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

July 1, 2020 updated by: Swedish Orphan Biovitrum

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Gulf Shores, Alabama, United States, 36542
        • Fundamental Research, LLC
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Delta Waves Sleep Disorder and Research Center
    • Florida
      • Brandon, Florida, United States, 33511
        • Pulmonary Associates of Brandon
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Jupiter, Florida, United States, 33458
        • Health Awareness
      • Miami, Florida, United States, 33143
        • Well Pharma Medical Research
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida
      • Tampa, Florida, United States, 33634
        • Meridien Research, Inc
    • Georgia
      • Conyers, Georgia, United States, 30013
        • Kaushik Amin MD
      • Dunwoody, Georgia, United States, 30338
        • Alta Pharmaceutical Research Center
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • Lemah Creek Clinical Research
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5422
        • University of Michigan
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Shelby, North Carolina, United States, 28150
        • Boiling Springs Medical Research, Inc.
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
      • Cincinnati, Ohio, United States, 45224
        • Hightop Medical Research Center
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Clinical Research Solutions - Franklin
      • Smyrna, Tennessee, United States, 37167
        • Clinical Research Solutions
    • Texas
      • Dallas, Texas, United States, 75234
        • Renaissance Clinical Research and Hypertension Clinic of Texas, PLLC
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions, Inc.
      • Pasadena, Texas, United States, 77505
        • Accurate Clinical Management
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
    • Utah
      • Bountiful, Utah, United States, 84010
        • Wade Family Medicine
      • Clinton, Utah, United States, 84015
        • Ericksen Research & Development
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research - West Jordan
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Commonwealth Clinical Research Specialists, Inc.
      • Virginia Beach, Virginia, United States, 23462
        • Corporation Lane Internal Medicine and Research Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Mileground Physicians, PLLC
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Clinical Investigations Specialists, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Kineret
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:
  • Placebo Kineret
Drug: Placebo to Triamcinolone Acetonide 40 mg
1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
Other Names:
  • Placebo Kenalog
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:
  • Kineret
Drug: Placebo to Triamcinolone Acetonide 40 mg
1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
Other Names:
  • Placebo Kenalog
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: 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:
  • Placebo Kineret
Drug: Triamcinolone Acetonide 40 mg
1 mL intramuscular injection of a 40 mg/mL injectable suspension
Other Names:
  • Triamcinolone
  • Kenalog

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS
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.
At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
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
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.
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
Onset of effect defined as 20% change from baseline pain intensity in the index joint on a visual analogue scale (VAS)
From baseline (predose) up to Day15 of the first flare treated in the study
Median Time to Response
Time Frame: 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)
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
Resolution of pain defined as <10 mm on VAS, a continuous 0 to 100 mm visual analogue scale, ranging from no pain (0) to unbearable pain (100), in the index joint
From baseline (predose) up to Day15 of the first flare
Median Time to First Intake of Rescue Medication From First Investigational Drug Administration
Time Frame: 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
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
5-point Likert scale (0- to 4-point scale: "none", "mild", "moderate", "severe, "extreme") where higher score mean worse outcome
At 72 hours, Day 8 and Day 15 for the first flare treated in the study
Physician's Assessment of Clinical Signs in Index Joint: Tenderness
Time Frame: 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
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
4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins)
at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Physician's Assessment of Clinical Signs in Index Joint: Erythema
Time Frame: 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
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
5-point Likert scale (0- to 4-point scale: 0=excellent, 1=very good, 2=good, 3=fair, 4=poor response to treatment) where lower rate indicates better response to treatment
at 72 hours, Day 8 and Day 15 for the first flare treated in the study
Change From Baseline in the Inflammatory Biomarker C Reactive Protein
Time Frame: 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
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
This endpoint represents the change from baseline, mg/L, of the inflammatory biomarker Serum amyloid A
baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study
The Percent of Patients With at Least One Adverse Event
Time Frame: 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.
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
Serious Adverse Events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence.
Through study completion, at 12 weeks after last flare treated during the extension period
Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
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
This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra
Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period
Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
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
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated treated during the extension period
Proportion of Patients With Neutralizing Antibodies
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
Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies
Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period
Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score
Time Frame: 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.
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
Exploratory objective. The EQ-5D-5L, a self-report questionnaire, is a descriptive system of Health related quality of life (HRQL) states consisting of 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression), each of which can have 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
at baseline, Day 8 and Day 15 for the first flare treated in the study
Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
Time Frame: 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.
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
Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits
Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swedish Orphan Biovitrum

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sven Ohlman, MD, PhD, Swedish Orphan Biovitrum AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sobi.ANAKIN-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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