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A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis (anaGO)

Primary Purpose

Acute Gouty Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anakinra 100 mg
Triamcinolone Acetonide 40 mg
Placebo to Anakinra 100 mg
Placebo to Triamcinolone Acetonide 40 mg
Sponsored by
Swedish Orphan Biovitrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Gout, Interleukin 1 receptor antagonist, IL-1 receptor antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Fundamental Research, LLC
  • Coastal Clinical Research, Inc
  • Advanced Research Center
  • Delta Waves Sleep Disorder and Research Center
  • Pulmonary Associates of Brandon
  • Meridien Research
  • Health Awareness
  • Well Pharma Medical Research
  • Clinical Neuroscience Solutions
  • Clinical Research Trials of Florida
  • Meridien Research, Inc
  • Kaushik Amin MD
  • Alta Pharmaceutical Research Center
  • Lemah Creek Clinical Research
  • The Research Group of Lexington
  • Clinical Trials Management
  • University of Michigan
  • Albuquerque Clinical Trials
  • Duke University Medical Center
  • Boiling Springs Medical Research, Inc.
  • PMG Research of Winston-Salem
  • Hightop Medical Research Center
  • New Horizons Clinical Research
  • Clinical Research Solutions - Franklin
  • Clinical Research Solutions
  • Renaissance Clinical Research and Hypertension Clinic of Texas, PLLC
  • Pioneer Research Solutions, Inc.
  • Accurate Clinical Management
  • Sun Research Institute
  • Wade Family Medicine
  • Ericksen Research & Development
  • Advanced Clinical Research - West Jordan
  • Commonwealth Clinical Research Specialists, Inc.
  • Corporation Lane Internal Medicine and Research Center
  • Mileground Physicians, PLLC
  • Clinical Investigations Specialists, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Anakinra 100 mg

Anakinra 200 mg

Triamcinolone 40 mg

Arm Description

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

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

2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg

Outcomes

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
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
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
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
Response defined as 50% change from baseline pain intensity on a visual analogue scale (VAS)
Median Time to Resolution of Pain
Resolution of pain defined as <10 mm on VAS, a continuous 0 to 100 mm visual analogue scale, ranging from no pain (0) to unbearable pain (100), in the index joint
Median Time to First Intake of Rescue Medication From First Investigational Drug Administration
Time to first intake of rescue medication for acute gout, measured in hours from first investigational drug administration
Physician's Assessment of Global Response to Treatment
5-point Likert scale (0- to 4-point scale: "none", "mild", "moderate", "severe, "extreme") where higher score mean worse outcome
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
4-point Likert scale (0=no pain, 1= mild/patient states there is pain when touched, 2= moderate/patient states there is pain and Winces, 3=severe/patient states there is pain, winces and withdraws
Physician's Assessment of Clinical Signs in Index Joint: Swelling
4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins)
Physician's Assessment of Clinical Signs in Index Joint: Erythema
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)
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
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
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
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
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
This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Proportion of Patients With Neutralizing Antibodies
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
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)
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
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
Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits

Full Information

First Posted
December 13, 2016
Last Updated
July 1, 2020
Sponsor
Swedish Orphan Biovitrum
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1. Study Identification

Unique Protocol Identification Number
NCT03002974
Brief Title
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis
Acronym
anaGO
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gouty Arthritis
Keywords
Gout, Interleukin 1 receptor antagonist, IL-1 receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anakinra 100 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Anakinra 200 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Triamcinolone 40 mg
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Anakinra 100 mg
Other Intervention Name(s)
Kineret
Intervention Description
100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 40 mg
Other Intervention Name(s)
Kenalog, Triamcinolone
Intervention Description
1 mL intramuscular injection of a 40 mg/mL injectable suspension
Intervention Type
Drug
Intervention Name(s)
Placebo to Anakinra 100 mg
Other Intervention Name(s)
Placebo Kineret
Intervention Description
sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Intervention Type
Drug
Intervention Name(s)
Placebo to Triamcinolone Acetonide 40 mg
Other Intervention Name(s)
Placebo Kenalog
Intervention Description
1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Ohlman, MD, PhD
Organizational Affiliation
Swedish Orphan Biovitrum AB
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Fundamental Research, LLC
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
Coastal Clinical Research, Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Advanced Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Delta Waves Sleep Disorder and Research Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Pulmonary Associates of Brandon
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Health Awareness
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Well Pharma Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Research Trials of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Meridien Research, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Kaushik Amin MD
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30013
Country
United States
Facility Name
Alta Pharmaceutical Research Center
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Lemah Creek Clinical Research
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
The Research Group of Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5422
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Boiling Springs Medical Research, Inc.
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Clinical Research Solutions - Franklin
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Clinical Research Solutions
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Renaissance Clinical Research and Hypertension Clinic of Texas, PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Accurate Clinical Management
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Wade Family Medicine
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Ericksen Research & Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Advanced Clinical Research - West Jordan
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Commonwealth Clinical Research Specialists, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Corporation Lane Internal Medicine and Research Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Mileground Physicians, PLLC
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Clinical Investigations Specialists, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33605029
Citation
Saag KG, Khanna PP, Keenan RT, Ohlman S, Osterling Koskinen L, Sparve E, Akerblad AC, Wiken M, So A, Pillinger MH, Terkeltaub R. A Randomized, Phase II Study Evaluating the Efficacy and Safety of Anakinra in the Treatment of Gout Flares. Arthritis Rheumatol. 2021 Aug;73(8):1533-1542. doi: 10.1002/art.41699. Epub 2021 Jul 7.
Results Reference
derived

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis

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