Acute Gouty ArthritisPhase 2anaGONCT03002974
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis
A Phase 2 study testing Anakinra 100 mg and Triamcinolone Acetonide 40 mg in people with Acute Gouty Arthritis, run by Swedish Orphan Biovitrum at 37 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gouty Arthritis
- What is being tested?
- Anakinra 100 mg and Triamcinolone Acetonide 40 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 37 sitesUnited States
- Study dates
- Dec 2016to Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
- Current flare of gouty arthritis characterized by pain intensity
- Currently tender and swollen joint
- Women of childbearing potential willing to use adequate contraception
Who cannot join
- 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.
Show all 23Show fewer
- 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
- 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
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Advanced Research Center
Anaheim, California, 92805
University of Michigan
Ann Arbor, Michigan, 48109-5422
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Wade Family Medicine
Bountiful, Utah, 84010
Pulmonary Associates of Brandon
Brandon, Florida, 33511
Meridien Research
Brooksville, Florida, 34601
Hightop Medical Research Center
Cincinnati, Ohio, 45224
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Ericksen Research & Development
Clinton, Utah, 84015
Delta Waves Sleep Disorder and Research Center
Colorado Springs, Colorado, 80918
Kaushik Amin MD
Conyers, Georgia, 30013
Renaissance Clinical Research and Hypertension Clinic of Texas, PLLC
Dallas, Texas, 75234
Alta Pharmaceutical Research Center
Dunwoody, Georgia, 30338
Duke University Medical Center
Durham, North Carolina, 27710
Clinical Research Solutions - Franklin
Franklin, Tennessee, 37067
Fundamental Research, LLC
Gulf Shores, Alabama, 36542
Pioneer Research Solutions, Inc.
Houston, Texas, 77099
Health Awareness
Jupiter, Florida, 33458
Clinical Investigations Specialists, Inc.
Kenosha, Wisconsin, 53142
The Research Group of Lexington
Lexington, Kentucky, 40503
Lemah Creek Clinical Research
Melrose Park, Illinois, 60160
Clinical Trials Management
Metairie, Louisiana, 70006
Well Pharma Medical Research
Miami, Florida, 33143
Coastal Clinical Research, Inc
Mobile, Alabama, 36608
Mileground Physicians, PLLC
Morgantown, West Virginia, 26505
Clinical Neuroscience Solutions
Orlando, Florida, 32801
Accurate Clinical Management
Pasadena, Texas, 77505
Commonwealth Clinical Research Specialists, Inc.
Richmond, Virginia, 23235
Sun Research Institute
San Antonio, Texas, 78215
Boiling Springs Medical Research, Inc.
Shelby, North Carolina, 28150
Clinical Research Solutions
Smyrna, Tennessee, 37167
Clinical Research Trials of Florida
Tampa, Florida, 33607
Meridien Research, Inc
Tampa, Florida, 33634
Corporation Lane Internal Medicine and Research Center
Virginia Beach, Virginia, 23462
Advanced Clinical Research - West Jordan
West Jordan, Utah, 84088
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Acute Gouty Arthritis
- Being tested
- Anakinra 100 mg, Triamcinolone Acetonide 40 mg, Placebo to Anakinra 100 mg, Placebo to Triamcinolone Acetonide 40 mg
- Keywords
- Gout, Interleukin 1 receptor antagonist, IL-1 receptor antagonist
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra 100 mgDrug
Also called Kineret
100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
Triamcinolone Acetonide 40 mgDrug
Also called Kenalog, Triamcinolone
1 mL intramuscular injection of a 40 mg/mL injectable suspension
Placebo to Anakinra 100 mgDrug
Also called Placebo Kineret
sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
Placebo to Triamcinolone Acetonide 40 mgDrug
Also called Placebo Kenalog
1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
| Study group | Role | What they receive |
|---|---|---|
| Anakinra 100 mg | Experimental | 1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Receives: Drug: Anakinra 100 mg; Drug: Placebo to Anakinra 100 mg; Drug: Placebo to Triamcinolone Acetonide 40 mg |
| Anakinra 200 mg | Experimental | 2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg Receives: Drug: Anakinra 100 mg; Drug: Placebo to Triamcinolone Acetonide 40 mg |
| Triamcinolone 40 mg | Active comparator | 2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg Receives: Drug: Triamcinolone Acetonide 40 mg; Drug: Placebo to Anakinra 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study
Secondary outcomes (21)
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.
Measured: At baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8 for the first gout flare treated in the study
Median Time to Onset of Effect
Onset of effect defined as 20% change from baseline pain intensity in the index joint on a visual analogue scale (VAS)
Measured: From baseline (predose) up to Day15 of the first flare treated in the study
Median Time to Response
Response defined as 50% change from baseline pain intensity on a visual analogue scale (VAS)
Measured: From baseline (predose) up to Day15 of the first flare treated in the study
Median Time to Resolution of Pain
Resolution of pain defined as <10 mm on VAS, a continuous 0 to 100 mm visual analogue scale, ranging from no pain (0) to unbearable pain (100), in the index joint
Measured: From baseline (predose) up to Day15 of the first flare
Median Time to First Intake of Rescue Medication From First Investigational Drug Administration
Time to first intake of rescue medication for acute gout, measured in hours from first investigational drug administration
Measured: From Day 1 to Day 15 for the first flare treated
Physician's Assessment of Global Response to Treatment
5-point Likert scale (0- to 4-point scale: "none", "mild", "moderate", "severe, "extreme") where higher score mean worse outcome
Measured: At 72 hours, Day 8 and Day 15 for the first flare treated in the study
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
4-point Likert scale (0=no pain, 1= mild/patient states there is pain when touched, 2= moderate/patient states there is pain and Winces, 3=severe/patient states there is pain, winces and withdraws
Measured: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Physician's Assessment of Clinical Signs in Index Joint: Swelling
4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins)
Measured: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Physicians assessment of clinical signs with 2 outcomes: Absent=no erythema, present=erythema
Measured: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
5-point Likert scale (0- to 4-point scale: 0=excellent, 1=very good, 2=good, 3=fair, 4=poor response to treatment) where lower rate indicates better response to treatment
Measured: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Change From Baseline in the Inflammatory Biomarker C Reactive Protein
This endpoint represents the change from baseline, mg/dL, of the inflammatory biomarker C reactive protein
Measured: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Change From Baseline in the Inflammatory Biomarker Serum Amyloid A
This endpoint represents the change from baseline, mg/L, of the inflammatory biomarker Serum amyloid A
Measured: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study
The Percent of Patients With at Least One Adverse Event
All adverse events to be recorded Day 1 - Day 28 for each flare. Serious adverse events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence.
Measured: Through study completion, at 12 weeks after last flare treated during the extension period
The Percent of Patients With at Least One Serious Adverse Event, Including Death
Serious Adverse Events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence.
Measured: Through study completion, at 12 weeks after last flare treated during the extension period
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra
Measured: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Measured: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated treated during the extension period
Proportion of Patients With Neutralizing Antibodies
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Measured: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period
Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score
SF-36® measures the impact of disease on overall quality of life. It consists of 8 individual domains. Score range from 0 to 100, where 0 represents the worst possible health and 100 is perfect health.
Measured: at baseline, Day 8 and Day 15 for the first flare treated in the study
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Exploratory objective. The EQ-5D-5L, a self-report questionnaire, is a descriptive system of Health related quality of life (HRQL) states consisting of 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression), each of which can have 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
Measured: at baseline, Day 8 and Day 15 for the first flare treated in the study
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
The WPAI yeilds four types of scores of which Work productivity loss is one.
SHP is derived from WPAI as follows:
The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows:
Questions:
Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities
Scores:
Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working).
Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10.
Measured: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits
Measured: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Gouty ArthritisStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sven Ohlman, MD, PhD, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002974
- Sponsor's protocol ID
- Sobi.ANAKIN-401
- Acronym
- anaGO
- Status last verified
- Jun 2020
- First submitted
- 13 Dec 2016
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33605029
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03002974
- Acronym / sponsor ID
- anaGO / Sobi.ANAKIN-401
- Conditions
- Acute Gouty Arthritis
- Keywords
- Gout, Interleukin 1 receptor antagonist, IL-1 receptor antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Posted 15 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anakinra 100 mg | Experimental | Drug: Anakinra 100 mg, Drug: Placebo to Anakinra 100 mg, Drug: Placebo to Triamcinolone Acetonide 40 mg1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg |
| Anakinra 200 mg | Experimental | Drug: Anakinra 100 mg, Drug: Placebo to Triamcinolone Acetonide 40 mg2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg |
| Triamcinolone 40 mg | Active comparator | Drug: Triamcinolone Acetonide 40 mg, Drug: Placebo to Anakinra 100 mg2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anakinra 100 mgAlso: Kineret100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection | Drug | Anakinra 100 mg, Anakinra 200 mg |
| Triamcinolone Acetonide 40 mgAlso: Kenalog, Triamcinolone1 mL intramuscular injection of a 40 mg/mL injectable suspension | Drug | Triamcinolone 40 mg |
| Placebo to Anakinra 100 mgAlso: Placebo Kineretsterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe | Drug | Anakinra 100 mg, Triamcinolone 40 mg |
| Placebo to Triamcinolone Acetonide 40 mgAlso: Placebo Kenalog1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension | Drug | Anakinra 100 mg, Anakinra 200 mg |
Primary outcome
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
Time frame: 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.
21 secondary outcomes
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
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
Median Time to Onset of Effect
Time frame: From baseline (predose) up to Day15 of the first flare treated in the study
Median Time to Response
Time frame: From baseline (predose) up to Day15 of the first flare treated in the study
Median Time to Resolution of Pain
Time frame: From baseline (predose) up to Day15 of the first flare
Median Time to First Intake of Rescue Medication From First Investigational Drug Administration
Time frame: From Day 1 to Day 15 for the first flare treated
Physician's Assessment of Global Response to Treatment
Time frame: At 72 hours, Day 8 and Day 15 for the first flare treated in the study
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Time frame: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Physician's Assessment of Clinical Signs in Index Joint: Swelling
Time frame: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Time frame: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
Time frame: at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Change From Baseline in the Inflammatory Biomarker C Reactive Protein
Time frame: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Change From Baseline in the Inflammatory Biomarker Serum Amyloid A
Time frame: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study
The Percent of Patients With at Least One Adverse Event
Time frame: Through study completion, at 12 weeks after last flare treated during the extension period
The Percent of Patients With at Least One Serious Adverse Event, Including Death
Time frame: Through study completion, at 12 weeks after last flare treated during the extension period
Serum Concentration 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
Proportion of Patients With Anti-drug Antibodies (ADA) Against 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 treated during the extension period
Proportion of Patients With 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
Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score
Time frame: at baseline, Day 8 and Day 15 for the first flare treated in the study
Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: at baseline, Day 8 and Day 15 for the first flare treated in the study
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Time frame: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period
Health Care Resource Utilization Due to a Gouty Arthritis Flare
Time frame: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33605029Saag 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Ohlman, MD, PhD study director
Swedish Orphan Biovitrum
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra 100 mg and Triamcinolone Acetonide 40 mg in people with Acute Gouty Arthritis, run by Swedish Orphan Biovitrum at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.