To test whether the proportion of patients in remission during the last 6 months of follow up is higher for a T2T strategy compared to a T2S stop strategy.
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
Synonym
Health condition
Inflammatoire artritis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the difference in proportion of patients fulfilling an
adapted version of the preliminary remission criteria for gout (no tophi, no
flares, NRS pain due to gout < 2, NRS gout disease activity <2) over the last
six months of 24 months follow up between the T2T and T2S strategy group. The
adaptation consist of omitting the SU target < 0.36 prerequisite, as this
surrogate outcome measure is of course not a realistic goal when
comparing T2T and T2S.
Secondary outcome
- Non-inferiority of T2S compared to T2T with a predefined NI-margin of 0.08,
in case superiority of T2T over T2S is not shown in the primary analysis.
* The incremental cost-effectiveness of T2T over T2S treatment strategy in euro
per QALY gained, by using the results of EQ-5D-5L, iMCQ, iPCQ and medication
costs
- The between group difference in the incidence (cumulative incidence and
incidence density rate) of gout flares during the follow-up period of 24 months
- The proportion of participants that require reintroduction of ULT in the T2S
group during the 24 month follow-up period
- The between group difference in SU change during the total follow-up time and
particularly at baseline and at the end of follow-up at 24 months
- The between group difference in PROMs at baseline and after 24 months by
using the EQ-5D5L, HAQ-II, NRS pain, and NRS global health
- The between group difference in types and frequency of adverse events, with
special focus on change in renal function (CKD-EPI), incidence of
cardiovascular events during the followup period of 24 months
- The between group difference in use of ULT and flare medication (colchicine,
NSAIDs and/or prednisone)
- The (between group) difference in prescribed medication compared with refill
rates during the follow-up period of 24 months
- An overview of predictors for successful ULT cessation in the T2S strategy
group including
clinical, radiological and immunological variables.
- The creation of a biobank consisting of serum, plasma and PAXgene samples of
gout patients in remission (dis)continuing ULT
Background summary
Urate lowering therapies (ULT), such as allopurinol, benzbromarone and
febuxostat are prescribed in patients with gout to lower serum urate (SU)
levels to reduce the state of hyperuricemia and by that the risk of synovial
inflammation due to crystal depositions. Rheumatology guidelines, nationally
and internationally, recommend the use of ULT by the so-called treat-to-target
strategy (T2T); SU levels should be <0.36mmol/l or even <0.30 mmol/l in the
presence of tophi, chronic arthropathy and/or frequent flares, by increasing or
combining medicines until the target has been reached. Due to the chronicity of
gout, the high safety and low costs of ULT, most experts therefore advise to
use ULT lifelong. However, a different, frequently used method (mainly by
patients themselves or general practitioners, GPs) is the treat-to-symptoms
stop strategy (T2S), which only aims at a patient acceptable symptom state,
regardless of SU levels. ULT is stopped when symptoms are absent and restarted
when gout flares reoccur. Although continuing the T2T strategy lifelong is
mostly thought to be superior to the T2S strategy, this has not been
investigated before.
Study objective
To test whether the proportion of patients in remission during the last 6
months of follow up is higher for a T2T strategy compared to a T2S stop
strategy.
Study design
The GO TEST FINALE study is a pragmatic, two-arm, randomized, open label,
superiority treatment strategy trial in gout patients who are in remission >= 12
months while using ULT. After inclusion participants will be randomized 1:1 to
either the T2T strategy group or the T2S strategy group Patients are followed
for 24 months.
Intervention
The intervention group employs the T2T strategy, in which ULT are continued and
a SU target of <0.36mmol/l is aimed for.
The control group follows a T2S strategy, in which ULT are tapered to stop
regardless of SU values. In case of >1 flare or a flare duration of >1 week
under adequate flare treatment during follow-up time, ULT are restarted using
the last effective drug and dose, and a SU target <0.36mmol/l is pursued again.
Study burden and risks
In regular gout follow-up, patients would be monitored with a visit and blood
samples once every one or two years, so our schedule is in line with usual gout
care. Three monthly digital questionnaires are sent and flares are monthly
monitored digitally. Extra care visits can be scheduled in case of flaring, ULT
intensification or restarting of ULT. The main risk of participation is a gout
flare due to discontinuation of ULT, this may lead to pain and the possibility
of short sick leave and adverse events due to flare treatment. To prevent rapid
SU changes, which may trigger (cardiovascular) gout flares, ULT are tapered to
stop instead of directly stopped.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a participant must meet all of the
following criteria:
- Patients with clinical diagnosis of gout and/or fulfilling the 2015 ACR-EULAR
gout criteria
- Use of ULT (allopurinol, benzbromarone and/or febuxostat)
- Achieved remission for >= 12 months based on adapted preliminary gout
remission criteria
(29).
o Free of flares and/or clinically apparent tophi during the last 12 months
o Serum urate <=0.36 mmol/l at baseline and all values in the last 12 months
should not
be >0.36 mmol/l
o Pain due to gout <2 using a 10-point Likert-type scale at baseline
o Patient global assessment of gout disease activity <2 using a 10-point
Likert-type
scale at baseline
- Age >=18 years and mentally competent
- Signed written informed consent
Exclusion criteria
A potential participant will be excluded from participation in this study if
one of the following
criteria has been met:
- Not being able to speak, read or write Dutch well enough
- No ability to measure the outcome of the study in the participant (e.g. life
expectancy <2 years,
planned relocation out of reach of study center)
- A strong contra-indication for glucocorticoids, NSAIDs AND colchicine, as
this hampers flare
treatment
- Use of ULT (also) for any other indication than gout (for example
nephrolithiasis)
- Currently taking regular glucocorticoids, and/or colchicine, and/or
interleukine-1 inhibitors for
any diagnosis and/or the use of regular NSAID intake for gout activity
- A history of myocardial infarction or stroke in the past six months and/or
congestive heart failure NYHA class III or IV
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-005730-15-NL |
| CCMO | NL74350.091.20 |
| Other | Trial NL9245 |
| OMON | NL-OMON20243 |