 1 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Mild | 12 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Moderate | 9 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : None | 16 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Moderate | 5 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Moderate | 1 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | 72 hours : Mild | 25 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Severe | 1 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Mild | 17 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 15 : Missing | 5 Participants |
| Anakinra 200 mg | Physician's Assessment of Clinical Signs in Index Joint: Tenderness | Day 8 : Missing | 5 Participants |
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
Time frame: At 72 hours, Day 8 and Day 15 for the first flare treated in the study
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Triamcinolone 40 mg | Physician's Assessment of Global Response to Treatment | Day 15 | 1.04 Score on a scale |
| Triamcinolone 40 mg | Physician's Assessment of Global Response to Treatment | Day 8 | 1.26 Score on a scale |
| Triamcinolone 40 mg | Physician's Assessment of Global Response to Treatment | 72 hours | 1.54 Score on a scale |
| Anakinra 100 mg | Physician's Assessment of Global Response to Treatment | Day 15 | 0.80 Score on a scale |
| Anakinra 100 mg | Physician's Assessment of Global Response to Treatment | 72 hours | 1.25 Score on a scale |
| Anakinra 100 mg | Physician's Assessment of Global Response to Treatment | Day 8 | 0.90 Score on a scale |
| Anakinra 200 mg | Physician's Assessment of Global Response to Treatment | Day 8 | 0.81 Score on a scale |
| Anakinra 200 mg | Physician's Assessment of Global Response to Treatment | 72 hours | 1.25 Score on a scale |
| Anakinra 200 mg | Physician's Assessment of Global Response to Treatment | Day 15 | 0.78 Score on a scale |
Secondary
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Time frame: 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
Population: Some patients did not undertake all assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Baseline | 2 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 8 | 1 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 28 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Baseline | 5 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 8 | 4 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 15 | 5 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 28 | 4 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Week 12 | 4 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 8 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 15 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 28 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Week 12 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 8 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 15 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 28 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Week 12 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 8 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 15 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 28 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Week 12 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 8 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 15 | 2 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 28 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 8 | 3 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 15 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Baseline | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 15 | 4 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 8 | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 15 | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Day 28 | 1 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Baseline | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 8 | 3 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Baseline | 1 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 28 | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 15 | 4 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 28 | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 28 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Day 8 | 4 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fifth flare : Day 8 | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Third flare : Baseline | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Week 12 | 1 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Fourth flare : Baseline | 2 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | Second flare : Day 28 | 1 participants |
| Anakinra 200 mg | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra | First flare : Day 15 | 4 participants |
Secondary
Proportion of Patients With Neutralizing Antibodies
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Time frame: 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
Population: Some patients did not undertake all assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Study baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Flare baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Flare baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Study baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Study baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Flare baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Flare baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Study baseline | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 8 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Week 12 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 15 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 28 | 0 participants |
| Triamcinolone 40 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Week 12 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 8 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 8 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 15 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 28 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Week 12 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Study baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Flare baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 8 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 15 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 28 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Week 12 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Study baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Flare baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 8 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 15 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 28 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Week 12 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Study baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Flare baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 8 | 1 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 15 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 28 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Week 12 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Study baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Flare baseline | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 15 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 28 | 0 participants |
| Anakinra 100 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 15 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 8 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 28 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 15 | 1 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 15 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 15 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Day 28 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Day 8 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 8 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Flare baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Study baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Study baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 28 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 15 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Flare baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 28 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Day 8 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Week 12 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Flare baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | First flare : Day 28 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Study baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Third flare : Study baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fifth flare : Day 8 | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Fourth flare : Flare baseline | 0 participants |
| Anakinra 200 mg | Proportion of Patients With Neutralizing Antibodies | Second flare : Week 12 | 0 participants |
Secondary
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra
Time frame: 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
Population: Some patients did not undertake all assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 28 | 1.975 ng/mL | Standard Deviation 1.714 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifth flare : Week 12 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : 72 hours | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Week 12 | 2.920 ng/mL | Standard Deviation 4.49 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 8 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Baseline | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Baseline | 2.05 ng/mL | Standard Deviation 1.24 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 28 | 1.635 ng/mL | Standard Deviation 0.615 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Week 12 | 2.85 ng/mL | Standard Deviation 1.91 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : 72 hours | 1.85 ng/mL | Standard Deviation 0.78 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 28 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 28 | 1.85 ng/mL | Standard Deviation 0.78 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 8 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : 72 hours | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 15 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Week 12 | 1.500 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 8 | 1.692 ng/mL | Standard Deviation 1.343 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifth flare : Baseline | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Baseline | 1.748 ng/mL | Standard Deviation 1.024 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : 72 hours | 1.974 ng/mL | Standard Deviation 1.793 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Week 12 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : 72 hours | 1.628 ng/mL | Standard Deviation 0.526 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Baseline | 2.032 ng/mL | Standard Deviation 2.493 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 28 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 8 | 3.141 ng/mL | Standard Deviation 6.27 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 15 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 15 | 1.50 ng/mL | Standard Deviation 0 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 15 | 1.845 ng/mL | Standard Deviation 1291 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 15 | 1.533 ng/mL | Standard Deviation 0.226 |
| Triamcinolone 40 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 8 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : 72 hours | 254.930 ng/mL | Standard Deviation 249.962 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Baseline | 4.883 ng/mL | Standard Deviation 24.378 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : 72 hours | 267.744 ng/mL | Standard Deviation 246.086 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 8 | 6.750 ng/mL | Standard Deviation 10.439 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 15 | 1.588 ng/mL | Standard Deviation 0.443 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 28 | 1.659 ng/mL | Standard Deviation 1.057 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Week 12 | 1.625 ng/mL | Standard Deviation 0.478 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Baseline | 1.718 ng/mL | Standard Deviation 0.732 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 8 | 7.048 ng/mL | Standard Deviation 20.338 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 15 | 1.595 ng/mL | Standard Deviation 0.457 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 28 | 1.692 ng/mL | Standard Deviation 0.882 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Week 12 | 1.681 ng/mL | Standard Deviation 0.725 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Baseline | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : 72 hours | 196.67 ng/mL | Standard Deviation 192.56 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 8 | 5.56 ng/mL | Standard Deviation 12.97 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 15 | 1.63 ng/mL | Standard Deviation 0.44 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 28 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Week 12 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Baseline | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : 72 hours | 184.40 ng/mL | Standard Deviation 198.19 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 8 | 1.89 ng/mL | Standard Deviation 1.02 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 15 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 28 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Week 12 | 2.66 ng/mL | Standard Deviation 2.6 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifth flare : Baseline | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : 72 hours | 129.20 ng/mL | Standard Deviation 200.26 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 8 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 15 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 100 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 28 | 3.31 ng/mL | Standard Deviation 2.55 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : 72 hours | 916.62 ng/mL | Standard Deviation 1549.55 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 15 | 1.500 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 8 | 6.39 ng/mL | Standard Deviation 9.49 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 8 | 20.62 ng/mL | Standard Deviation 34.1 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 8 | 48.785 ng/mL | Standard Deviation 114.114 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 8 | 34.777 ng/mL | Standard Deviation 87.812 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 15 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : 72 hours | 719.667 ng/mL | Standard Deviation 840.53 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Baseline | 1.950 ng/mL | Standard Deviation 2.755 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Day 28 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Baseline | 1.500 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 15 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Week 12 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Week 12 | 1.719 ng/mL | Standard Deviation 0.681 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : 72 hours | 628.053 ng/mL | Standard Deviation 540.488 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifth flare : Baseline | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 8 | 10.70 ng/mL | Standard Deviation 15.42 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 28 | 1.779 ng/mL | Standard Deviation 0.895 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 15 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : 72 hours | 431.63 ng/mL | Standard Deviation 298.51 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifth flare : Week 12 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Day 28 | 2.47 ng/mL | Standard Deviation 2.38 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Baseline | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : 72 hours | 292.35 ng/mL | Standard Deviation 308.56 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Third flare : Week 12 | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Week 12 | 1.692 ng/mL | Standard Deviation 0.636 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | First flare : Day 15 | 1.574 ng/mL | Standard Deviation 0.356 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fourth flare : Baseline | 1.50 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Second flare : Day 28 | 1.500 ng/mL | Standard Deviation 0 |
| Anakinra 200 mg | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra | Fifthe flare : Day 28 | 1.50 ng/mL | Standard Deviation 0 |
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.
Time frame: Through study completion, at 12 weeks after last flare treated during the extension period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Triamcinolone 40 mg | The Percent of Patients With at Least One Adverse Event | 40.7 Percent |
| Anakinra 100 mg | The Percent of Patients With at Least One Adverse Event | 38.2 Percent |
| Anakinra 200 mg | The Percent of Patients With at Least One Adverse Event | 55.8 Percent |
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.
Time frame: Through study completion, at 12 weeks after last flare treated during the extension period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Triamcinolone 40 mg | The Percent of Patients With at Least One Serious Adverse Event, Including Death | 0 Percent |
| Anakinra 100 mg | The Percent of Patients With at Least One Serious Adverse Event, Including Death | 7.3 Percent |
| Anakinra 200 mg | The Percent of Patients With at Least One Serious Adverse Event, Including Death | 0 Percent |