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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 provided
20/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gout in Norway (NOR-Gout)
Scientific title
Gout in Norway (NOR-Gout) - Treating patients with gout to target serum urate
Secondary ID [1] 293609 0
None
Universal Trial Number (UTN)
U1111-1206-6335
Trial acronym
NOR-Gout
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 305872 0
Condition category
Condition code
Musculoskeletal 305070 305070 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 305816 305816 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299865 0
Lifestyle
Intervention code [2] 299866 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304244 0
Percentage of patients reaching the treatment target for serum urate of <360 micromol/l (300 micromol/l if tophi).
Timepoint [1] 304244 0
Primary outcome: Month 12
Primary outcome [2] 304245 0
Percentage of patients with no self-reported gout flares
Timepoint [2] 304245 0
During months 9-12. Self-reported and assessed over the three-month period at month 12.
Secondary outcome [1] 341346 0
Cardiovascular assessment: Transthoracic echocardiography of the heart and B-mode ultrasonography examination of the carotid arteries bilaterally including plaque echolucency.
Timepoint [1] 341346 0
Baseline
Secondary outcome [2] 341347 0
Evidence of gout deposition (double contour sign, tophi, aggregates) by ultrasound
Timepoint [2] 341347 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [3] 341348 0
Presence of crystal deposition assessed by Dual energy computertomography (DECT)
Timepoint [3] 341348 0
Baseline, 12, and 24 months
Secondary outcome [4] 341349 0
Serum urate levels
Timepoint [4] 341349 0
Monthly for 12 months, 24 months
Secondary outcome [5] 341350 0
Patient reported outcome measures (PROMS):
Joint pain due to gout (Numeric rating scale 0-10)
Timepoint [5] 341350 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [6] 341351 0
Joint pain (Numeric rating scale 0-10)
Timepoint [6] 341351 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [7] 341352 0
Fatigue (Numeric rating scale 0-10)
Timepoint [7] 341352 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [8] 341353 0
Patient global assessment of gout condition (Numeric rating scale 0-10)
Timepoint [8] 341353 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [9] 341354 0
Patient global response to therapy (5-point Likert scale)
Timepoint [9] 341354 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [10] 341355 0
Patient acceptable symptom state (to levels: "Acceptable" or "Unacceptable")
Timepoint [10] 341355 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [11] 341356 0
General health (5-point Likert scale)
Timepoint [11] 341356 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [12] 341357 0
Health Assessment Questionnaire (HAQ)
Timepoint [12] 341357 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [13] 341358 0
Helath related quality of life with Short form 36 (SF-36)
Timepoint [13] 341358 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [14] 341359 0
Utility (EQ-5D-5L) using Euro-QoL with 5 questions and 5 levels.
Timepoint [14] 341359 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [15] 341360 0
Arthritis Self-efficacy Scales (ASES)
Timepoint [15] 341360 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [16] 341361 0
Catastrophizing of pain questionnaire (Norwegian Society of Pain)
Timepoint [16] 341361 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [17] 341362 0
Beliefs about medicines questionnaire (BMQ)
Timepoint [17] 341362 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [18] 341363 0
Self-report questionnaire on work activity and history (WPAI)
Timepoint [18] 341363 0
Baseline, 3, 6, 12, 24 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
1/09/2018
Actual
14/09/2018
Date of last data collection
Anticipated
3/12/2023
Actual
1/11/2023
Sample size
Target
200
Accrual to date
Final
163
Recruitment outside Australia
Country [1] 9439 0
Norway
State/province [1] 9439 0
Oslo

Funding & Sponsors
Funding source category [1] 298224 0
Hospital
Name [1] 298224 0
Diakonhjemmet Hospital
Country [1] 298224 0
Norway
Funding source category [2] 313429 0
Government body
Name [2] 313429 0
Norwegian Research Council (no. 328657)
Country [2] 313429 0
Norway
Primary sponsor type
Hospital
Name
Diakonhjemmet Hospital
Address
Postbox 23 Vinderen
N-0319 Oslo
Country
Norway
Secondary sponsor category [1] 298438 0
None
Name [1] 298438 0
Address [1] 298438 0
Country [1] 298438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299232 0
Regional Ethics commitee (REK sørøst)
Ethics committee address [1] 299232 0
Ethics committee country [1] 299232 0
Norway
Date submitted for ethics approval [1] 299232 0
12/05/2015
Approval date [1] 299232 0
01/07/2015
Ethics approval number [1] 299232 0
2015/990

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79742 0
Prof Till Uhlig
Address 79742 0
Dept. of Rheumatology
Diakonhjemmet Hospital
Postbox. 23 Vinderen
N-0319 Oslo
Country 79742 0
Norway
Phone 79742 0
+4722451500
Fax 79742 0
Email 79742 0
[email protected]
Contact person for public queries
Name 79743 0
Till Uhlig
Address 79743 0
Dept. of Rheumatology
Diakonhjemmet Hospital
Postbox 23 Vinderen
N-0319 Oslo
Country 79743 0
Norway
Phone 79743 0
+4722451500
Fax 79743 0
Email 79743 0
[email protected]
Contact person for scientific queries
Name 79744 0
Till Uhlig
Address 79744 0
Dept. of Rheumatology
Diakonhjemmet Hospital
Postbox 23 Vinderen
N-0319 Oslo
Country 79744 0
Norway
Phone 79744 0
+4722451500
Fax 79744 0
Email 79744 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUltrasound shows rapid reduction of crystal depositions during a treat-to-target approach in gout patients: 12-month results from the NOR-Gout study.2020https://dx.doi.org/10.1136/annrheumdis-2020-217392
Embase12-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.2021https://dx.doi.org/10.1136/rmdopen-2021-001628
EmbaseTwo-year reduction of dual-energy CT urate depositions during a treat-to-target strategy in gout in the NOR-Gout longitudinal study.2022https://dx.doi.org/10.1093/rheumatology/keab533
EmbaseBeliefs about medicines in gout patients: results from the NOR-Gout 2-year study.2023https://dx.doi.org/10.1080/03009742.2023.2213507
EmbaseCourse and predictors of work productivity in gout - results from the NOR-Gout longitudinal 2-year treat-to-target study.2023https://dx.doi.org/10.1093/rheumatology/kead124
EmbaseLifestyle factors predict gout outcomes: Results from the NOR-Gout longitudinal 2-year treat-to-target study.2023https://dx.doi.org/10.1136/rmdopen-2023-003600
N.B. These documents automatically identified may not have been verified by the study sponsor.