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Trial registered on ANZCTR
Registration number
ACTRN12618001372279
Ethics application status
Approved
Date submitted
14/12/2017
Date registered
15/08/2018
Date last updated
24/03/2024
Date data sharing statement initially provided
26/07/2019
Date results information initially provided
26/07/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Gout in Norway (NOR-Gout)
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Scientific title
Gout in Norway (NOR-Gout) - Treating patients with gout to target serum urate
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Secondary ID [1]
293609
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None
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Universal Trial Number (UTN)
U1111-1206-6335
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Trial acronym
NOR-Gout
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gout
305872
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Condition category
Condition code
Musculoskeletal
305070
305070
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0
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Other muscular and skeletal disorders
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Metabolic and Endocrine
305816
305816
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0
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients are treated in the rheumatology outpatient department as clinically required. The treatment objective is to reduce serum urate to a treatment target below 360 micromol/L, and 300 micromol/L in case of tophi. The treatment approach is in line with the EULAR treatment recommendations for gout.
The first drug of choice is allopurinol 100 mg tablets once daylig. The dose will be increased monthly by 100 mg until maximum 900 mg daily is reached or the treatment target is met. In case insufficient effect (i.e. not reaching the treatment target) or adverse events, other approved drugs can be used such as probenecid 500 mg tablets (maximum 1000 mg daily) to increase excretion of uric acid or febuxostat tablets (40 mg to maximum 120 mg daily) as an alternative xanthinoxidase inhibitor. If patients already use urate lowering therapy when included into the study, medication will be increased if necessary to reach the treatment target. All patients who start urate lowering therapy during the study period, will be given flare prophylaxis with anti-inflammatory medication (an NSAID or colchicine orally) for 6 months at the discretion of the treating physician.
Adherence to treatment and adverse events are monitored during the frequent visits by physician or nurse (initially every month), inquiring if the patient has taken the prescribed drugs and has experienced adverse events. Serum urate, as a measure of adherence is also checked frequently and initially every month.
If serum urate at the baseline visit is only slightly increased (360-420µmol/l), diet and life-style advice during the first month can be given alone, to see if these measure are sufficient to reduce serum urate to target until the next study visit. Study visits are initially monthly and monitor adherence to therapy, laboratory tests for serum urate, liver and kidney function as well as adverse events, When the treatment target of 360µmol/l is reached, existing medication is maintained at the present dose and fixed visits are schedules at 3, 6, 12 and 24 months.
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Intervention code [1]
299865
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Lifestyle
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Intervention code [2]
299866
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
304244
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Percentage of patients reaching the treatment target for serum urate of <360 micromol/l (300 micromol/l if tophi).
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Assessment method [1]
304244
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Timepoint [1]
304244
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Primary outcome: Month 12
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Primary outcome [2]
304245
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Percentage of patients with no self-reported gout flares
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Assessment method [2]
304245
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Timepoint [2]
304245
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During months 9-12. Self-reported and assessed over the three-month period at month 12.
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Secondary outcome [1]
341346
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Cardiovascular assessment: Transthoracic echocardiography of the heart and B-mode ultrasonography examination of the carotid arteries bilaterally including plaque echolucency.
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Assessment method [1]
341346
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Timepoint [1]
341346
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Baseline
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Secondary outcome [2]
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Evidence of gout deposition (double contour sign, tophi, aggregates) by ultrasound
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Assessment method [2]
341347
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Timepoint [2]
341347
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [3]
341348
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Presence of crystal deposition assessed by Dual energy computertomography (DECT)
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Assessment method [3]
341348
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Timepoint [3]
341348
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Baseline, 12, and 24 months
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Secondary outcome [4]
341349
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Serum urate levels
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Assessment method [4]
341349
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Timepoint [4]
341349
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Monthly for 12 months, 24 months
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Secondary outcome [5]
341350
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Patient reported outcome measures (PROMS):
Joint pain due to gout (Numeric rating scale 0-10)
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Assessment method [5]
341350
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Timepoint [5]
341350
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [6]
341351
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Joint pain (Numeric rating scale 0-10)
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Assessment method [6]
341351
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Timepoint [6]
341351
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [7]
341352
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Fatigue (Numeric rating scale 0-10)
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Assessment method [7]
341352
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Timepoint [7]
341352
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [8]
341353
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Patient global assessment of gout condition (Numeric rating scale 0-10)
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Assessment method [8]
341353
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Timepoint [8]
341353
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [9]
341354
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Patient global response to therapy (5-point Likert scale)
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Assessment method [9]
341354
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Timepoint [9]
341354
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [10]
341355
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Patient acceptable symptom state (to levels: "Acceptable" or "Unacceptable")
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Assessment method [10]
341355
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Timepoint [10]
341355
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [11]
341356
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General health (5-point Likert scale)
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Assessment method [11]
341356
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Timepoint [11]
341356
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [12]
341357
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Health Assessment Questionnaire (HAQ)
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Assessment method [12]
341357
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Timepoint [12]
341357
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [13]
341358
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Helath related quality of life with Short form 36 (SF-36)
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Assessment method [13]
341358
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Timepoint [13]
341358
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [14]
341359
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Utility (EQ-5D-5L) using Euro-QoL with 5 questions and 5 levels.
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Assessment method [14]
341359
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Timepoint [14]
341359
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [15]
341360
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Arthritis Self-efficacy Scales (ASES)
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Assessment method [15]
341360
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Timepoint [15]
341360
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [16]
341361
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Catastrophizing of pain questionnaire (Norwegian Society of Pain)
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Assessment method [16]
341361
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Timepoint [16]
341361
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [17]
341362
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Beliefs about medicines questionnaire (BMQ)
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Assessment method [17]
341362
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Timepoint [17]
341362
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Baseline, 3, 6, 12, 24 months
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Secondary outcome [18]
341363
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Self-report questionnaire on work activity and history (WPAI)
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Assessment method [18]
341363
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Timepoint [18]
341363
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Baseline, 3, 6, 12, 24 months
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Eligibility
Key inclusion criteria
a) Classification of gout with urate crystals demonstrated in joint fluid or tophus
b) Acute gout attack during the last month
c) Increased serum urate level
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
a.) Severe co-morbidity, including heart failure (NYHA III-IV) or kidney failure (eGFR<45 ml/min, CKD stage 3B)
b.) Inability to comply with the protocol requirements
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The applied statistics will mainly use descriptive methods but also multivariate models, applying data analysis with SPSS, for example regression analysis to test prognostic factors. Repeated measurements during the study will allow analyses with mixed models.
For a hypothesized reduction in gout flare frequency from 20% in prevalent gout patients to 10% during months 9-12 when applying an alpha of 0.05 and strength of beta 0.8 a sample size of around 200 patients is needed, assuming a low, and thus conservative, intra-subject correlation between serum urate measurements.
To show an intragroup clinically important reduction in serum urate (60µmol/L) with alpha 0.05 and beta 0.8, 150 patients are needed.
Sample sizes for the imaging outcomes cannot be calculated, as there have so far been no studies from clinical practice which have examined the resolution of MSU crystals depositions.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/09/2015
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Date of last participant enrolment
Anticipated
1/09/2018
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Actual
14/09/2018
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Date of last data collection
Anticipated
3/12/2023
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Actual
1/11/2023
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Sample size
Target
200
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Accrual to date
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Final
163
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Recruitment outside Australia
Country [1]
9439
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Norway
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State/province [1]
9439
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Oslo
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Funding & Sponsors
Funding source category [1]
298224
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Hospital
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Name [1]
298224
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Diakonhjemmet Hospital
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Address [1]
298224
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Postbox 23 Vinderen
N-0319 Oslo
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Country [1]
298224
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Norway
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Funding source category [2]
313429
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Government body
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Name [2]
313429
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Norwegian Research Council (no. 328657)
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Address [2]
313429
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Drammensveien 288, 0283 Oslo, Norway
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Country [2]
313429
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Norway
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Primary sponsor type
Hospital
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Name
Diakonhjemmet Hospital
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Address
Postbox 23 Vinderen
N-0319 Oslo
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Country
Norway
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Secondary sponsor category [1]
298438
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None
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Name [1]
298438
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Address [1]
298438
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Country [1]
298438
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299232
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Regional Ethics commitee (REK sørøst)
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Ethics committee address [1]
299232
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Gullhaugveien 1-3
N-0484 Oslo
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Ethics committee country [1]
299232
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Norway
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Date submitted for ethics approval [1]
299232
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12/05/2015
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Approval date [1]
299232
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01/07/2015
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Ethics approval number [1]
299232
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2015/990
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Summary
Brief summary
The current management of gout is far from optimal in both primary and also in specialised health care. Treatment with focus on the acute gout attack has too often led to a lack of emphasis on persistent long-term treatment, even though we know that the disease is curable.
In this study we examine whether a treat-to-target approach, applying recent advances in disease management is feasible for clinical practice. Our hypothesis is that this will prevent new gout attacks, lower serum urate to target in most patients and thereby and also remove of urate deposits from joints and tendons.
Assessments include a broad spectrum of clinical measures, questionnaires, advanced imaging methods and cardiovascular assessment.
The study will greatly benefit patients and improve gout care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
79742
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Prof Till Uhlig
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Address
79742
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Dept. of Rheumatology
Diakonhjemmet Hospital
Postbox. 23 Vinderen
N-0319 Oslo
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Country
79742
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Norway
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Phone
79742
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+4722451500
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Fax
79742
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Email
79742
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[email protected]
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Contact person for public queries
Name
79743
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Prof Till Uhlig
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Address
79743
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Dept. of Rheumatology
Diakonhjemmet Hospital
Postbox 23 Vinderen
N-0319 Oslo
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Country
79743
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Norway
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Phone
79743
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+4722451500
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Fax
79743
0
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Email
79743
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[email protected]
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Contact person for scientific queries
Name
79744
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Prof Till Uhlig
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Address
79744
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Dept. of Rheumatology
Diakonhjemmet Hospital
Postbox 23 Vinderen
N-0319 Oslo
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Country
79744
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Norway
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Phone
79744
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+4722451500
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Fax
79744
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Email
79744
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Hammer HB, Karoliussen L, Terslev L, Haavardsholm ...
[
More Details
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Study results article
Yes
Hammer HB, Karoliussen LF, Terslev L, Haavardsholm...
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More Details
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Study results article
Yes
Uhlig et al. RMD Open 2021 12-month results from ...
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More Details
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Study results article
Yes
UhligT et al. Rheumatology 2022 Two-year reductio...
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More Details
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Study results article
Yes
Uhlig T et al. Arthritis Res Ther 2022 One- and 2...
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More Details
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Study results article
Yes
Hammer HB, Rollefstad S, Semb AG, Jensen G, Karoli...
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More Details
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Study results article
Yes
Uhlig T, Karoliussen LF, Sexton J, Kvien TK, Haava...
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More Details
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Study results article
Yes
Uhlig T, Karoliussen LF, Sexton J, Provan SA, Kvie...
[
More Details
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Study results article
Yes
Uhlig T, Karoliussen LF, Sexton J, Kvien TK, Haava...
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More Details
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Study results article
Yes
Uhlig T, Karoliussen LF, Sexton J, Kvien TK, Haava...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Ultrasound shows rapid reduction of crystal depositions during a treat-to-target approach in gout patients: 12-month results from the NOR-Gout study.
2020
https://dx.doi.org/10.1136/annrheumdis-2020-217392
Embase
12-month results from the real-life observational treat-to-target and tight-control therapy NOR-Gout study: Achievements of the urate target levels and predictors of obtaining this target.
2021
https://dx.doi.org/10.1136/rmdopen-2021-001628
Embase
Course and predictors of work productivity in gout - results from the NOR-Gout longitudinal 2-year treat-to-target study.
2023
https://dx.doi.org/10.1093/rheumatology/kead124
Embase
Lifestyle factors predict gout outcomes: Results from the NOR-Gout longitudinal 2-year treat-to-target study.
2023
https://dx.doi.org/10.1136/rmdopen-2023-003600
Embase
Beliefs about medicines in gout patients: results from the NOR-Gout 2-year study.
2023
https://dx.doi.org/10.1080/03009742.2023.2213507
Embase
Two-year reduction of dual-energy CT urate depositions during a treat-to-target strategy in gout in the NOR-Gout longitudinal study.
2022
https://dx.doi.org/10.1093/rheumatology/keab533
N.B. These documents automatically identified may not have been verified by the study sponsor.
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