Go Test Finale

2024-511111-13-01 Therapeutic use (Phase IV) Ended

Start 9 Jul 2024 · End 16 Jun 2025 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 310
Countries 1
Sites 1

Gout

1) To assess the between strategy difference in proportion of participants fulfilling adapted preliminary gout remission criteria (no tophi, no flares, NRS pain due to gout <2 and disease activity <2, but independent of sUA level), during the last six months of the 24 month follow-up period. 2) To assess the increment…

Key facts

Sponsor
Sint Maartenskliniek
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
9 Jul 2024 → 16 Jun 2025
Decision date (initial)
2024-07-09
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

1) To assess the between strategy difference in proportion of participants fulfilling adapted preliminary gout remission criteria (no tophi, no flares, NRS pain due to gout <2 and disease activity <2, but independent of sUA level), during the last six months of the 24 month follow-up period.
2) To assess the incremental cost-effectiveness in euro per QALY gained for T2T compared to T2S.

Conditions and MedDRA coding

Gout

VersionLevelCodeTermSystem organ class
20.0 LLT 10003257 Arthritis gouty 10028395
21.0 LLT 10003435 Articular gout 10027433
20.0 PT 10018627 Gout 100000004861
20.0 PT 10018627 Gout 100000004861
21.0 LLT 10003435 Articular gout 10027433
20.0 LLT 10003257 Arthritis gouty 10028395
21.1 LLT 10064900 Gout flare 10027433

Regulatory references

Plan to share IPD
Yes
IPD plan description
Data will be handled according to FAIR principles. After completion of the study, data will be available on reasonable request by contacting the corresponding author. The request will be reviewed by the trial steering committee.
EU CT numberTitleSponsor
2024-511111-13-00 GOut TrEatment STrategy (GO TEST) FINALE study, a multicentre pragmatic randomized superiority trial of continuation versus cessation of urate lowering therapies in gout in remission. Sint Maartenskliniek

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. - Patients with clinical diagnosis of gout and/or fulfilling the 2015 ACR-EULAR gout criteria
  2. - Use of ULT (allopurinol, benzbromarone and/or febuxostat)
  3. 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
  4. Age ≥18 years and mentally competent
  5. Signed written informed consent

Exclusion criteria 6

  1. - Not being able to speak, read or write Dutch well enough
  2. 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)
  3. A strong contra-indication for glucocorticoids, NSAIDs AND colchicine, as this hampers flare treatment
  4. Use of ULT (also) for any other indication than gout (for example nephrolithiasis)
  5. 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
  6. A history of myocardial infarction or stroke in the past six months and/or congestive heart failure NYHA class III or IV

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The between group difference in proportion of patients fulfilling the adapted preliminary gout remission criteria during the last 6 months of 24 month follow up using superiority testing. If superiority is not shown, non-inferiority testing with a prespecified NI margin of 0.08 will be performed exploratory as secondary outcome.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

—

SCP132779 · ATC

Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
300 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
M04AB03 — BENZBROMARONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Allopurinol

SCP130703 · ATC

Active substance
Allopurinol
Route of administration
ORAL
Max daily dose
900 mg milligram(s)
Max total dose
900 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
M04AA01 — ALLOPURINOL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Febuxostat Hemihydrate

SCP104873455 · ATC

Active substance
Febuxostat Hemihydrate
Route of administration
ORAL
Max daily dose
120 mg milligram(s)
Max total dose
120 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
M04AA03 — FEBUXOSTAT
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Maartenskliniek

2 Total trials 1 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Sint Maartenskliniek
Address
Hengstdal 3
City
Ubbergen
Postcode
6574 NA
Country
Netherlands

Scientific contact point

Organisation
Sint Maartenskliniek
Contact name
Iris Rose Peeters

Public contact point

Organisation
Sint Maartenskliniek
Contact name
Iris Rose Peeters

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ended 310 1
Rest of world — 0 —

Investigational sites

Netherlands

1 site · Ended
Sint Maartenskliniek Stichting
Rheumatology, Hengstdal 3, 6574 NA, Ubbergen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2024-07-09 2025-06-16

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Summary of results GO Test Finale
SUM-136724
 2026-05-30T13:50:51 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Lay Summary of Results 2026-05-30T13:51:22 Submitted Laypersons Summary of Results

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) LaySummaryGOTESTFinale 1
Protocol (for publication) D_Protocol 2024-511111-13-01 11
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICD Go Test Finale substudy 1
Subject information and informed consent form (for publication) L1_SIS and ICF Go Test Finale 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_ SmPC Benzbromaron 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC allopurinol 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC febuxostat 1
Summary of results (for publication) LaySummaryGOTESTFinale 1
Summary of results (for publication) Summaryofresultsgotestfinale 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-28 Netherlands Acceptable with conditions
2024-07-09
 2024-07-09