anaGO: A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis
Sponsor
Swedish Orphan Biovitrum (Industry)
Overall Status
Completed
CT.gov ID
NCT03002974
Collaborator
(none)
165
37
3
32
4.5
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Active-control, Multicenter, Efficacy and Safety Study of 2 Dose Levels of Subcutaneous Anakinra Compared to Intramuscular Triamcinolone in the Treatment of Acute Gouty Arthritis, Followed by an Extension Period of up to 2 Years
Actual Study Start Date
:
Dec 1, 2016
Actual Primary Completion Date
:
Jun 1, 2018
Actual Study Completion Date
:
Aug 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: Anakinra 100 mg
100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Other Names:
Drug: Placebo to Anakinra 100 mg
sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Other Names:
Drug: Placebo to Triamcinolone Acetonide 40 mg
1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
Other Names:
|
| Experimental: 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 |
Drug: Anakinra 100 mg
100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Other Names:
Drug: Placebo to Triamcinolone Acetonide 40 mg
1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
Other Names:
|
| Active Comparator: 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 |
Drug: Triamcinolone Acetonide 40 mg
1 mL intramuscular injection of a 40 mg/mL injectable suspension
Other Names:
Drug: Placebo to Anakinra 100 mg
sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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 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
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Exclusion criteria for treatment of subsequent flare(s):
-
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 CKD stages 4 and 5
-
Presence of neutropenia
-
History of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting, 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.
-
Pregnant or lactating women.
-
Presence of any condition or laboratory result that in the opinion of the investigator makes the patient not appropriate for treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Fundamental Research, LLC | Gulf Shores | Alabama | United States | 36542 |
| 3 | Coastal Clinical Research, Inc | Mobile | Alabama | United States | 36608 |
| 4 | Advanced Research Center | Anaheim | California | United States | 92805 |
| 5 | Delta Waves Sleep Disorder and Research Center | Colorado Springs | Colorado | United States | 80918 |
| 6 | Pulmonary Associates of Brandon | Brandon | Florida | United States | 33511 |
| 7 | Meridien Research | Brooksville | Florida | United States | 34601 |
| 8 | Health Awareness | Jupiter | Florida | United States | 33458 |
| 9 | Well Pharma Medical Research | Miami | Florida | United States | 33143 |
| 10 | Clinical Neuroscience Solutions | Orlando | Florida | United States | 32801 |
| 11 | Clinical Research Trials of Florida | Tampa | Florida | United States | 33607 |
| 12 | Meridien Research, Inc | Tampa | Florida | United States | 33634 |
| 13 | Kaushik Amin MD | Conyers | Georgia | United States | 30013 |
| 14 | Alta Pharmaceutical Research Center | Dunwoody | Georgia | United States | 30338 |
| 15 | Lemah Creek Clinical Research | Melrose Park | Illinois | United States | 60160 |
| 16 | The Research Group of Lexington | Lexington | Kentucky | United States | 40503 |
| 17 | Clinical Trials Management | Metairie | Louisiana | United States | 70006 |
| 18 | University of Michigan | Ann Arbor | Michigan | United States | 48109-5422 |
| 19 | Albuquerque Clinical Trials | Albuquerque | New Mexico | United States | 87102 |
| 20 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 21 | Boiling Springs Medical Research, Inc. | Shelby | North Carolina | United States | 28150 |
| 22 | PMG Research of Winston-Salem | Winston-Salem | North Carolina | United States | 27103 |
| 23 | Hightop Medical Research Center | Cincinnati | Ohio | United States | 45224 |
| 24 | New Horizons Clinical Research | Cincinnati | Ohio | United States | 45242 |
| 25 | Clinical Research Solutions - Franklin | Franklin | Tennessee | United States | 37067 |
| 26 | Clinical Research Solutions | Smyrna | Tennessee | United States | 37167 |
| 27 | Renaissance Clinical Research and Hypertension Clinic of Texas, PLLC | Dallas | Texas | United States | 75234 |
| 28 | Pioneer Research Solutions, Inc. | Houston | Texas | United States | 77099 |
| 29 | Accurate Clinical Management | Pasadena | Texas | United States | 77505 |
| 30 | Sun Research Institute | San Antonio | Texas | United States | 78215 |
| 31 | Wade Family Medicine | Bountiful | Utah | United States | 84010 |
| 32 | Ericksen Research & Development | Clinton | Utah | United States | 84015 |
| 33 | Advanced Clinical Research - West Jordan | West Jordan | Utah | United States | 84088 |
| 34 | Commonwealth Clinical Research Specialists, Inc. | Richmond | Virginia | United States | 23235 |
| 35 | Corporation Lane Internal Medicine and Research Center | Virginia Beach | Virginia | United States | 23462 |
| 36 | Mileground Physicians, PLLC | Morgantown | West Virginia | United States | 26505 |
| 37 | Clinical Investigations Specialists, Inc. | Kenosha | Wisconsin | United States | 53142 |
Sponsors and Collaborators
- Swedish Orphan Biovitrum
Investigators
- Study Director: Sven Ohlman, MD, PhD, Swedish Orphan Biovitrum AB
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT03002974
Other Study ID Numbers:
- Sobi.ANAKIN-401
First Posted:
Dec 26, 2016
Last Update Posted:
Jul 15, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Swedish Orphan Biovitrum
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Period Title: Overall Study | |||
| STARTED | 55 | 56 | 54 |
| Intention To Treat Populatio | 55 | 56 | 54 |
| Safety Population | 54 | 55 | 52 |
| COMPLETED | 35 | 40 | 36 |
| NOT COMPLETED | 20 | 16 | 18 |
Baseline Characteristics
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | Total of all reporting groups |
| Overall Participants | 55 | 56 | 54 | 165 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
56.8
(10.3)
|
53.7
(11.9)
|
54.0
(13.1)
|
54.8
(11.8)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
7
12.7%
|
8
14.3%
|
7
13%
|
22
13.3%
|
| Male |
48
87.3%
|
48
85.7%
|
47
87%
|
143
86.7%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
39
70.9%
|
38
67.9%
|
42
77.8%
|
119
72.1%
|
| Black or African American |
15
27.3%
|
15
26.8%
|
12
22.2%
|
42
25.5%
|
| Asian |
1
1.8%
|
3
5.4%
|
0
0%
|
4
2.4%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
55
100%
|
56
100%
|
54
100%
|
165
100%
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| 24 hours |
-26.1
|
-32.5
|
-31.1
|
| 48 hours |
-43.4
|
-42.9
|
-43.6
|
| 72 hours |
-45.2
|
-51.6
|
-49.1
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| 6 hours |
-0.6
(0.7)
|
-0.8
(0.9)
|
-0.4
(0.8)
|
| 12 hours |
-0.9
(0.6)
|
-1.1
(1.2)
|
-0.5
(0.7)
|
| 18 hours |
-0.8
(0.8)
|
-1.2
(1.0)
|
-0.8
(0.9)
|
| 24 hours |
-1.0
(0.8)
|
-0.9
(1.0)
|
-1.1
(0.9)
|
| 36 hours |
-1.3
(0.8)
|
-1.3
(1.0)
|
-1.1
(0.7)
|
| 48 hours |
-1.5
(1.0)
|
-1.4
(1.0)
|
-1.5
(1.0)
|
| 72 hours |
-1.6
(1.1)
|
-1.6
(1.0)
|
-1.7
(0.9)
|
| Day 5 |
-1.8
(1.1)
|
-1.8
(1.1)
|
-1.8
(1.1)
|
| Day 6 |
-1.9
(1.1)
|
-2.2
(1.1)
|
-1.9
(1.0)
|
| Day 7 |
-2.4
(0.8)
|
-2.2
(1.1)
|
-1.9
(1.0)
|
| Day 8 |
-1.9
(0.9)
|
-2.1
(1.1)
|
-2.1
(1.0)
|
| Title | Median Time to Onset of Effect |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| Median (95% Confidence Interval) [Hours] |
22.3
|
11.8
|
19.8
|
| Title | Median Time to Response |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| Median (95% Confidence Interval) [Hours] |
47.6
|
43.0
|
46.9
|
| Title | Median Time to Resolution of Pain |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| Median (95% Confidence Interval) [Hours] |
167.5
|
131.8
|
119.8
|
| Title | Median Time to First Intake of Rescue Medication From First Investigational Drug Administration |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 25 | 26 | 22 |
| Median (95% Confidence Interval) [Hours] |
NA
|
NA
|
NA
|
| Title | Physician's Assessment of Global Response to Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| 72 hours |
1.54
|
1.25
|
1.25
|
| Day 8 |
1.26
|
0.90
|
0.81
|
| Day 15 |
1.04
|
0.80
|
0.78
|
| Title | Physician's Assessment of Clinical Signs in Index Joint: Tenderness |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| 72 hours : None |
8
14.5%
|
18
32.1%
|
16
29.6%
|
| 72 hours : Mild |
22
40%
|
28
50%
|
25
46.3%
|
| 72 hours : Moderate |
17
30.9%
|
4
7.1%
|
9
16.7%
|
| 72 hours : Severe |
4
7.3%
|
3
5.4%
|
1
1.9%
|
| 72 hours : Missing |
4
7.3%
|
3
5.4%
|
3
5.6%
|
| Day 8 : None |
19
34.5%
|
28
50%
|
30
55.6%
|
| Day 8 : Mild |
25
45.5%
|
19
33.9%
|
17
31.5%
|
| Day 8 : Moderate |
4
7.3%
|
2
3.6%
|
1
1.9%
|
| Day 8 : Severe |
1
1.8%
|
4
7.1%
|
1
1.9%
|
| Day 8 : Missing |
6
10.9%
|
3
5.4%
|
5
9.3%
|
| Day 15 : None |
37
67.3%
|
38
67.9%
|
32
59.3%
|
| Day 15 : Mild |
10
18.2%
|
9
16.1%
|
12
22.2%
|
| Day 15 : Moderate |
1
1.8%
|
5
8.9%
|
5
9.3%
|
| Day 15 : Severe |
1
1.8%
|
1
1.8%
|
0
0%
|
| Day 15 : Missing |
6
10.9%
|
3
5.4%
|
5
9.3%
|
| Title | Physician's Assessment of Clinical Signs in Index Joint: Swelling |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| Baseline : None |
0
0%
|
0
0%
|
0
0%
|
| Baseline : Mild |
9
16.4%
|
14
25%
|
7
13%
|
| Baseline : Moderate |
23
41.8%
|
27
48.2%
|
28
51.9%
|
| Baseline : Severe |
23
41.8%
|
15
26.8%
|
18
33.3%
|
| Baseline : Missing |
0
0%
|
0
0%
|
1
1.9%
|
| 72 hours : None |
14
25.5%
|
27
48.2%
|
17
31.5%
|
| 72 hours : Mild |
22
40%
|
18
32.1%
|
26
48.1%
|
| 72 hours : Moderate |
10
18.2%
|
7
12.5%
|
7
13%
|
| 72 hours : Severe |
5
9.1%
|
1
1.8%
|
1
1.9%
|
| 72 hours : Missing |
4
7.3%
|
3
5.4%
|
3
5.6%
|
| Day 8 : None |
25
45.5%
|
37
66.1%
|
38
70.4%
|
| Day 8 : Mild |
16
29.1%
|
13
23.2%
|
9
16.7%
|
| Day 8 : Moderate |
7
12.7%
|
2
3.6%
|
2
3.7%
|
| Day 8 : Severe |
1
1.8%
|
1
1.8%
|
0
0%
|
| Day 8 : Missing |
6
10.9%
|
3
5.4%
|
5
9.3%
|
| Day 15 : None |
37
67.3%
|
44
78.6%
|
34
63%
|
| Day 15 : Mild |
9
16.4%
|
6
10.7%
|
14
25.9%
|
| Day 15 : Moderate |
2
3.6%
|
3
5.4%
|
1
1.9%
|
| Day 15 : Severe |
1
1.8%
|
0
0%
|
0
0%
|
| Day 15 : Missing |
6
10.9%
|
3
5.4%
|
5
9.3%
|
| Title | Physician's Assessment of Clinical Signs in Index Joint: Erythema |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| Baseline : Absent |
3
5.5%
|
8
14.3%
|
8
14.8%
|
| Baseline : Present |
51
92.7%
|
48
85.7%
|
45
83.3%
|
| Baseline : Missing |
1
1.8%
|
0
0%
|
1
1.9%
|
| 72 hours : Absent |
29
52.7%
|
39
69.6%
|
37
68.5%
|
| 72 hours : Present |
22
40%
|
14
25%
|
14
25.9%
|
| 72 hours : Missing |
4
7.3%
|
3
5.4%
|
3
5.6%
|
| Day 8 : Absent |
43
78.2%
|
43
76.8%
|
40
74.1%
|
| Day 8 : Present |
6
10.9%
|
9
16.1%
|
9
16.7%
|
| Day 8 : Missing |
6
10.9%
|
4
7.1%
|
5
9.3%
|
| Day 15 : Absent |
47
85.5%
|
47
83.9%
|
40
74.1%
|
| Day 15 : Present |
2
3.6%
|
5
8.9%
|
9
16.7%
|
| Day 15 : Missing |
6
10.9%
|
4
7.1%
|
5
9.3%
|
| Title | Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| 72 hours : Excellent |
11
20%
|
10
17.9%
|
18
33.3%
|
| 72 hours : Very good |
13
23.6%
|
19
33.9%
|
9
16.7%
|
| 72 hours : Good |
7
12.7%
|
14
25%
|
15
27.8%
|
| 72 hours : Fair |
7
12.7%
|
4
7.1%
|
3
5.6%
|
| 72 hours : Poor |
4
7.3%
|
1
1.8%
|
1
1.9%
|
| 72 hours : Missing |
13
23.6%
|
8
14.3%
|
8
14.8%
|
| Day 8 : Excellent |
9
16.4%
|
16
28.6%
|
19
35.2%
|
| Day 8 : Very good |
16
29.1%
|
21
37.5%
|
13
24.1%
|
| Day 8 : Good |
8
14.5%
|
6
10.7%
|
7
13%
|
| Day 8 : Fair |
5
9.1%
|
6
10.7%
|
2
3.7%
|
| Day 8 : Poor |
5
9.1%
|
0
0%
|
1
1.9%
|
| Day 8 : Missing |
12
21.8%
|
7
12.5%
|
12
22.2%
|
| Day 15 : Excellent |
14
25.5%
|
19
33.9%
|
21
38.9%
|
| Day 15 : Very good |
9
16.4%
|
13
23.2%
|
11
20.4%
|
| Day 15 : Good |
10
18.2%
|
8
14.3%
|
10
18.5%
|
| Day 15 : Fair |
6
10.9%
|
5
8.9%
|
3
5.6%
|
| Day 15 : Poor |
3
5.5%
|
0
0%
|
1
1.9%
|
| Day 15 : Missing |
13
23.6%
|
11
19.6%
|
8
14.8%
|
| Title | Change From Baseline in the Inflammatory Biomarker C Reactive Protein |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some patients did not undertake all assessments. |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| 72 hours |
-0.362
(3.435)
|
-1.435
(2.057)
|
-1.362
(1.682)
|
| Day 8 |
-0.321
(2.153)
|
-1.334
(2.702)
|
1.406
(1.961)
|
| Day 15 |
-1.102
(1.690)
|
-0.724
(2.525)
|
-0.607
(2.646)
|
| Title | Change From Baseline in the Inflammatory Biomarker Serum Amyloid A |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some patients did not undertake all assessments. |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| 72 hours |
8.950
(246.317)
|
-45.160
(126.986)
|
-34.510
(58.518)
|
| Day 8 |
-6.363
(117.794)
|
-46.561
(144.630)
|
-35.887
(64.144)
|
| Day 15 |
-50.524
(105.170)
|
-25.328
(144.039)
|
14.370
(146.627)
|
| Title | The Percent of Patients With at Least One Adverse Event |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 55 | 52 |
| Number [Percent] |
40.7
|
38.2
|
55.8
|
| Title | The Percent of Patients With at Least One Serious Adverse Event, Including Death |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 55 | 52 |
| Number [Percent] |
0
|
7.3
|
0
|
| Title | Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some patients did not undertake all assessments. |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 55 | 52 |
| First flare : Baseline |
2.032
(2.493)
|
4.883
(24.378)
|
1.950
(2.755)
|
| First flare : 72 hours |
1.974
(1.793)
|
267.744
(246.086)
|
628.053
(540.488)
|
| First flare : Day 8 |
1.692
(1.343)
|
6.750
(10.439)
|
34.777
(87.812)
|
| First flare : Day 15 |
1.533
(0.226)
|
1.588
(0.443)
|
1.574
(0.356)
|
| First flare : Day 28 |
1.635
(0.615)
|
1.659
(1.057)
|
1.779
(0.895)
|
| First flare : Week 12 |
1.500
(0.000)
|
1.625
(0.478)
|
1.719
(0.681)
|
| Second flare : Baseline |
1.748
(1.024)
|
1.718
(0.732)
|
1.500
(0.00)
|
| Second flare : 72 hours |
1.628
(0.526)
|
254.930
(249.962)
|
719.667
(840.530)
|
| Second flare : Day 8 |
3.141
(6.270)
|
7.048
(20.338)
|
48.785
(114.114)
|
| Second flare : Day 15 |
1.845
(1291)
|
1.595
(0.457)
|
1.500
(0.00)
|
| Second flare : Day 28 |
1.975
(1.714)
|
1.692
(0.882)
|
1.500
(0.00)
|
| Second flare : Week 12 |
2.920
(4.490)
|
1.681
(0.725)
|
1.692
(0.636)
|
| Third flare : Baseline |
2.05
(1.24)
|
1.50
(0.00)
|
1.50
(0.00)
|
| Third flare : 72 hours |
1.85
(0.78)
|
196.67
(192.56)
|
431.63
(298.51)
|
| Third flare : Day 8 |
1.50
(0.00)
|
5.56
(12.97)
|
10.70
(15.42)
|
| Third flare : Day 15 |
1.50
(0.00)
|
1.63
(0.44)
|
1.50
(0.00)
|
| Third flare : Day 28 |
1.85
(0.78)
|
1.50
(0.00)
|
2.47
(2.38)
|
| Third flare : Week 12 |
2.85
(1.91)
|
1.50
(0.00)
|
1.50
(0.00)
|
| Fourth flare : Baseline |
1.50
(0.00)
|
1.50
(0.00)
|
1.50
(0.00)
|
| Fourth flare : 72 hours |
1.50
(0.00)
|
184.40
(198.19)
|
916.62
(1549.55)
|
| Fourth flare : Day 8 |
1.50
(0.00)
|
1.89
(1.02)
|
20.62
(34.10)
|
| Fourth flare : Day 15 |
1.50
(0.00)
|
1.50
(0.00)
|
1.50
(0.00)
|
| Fourth flare : Day 28 |
1.50
(0.00)
|
1.50
(0.00)
|
1.50
(0.00)
|
| Fourth flare : Week 12 |
1.50
(0.00)
|
2.66
(2.60)
|
1.50
(0.00)
|
| Fifth flare : Baseline |
1.50
(0.00)
|
1.50
(0.00)
|
1.50
(0.00)
|
| Fifthe flare : 72 hours |
1.50
(0.00)
|
129.20
(200.26)
|
292.35
(308.56)
|
| Fifthe flare : Day 8 |
1.50
(0.00)
|
1.50
(0.00)
|
6.39
(9.49)
|
| Fifthe flare : Day 15 |
1.50
(0.00)
|
1.50
(0.00)
|
1.50
(0.00)
|
| Fifthe flare : Day 28 |
1.50
(0.00)
|
3.31
(2.55)
|
1.50
(0.00)
|
| Fifth flare : Week 12 |
1.50
(0.00)
|
1.50
(0.00)
|
| Title | Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some patients did not undertake all assessments. |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 55 | 52 |
| First flare : Baseline |
2
3.6%
|
5
8.9%
|
2
3.7%
|
| First flare : Day 8 |
1
1.8%
|
4
7.1%
|
3
5.6%
|
| First flare : Day 15 |
0
0%
|
5
8.9%
|
4
7.4%
|
| First flare : Day 28 |
0
0%
|
4
7.1%
|
2
3.7%
|
| First flare : Week 12 |
0
0%
|
4
7.1%
|
0
0%
|
| Second flare : Baseline |
0
0%
|
0
0%
|
2
3.7%
|
| Second flare : Day 8 |
0
0%
|
1
1.8%
|
2
3.7%
|
| Second flare : Day 15 |
0
0%
|
1
1.8%
|
0
0%
|
| Second flare : Day 28 |
0
0%
|
1
1.8%
|
1
1.9%
|
| Second flare : Week 12 |
0
0%
|
0
0%
|
1
1.9%
|
| Third flare : Baseline |
0
0%
|
0
0%
|
2
3.7%
|
| Third flare : Day 8 |
0
0%
|
1
1.8%
|
4
7.4%
|
| Third flare : Day 15 |
0
0%
|
1
1.8%
|
4
7.4%
|
| Third flare : Day 28 |
0
0%
|
1
1.8%
|
0
0%
|
| Third flare : Week 12 |
0
0%
|
0
0%
|
0
0%
|
| Fourth flare : Baseline |
0
0%
|
0
0%
|
2
3.7%
|
| Fourth flare : Day 8 |
0
0%
|
1
1.8%
|
3
5.6%
|
| Fourth flare : Day 15 |
0
0%
|
1
1.8%
|
4
7.4%
|
| Fourth flare : Day 28 |
0
0%
|
1
1.8%
|
1
1.9%
|
| Fourth flare : Week 12 |
0
0%
|
1
1.8%
|
0
0%
|
| Fifth flare : Baseline |
0
0%
|
0
0%
|
1
1.9%
|
| Fifth flare : Day 8 |
0
0%
|
1
1.8%
|
2
3.7%
|
| Fifth flare : Day 15 |
0
0%
|
2
3.6%
|
2
3.7%
|
| Fifth flare : Day 28 |
0
0%
|
1
1.8%
|
2
3.7%
|
| Fifth flare : Week 12 |
0
0%
|
0
0%
|
0
0%
|
| Title | Proportion of Patients With Neutralizing Antibodies |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some patients did not undertake all assessments. |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 54 | 55 | 52 |
| First flare : Baseline |
0
0%
|
0
0%
|
0
0%
|
| First flare : Day 8 |
0
0%
|
0
0%
|
0
0%
|
| First flare : Day 15 |
0
0%
|
0
0%
|
0
0%
|
| First flare : Day 28 |
0
0%
|
0
0%
|
0
0%
|
| First flare : Week 12 |
0
0%
|
0
0%
|
0
0%
|
| Second flare : Study baseline |
0
0%
|
0
0%
|
0
0%
|
| Second flare : Flare baseline |
0
0%
|
0
0%
|
0
0%
|
| Second flare : Day 8 |
0
0%
|
0
0%
|
0
0%
|
| Second flare : Day 15 |
0
0%
|
0
0%
|
0
0%
|
| Second flare : Day 28 |
0
0%
|
0
0%
|
0
0%
|
| Second flare : Week 12 |
0
0%
|
0
0%
|
0
0%
|
| Third flare : Study baseline |
0
0%
|
0
0%
|
0
0%
|
| Third flare : Flare baseline |
0
0%
|
0
0%
|
0
0%
|
| Third flare : Day 8 |
0
0%
|
0
0%
|
0
0%
|
| Third flare : Day 15 |
0
0%
|
0
0%
|
0
0%
|
| Third flare : Day 28 |
0
0%
|
0
0%
|
0
0%
|
| Third flare : Week 12 |
0
0%
|
0
0%
|
0
0%
|
| Fourth flare : Study baseline |
0
0%
|
0
0%
|
0
0%
|
| Fourth flare : Flare baseline |
0
0%
|
0
0%
|
0
0%
|
| Fourth flare : Day 8 |
0
0%
|
1
1.8%
|
0
0%
|
| Fourth flare : Day 15 |
0
0%
|
0
0%
|
1
1.9%
|
| Fourth flare : Day 28 |
0
0%
|
0
0%
|
0
0%
|
| Fourth flare : Week 12 |
0
0%
|
0
0%
|
0
0%
|
| Fifth flare : Study baseline |
0
0%
|
0
0%
|
0
0%
|
| Fifth flare : Flare baseline |
0
0%
|
0
0%
|
0
0%
|
| Fifth flare : Day 8 |
0
0%
|
0
0%
|
0
0%
|
| Fifth flare : Day 15 |
0
0%
|
0
0%
|
0
0%
|
| Fifth flare : Day 28 |
0
0%
|
0
0%
|
0
0%
|
| Fifth flare : Week 12 |
0
0%
|
0
0%
|
0
0%
|
| Title | Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some patients did not undertake all assessments. |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| Day 8 |
8.0
(9.8)
|
10.5
(10.0)
|
10.4
(8.3)
|
| Day 15 |
11.8
(8.2)
|
12.2
(11.9)
|
9.4
(8.7)
|
| Title | Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| Improvement 4 step |
2
3.6%
|
1
1.8%
|
0
0%
|
| Improvement 3 step |
5
9.1%
|
6
10.7%
|
5
9.3%
|
| Improvement 2 step |
12
21.8%
|
9
16.1%
|
11
20.4%
|
| Improvement 1 step |
5
9.1%
|
18
32.1%
|
12
22.2%
|
| No change |
14
25.5%
|
7
12.5%
|
9
16.7%
|
| Deterioration 1 steps |
3
5.5%
|
3
5.4%
|
2
3.7%
|
| Deterioration 2 steps |
0
0%
|
3
5.4%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
14
25.5%
|
9
16.1%
|
15
27.8%
|
| Improvement 4 step |
2
3.6%
|
1
1.8%
|
0
0%
|
| Improvement 3 step |
7
12.7%
|
7
12.5%
|
2
3.7%
|
| Improvement 2 step |
11
20%
|
10
17.9%
|
15
27.8%
|
| Improvement 1 step |
8
14.5%
|
16
28.6%
|
10
18.5%
|
| No change |
9
16.4%
|
5
8.9%
|
14
25.9%
|
| Deterioration 1 steps |
1
1.8%
|
4
7.1%
|
2
3.7%
|
| Deterioration 2 steps |
0
0%
|
1
1.8%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
17
30.9%
|
12
21.4%
|
11
20.4%
|
| Improvement 4 step |
2
3.6%
|
1
1.8%
|
0
0%
|
| Improvement 3 step |
3
5.5%
|
3
5.4%
|
3
5.6%
|
| Improvement 2 step |
4
7.3%
|
3
5.4%
|
7
13%
|
| Improvement 1 step |
7
12.7%
|
11
19.6%
|
6
11.1%
|
| No change |
23
41.8%
|
27
48.2%
|
22
40.7%
|
| Deterioration 1 steps |
1
1.8%
|
1
1.8%
|
1
1.9%
|
| Deterioration 2 steps |
1
1.8%
|
1
1.8%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
14
25.5%
|
9
16.1%
|
15
27.8%
|
| Improvement 4 step |
2
3.6%
|
1
1.8%
|
0
0%
|
| Improvement 3 step |
2
3.6%
|
3
5.4%
|
1
1.9%
|
| Improvement 2 step |
5
9.1%
|
5
8.9%
|
7
13%
|
| Improvement 1 step |
8
14.5%
|
10
17.9%
|
10
18.5%
|
| No change |
20
36.4%
|
21
37.5%
|
25
46.3%
|
| Deterioration 1 steps |
1
1.8%
|
3
5.4%
|
0
0%
|
| Deterioration 2 steps |
0
0%
|
1
1.8%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
17
30.9%
|
12
21.4%
|
11
20.4%
|
| Improvement 4 step |
3
5.5%
|
0
0%
|
0
0%
|
| Improvement 3 step |
3
5.5%
|
6
10.7%
|
2
3.7%
|
| Improvement 2 step |
15
27.3%
|
11
19.6%
|
13
24.1%
|
| Improvement 1 step |
10
18.2%
|
14
25%
|
9
16.7%
|
| No change |
6
10.9%
|
12
21.4%
|
14
25.9%
|
| Deterioration 1 steps |
4
7.3%
|
2
3.6%
|
1
1.9%
|
| Deterioration 2 steps |
0
0%
|
2
3.6%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
14
25.5%
|
9
16.1%
|
15
27.8%
|
| Improvement 4 step |
2
3.6%
|
1
1.8%
|
0
0%
|
| Improvement 3 step |
8
14.5%
|
7
12.5%
|
0
0%
|
| Improvement 2 step |
10
18.2%
|
11
19.6%
|
13
24.1%
|
| Improvement 1 step |
10
18.2%
|
12
21.4%
|
13
24.1%
|
| No change |
6
10.9%
|
9
16.1%
|
14
25.9%
|
| Deterioration 1 steps |
2
3.6%
|
3
5.4%
|
2
3.7%
|
| Deterioration 2 steps |
0
0%
|
1
1.8%
|
1
1.9%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
17
30.9%
|
12
21.4%
|
11
20.4%
|
| Improvement 4 step |
3
5.5%
|
3
5.4%
|
0
0%
|
| Improvement 3 step |
5
9.1%
|
11
19.6%
|
11
20.4%
|
| Improvement 2 step |
16
29.1%
|
12
21.4%
|
15
27.8%
|
| Improvement 1 step |
12
21.8%
|
15
26.8%
|
9
16.7%
|
| No change |
4
7.3%
|
4
7.1%
|
4
7.4%
|
| Deterioration 1 steps |
0
0%
|
1
1.8%
|
0
0%
|
| Deterioration 2 steps |
1
1.8%
|
1
1.8%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
14
25.5%
|
9
16.1%
|
15
27.8%
|
| Improvement 4 step |
3
5.5%
|
3
5.4%
|
1
1.9%
|
| Improvement 3 step |
9
16.4%
|
11
19.6%
|
10
18.5%
|
| Improvement 2 step |
17
30.9%
|
13
23.2%
|
14
25.9%
|
| Improvement 1 step |
5
9.1%
|
11
19.6%
|
10
18.5%
|
| No change |
3
5.5%
|
2
3.6%
|
8
14.8%
|
| Deterioration 1 steps |
1
1.8%
|
3
5.4%
|
0
0%
|
| Deterioration 2 steps |
0
0%
|
1
1.8%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
17
30.9%
|
12
21.4%
|
11
20.4%
|
| Improvement 4 step |
1
1.8%
|
0
0%
|
0
0%
|
| Improvement 3 step |
2
3.6%
|
2
3.6%
|
0
0%
|
| Improvement 2 step |
3
5.5%
|
0
0%
|
3
5.6%
|
| Improvement 1 step |
5
9.1%
|
9
16.1%
|
9
16.7%
|
| No change |
26
47.3%
|
33
58.9%
|
25
46.3%
|
| Deterioration 1 steps |
4
7.3%
|
3
5.4%
|
2
3.7%
|
| Deterioration 2 steps |
0
0%
|
0
0%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
14
25.5%
|
9
16.1%
|
15
27.8%
|
| Improvement 4 step |
1
1.8%
|
0
0%
|
0
0%
|
| Improvement 3 step |
1
1.8%
|
2
3.6%
|
0
0%
|
| Improvement 2 step |
4
7.3%
|
1
1.8%
|
3
5.6%
|
| Improvement 1 step |
7
12.7%
|
6
10.7%
|
10
18.5%
|
| No change |
23
41.8%
|
33
58.9%
|
26
48.1%
|
| Deterioration 1 steps |
0
0%
|
2
3.6%
|
4
7.4%
|
| Deterioration 2 steps |
2
3.6%
|
0
0%
|
0
0%
|
| Deterioration 3 steps |
0
0%
|
0
0%
|
0
0%
|
| Detorioration 4 steps |
0
0%
|
0
0%
|
0
0%
|
| Missing |
17
30.9%
|
12
21.4%
|
11
20.4%
|
| Title | Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some patients did not undertake all assessments. |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| First flare : Day 8 |
36.1
(34.3)
|
32.6
(29.1)
|
20.5
(25.0)
|
| First flare : Day 15 |
23.3
(24.8)
|
12.6
(20.7)
|
21.6
(22.3)
|
| Second flare : Day 8 |
42.9
(27.5)
|
24.0
(26.3)
|
24.0
(27.2)
|
| Second flare : Day 15 |
16.0
(25.1)
|
20.0
(17.6)
|
13.8
(16.9)
|
| Third flare : Day 8 |
10.0
|
5.0
(7.1)
|
10.0
(10.0)
|
| Third flare : Day 15 |
10.0
|
20.0
(24.5)
|
23.3
(32.1)
|
| Fourth flare : Day 8 |
30.0
|
20.0
(34.6)
|
|
| Fourth flare : Day 15 |
5.0
(7.1)
|
||
| Fifth flare : Day 8 |
60.0
|
26.7
(25.2)
|
|
| Fifth flare : Day 15 |
20.0
|
40.0
|
13.3
(11.5)
|
| Title | Health Care Resource Utilization Due to a Gouty Arthritis Flare |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some patients did not undertake all assessments. |
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 55 | 56 | 54 |
| Hospitalization : First flare : Day 1-7 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : First flare : Day 8-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : First flare : Day 1-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Second flare : Day 1-7 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Second flare : Day 8-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Second flare : Day 1-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Third flare : Day 1-7 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Third flare : Day 8-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Third flare : Day 1-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Fourth flare : Day 1-7 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Fourth flare : Day 8-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Fourth flare : Day 1-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Fifth flare : Day 1-7 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Fifth flare : Day 8-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Hospitalization : Fifth flare : Day 1-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visits:First flare: Day 1-7 |
0.1
(0.5)
|
0
(0)
|
0.1
(0.6)
|
| Unscheduled outpatient visits:First flare:Day 8-15 |
0.3
(1.4)
|
0.1
(0.6)
|
0
(0)
|
| Unscheduled outpatient visits:First flare:Day 1-15 |
0.4
(1.4)
|
0.1
(0.6)
|
0.1
(0.6)
|
| Unscheduled outpatient visits:Second flare:Day 1-7 |
0.2
(0.8)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visit:Second flare:Day 8-15 |
0.2
(0.6)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visit:Second flare:Day 1-15 |
0.5
(1.5)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visits:Third flare:Day 1-7 |
0.4
(0.9)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visits:Third flare:Day 8-15 |
0.4
(0.9)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visits:Third flare:Day 1-15 |
0.8
(1.8)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visitstFourth flare:Day 1-7 |
0
(0)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visitsFourth flare:Day 8-15 |
0
(0)
|
0
(0)
|
0
(0)
|
| Unscheduled outpatient visitsFourth flare:Day 1-15 |
0
(0)
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0
(0)
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0
(0)
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| Unscheduled outpatient visit:Fifth flare : Day 1-7 |
0
(0)
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0
(0)
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0
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| Unscheduled outpatient visitFifth flare : Day 8-15 |
0
(0)
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0
(0)
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0
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| Unscheduled outpatient visit Fifth flare:Day 1-15 |
0
(0)
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0
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0
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Adverse Events
| Time Frame | The period for recording all adverse events, including SAEs begins upon receiving the first dose of Investigational medicinal product (IMP) and ends with a follow-up telephone call 5 weeks after the first dose of IMP. SAEs will also be collected from signing of the Informed consent form (ICF) until the Week 12 visit | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg | |||
| Arm/Group Description | 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 | 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 | 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 | |||
All Cause Mortality |
||||||
| Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/54 (0%) | 0/55 (0%) | 0/52 (0%) | |||
Serious Adverse Events |
||||||
| Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/54 (0%) | 4/55 (7.3%) | 1/52 (1.9%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/54 (0%) | 1/55 (1.8%) | 0/52 (0%) | |||
| Cardiac disorders | ||||||
| Coronary artery disease | 0/54 (0%) | 1/55 (1.8%) | 1/52 (1.9%) | |||
| Congenital, familial and genetic disorders | ||||||
| Sickel cell anaemia | 0/54 (0%) | 1/55 (1.8%) | 0/52 (0%) | |||
| Gastrointestinal disorders | ||||||
| Gastric ulcer | 0/54 (0%) | 1/55 (1.8%) | 0/52 (0%) | |||
| Nervous system disorders | ||||||
| Seizure | 0/54 (0%) | 1/55 (1.8%) | 0/52 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Triamcinolone 40 mg | Anakinra 100 mg | Anakinra 200 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/54 (40.7%) | 19/55 (34.5%) | 29/52 (55.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Neutropenia | 0/54 (0%) | 1/55 (1.8%) | 1 | 3/52 (5.8%) | 5 | |
| Neutrophilia | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Thrombocytopenia | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Leukocytosis | 0/54 (0%) | 0/55 (0%) | 0/52 (0%) | |||
| Congenital, familial and genetic disorders | ||||||
| Type IIa hyperlipidaemia | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Eye disorders | ||||||
| Eyelid oedema | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Vitreous floaters | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Gastrointestinal disorders | ||||||
| Nausea | 1/54 (1.9%) | 1 | 2/55 (3.6%) | 2 | 1/52 (1.9%) | 1 |
| Vomiting | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 1/52 (1.9%) | 1 |
| Flatulence | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Gastritis | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Gastrointestinal haemorrhage | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Haemorrhoids | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Hyperchlorhydria | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Peritoneal haemorrhage | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Small intestinal perforation | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Umbilical hernia | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Constipation | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Diarrhoea | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Gastrooesophageal reflux disease | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| General disorders | ||||||
| Oedema peripheral | 0/54 (0%) | 1/55 (1.8%) | 2 | 2/52 (3.8%) | 3 | |
| Injection site erythema | 0/54 (0%) | 1/55 (1.8%) | 3 | 1/52 (1.9%) | 1 | |
| Injection site hypersensitivity | 0/54 (0%) | 0/55 (0%) | 2/52 (3.8%) | 3 | ||
| Fatigue | 0/54 (0%) | 1/55 (1.8%) | 1 | 1/52 (1.9%) | 1 | |
| Injection site reaction | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Pyrexia | 2/54 (3.7%) | 2 | 0/55 (0%) | 2 | 0/52 (0%) | 2 |
| Injection site pruritus | 0/54 (0%) | 1/55 (1.8%) | 3 | 0/52 (0%) | 3 | |
| Injection site swelling | 0/54 (0%) | 1/55 (1.8%) | 3 | 0/52 (0%) | 3 | |
| Injection site haematoma | 0/54 (0%) | 1/55 (1.8%) | 2 | 0/52 (0%) | 2 | |
| Injection site induration | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 2 | ||
| Gait disturbance | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Injection site pain | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Impaired healing | 0/54 (0%) | 0/55 (0%) | 0/52 (0%) | |||
| Infections and infestations | ||||||
| Influenza | 0/54 (0%) | 3/55 (5.5%) | 3 | 5/52 (9.6%) | 9 | |
| Nasopharyngitis | 0/54 (0%) | 1/55 (1.8%) | 1 | 1/52 (1.9%) | 1 | |
| Upper respiratory tract infection | 0/54 (0%) | 1/55 (1.8%) | 1 | 1/52 (1.9%) | 1 | |
| Bronchitis | 0/54 (0%) | 1/55 (1.8%) | 1 | 1/52 (1.9%) | 1 | |
| Escherichia infection | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Haemophilus infection | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Pharyngitis streptococcal | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Pyelonephritis | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Tooth infection | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Injury, poisoning and procedural complications | ||||||
| Ligament sprain | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 2/52 (3.8%) | 2 |
| Contusion | 0/54 (0%) | 0/55 (0%) | 2/52 (3.8%) | 3 | ||
| Limb injury | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 1/52 (1.9%) | 1 |
| Acetabulum fracture | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Cardiac contusion | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Rib fracture | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Road traffic accident | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Spinal fracture | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Sternal fracture | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Thoracic vertebral fracture | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Wound necrosis | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Investigations | ||||||
| Blood pressure increased | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 1/52 (1.9%) | 2 |
| Glomerular filtration rate decreased | 1/54 (1.9%) | 1 | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 |
| Troponin T increased | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 1/52 (1.9%) | 1 |
| Albumin urine present | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Blood creatinine increased | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| High density lipoprotein decreased | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| White blood cell count increased | 0/54 (0%) | 0/55 (0%) | 0/52 (0%) | |||
| Blood triglycerides increased | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 5/52 (9.6%) | 14 |
| Metabolism and nutrition disorders | ||||||
| Hypertriglyceridaemia | 0/54 (0%) | 3/55 (5.5%) | 3 | 2/52 (3.8%) | 2 | |
| Hypoglycaemia | 0/54 (0%) | 0/55 (0%) | 0 | 1/52 (1.9%) | 3 | |
| Hyperuricaemia | 0/54 (0%) | 0/55 (0%) | 0 | 1/52 (1.9%) | 1 | |
| Increased appetite | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 0 | |
| Malnutrition | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Type 2 diabetes mellitus | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/54 (1.9%) | 1 | 2/55 (3.6%) | 2 | 2/52 (3.8%) | 2 |
| Intervertebral disc protrusion | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Musculoskeletal chest pain | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Musculoskeletal pain | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Pain in extremity | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Plantar fasciitis | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Back pain | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Muscle spasms | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Synovitis | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Nervous system disorders | ||||||
| Headache | 2/54 (3.7%) | 2 | 0/55 (0%) | 2 | 2/52 (3.8%) | 2 |
| Loss of consciousness | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Nystagmus | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Seizure | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Somnolence | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Psychiatric disorders | ||||||
| Stress | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 2 | ||
| Anger | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Delirium | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Mood swings | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Renal and urinary disorders | ||||||
| Microalbuminuria | 0/54 (0%) | 0/55 (0%) | 2/52 (3.8%) | 2 | ||
| Renal failure | 0/54 (0%) | 1/55 (1.8%) | 3 | 0/52 (0%) | 3 | |
| Acute kidney injury | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Renal cyst | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Dysuria | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Nephrolithiasis | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Renal impairment | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea exertional | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Haemothorax | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Pneumothorax | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Respiratory failure | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Wheezing | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Skin and subcutaneous tissue disorders | ||||||
| Rash | 0/54 (0%) | 1/55 (1.8%) | 1 | 1/52 (1.9%) | 1 | |
| Decubitus ulcer | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 6 | ||
| Hyperhidrosis | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Rash macular | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Skin ulcer | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Vascular disorders | ||||||
| Hypertension | 0/54 (0%) | 1/55 (1.8%) | 1 | 0/52 (0%) | 1 | |
| Orthostatic hypotension | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Shock haemorrhagic | 0/54 (0%) | 0/55 (0%) | 1/52 (1.9%) | 1 | ||
| Aortic arteriosclerosis | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
| Flushing | 1/54 (1.9%) | 1 | 0/55 (0%) | 1 | 0/52 (0%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kineret Clinical Program Leader |
|---|---|
| Organization | Swedish Orphan Biovitrum |
| Phone | +46(8)6972000 |
| info@sobi.com |
Responsible Party:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT03002974
Other Study ID Numbers:
- Sobi.ANAKIN-401
First Posted:
Dec 26, 2016
Last Update Posted:
Jul 15, 2020
Last Verified:
Jun 1, 2020