Anakinra versus treatment as usual in the treatment of acute gout

Anakinra versus treatment as usual in the treatment of acute gout - ATTACG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000696-27-NL

Enrollment

200

Registered

2015-06-12

Start date

2015-08-06

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Interventions

Trade Name: Kineret Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • At least 18 years of age • Signed written informed consent • Identification of intracellular monosodium urate crystals in primary joint through aspiration of joint Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: • Absolute contra-indication for urate lowering therapy • Absolute contra-indication for anakinra • Presence of liver disease that according to the treating physician precludes participation in the study • Absolute contra-indication for all three possible standard of care treatments (colchicine, naproxen, prednisolon) • Known history of allergy or sensitivity to latex • Current use of any ULT • Concurrent use of other IL-1 agents • Patient reports no to mild gout related pain • Pregnancy or lactation • Women who are planning on becoming pregnant within the study period (12 months) • Patients with active or recurrent bacterial, fungal or viral infection • Patients using tumor necrosis factor inhibitors • Patient has insufficient knowledge of the Dutch language for completing questionnaire independently

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary objectives are to compare the cost per quality-adjusted life day between anakinra and standard of care and to evaluate the safety of ankinra use in gout. Also to compare the 3 and 12 months clinical outcome of patients initially treated with anakinra versus Standard of care and starting Urate lowering therapy.;Main Objective: The primary aim of this research is to demonstrate the noninferiority of anakinra compared with the standard of care in the treatment of acute gout flares.;Primary end point(s): Change in patient-reported pain in the index joint from baseline to the average of pain values at 24, 48 and 72 hours ;Timepoint(s) of evaluation of this end point: After 3 days	—

Measure

Time frame

Secondary Objective: Secondary objectives are to compare the cost per quality-adjusted life day between anakinra and standard of care and to evaluate the safety of ankinra use in gout. Also to compare the 3 and 12 months clinical outcome of patients initially treated with anakinra versus Standard of care and starting Urate lowering therapy.;Main Objective: The primary aim of this research is to demonstrate the noninferiority of anakinra compared with the standard of care in the treatment of acute gout flares.;Primary end point(s): Change in patient-reported pain in the index joint from baseline to the average of pain values at 24, 48 and 72 hours ;Timepoint(s) of evaluation of this end point: After 3 days

—

Secondary

Measure	Time frame
Secondary end point(s): Time to 50% reduction in pain in the primary affected joint Time to remission of pain Decrease of primary joint swelling according to patient across day 2-5 Decrease of primary joint tenderness according to patient across day 2-5 Decrease in C-reactive protein (CRP) levels after 7 days of treatment Treatment response according to patient across day 2 -7 % dropout due to adverse event (AE) % dropout due to serious adverse event (SAE) Level of physical functioning Health related quality of life (HR-QOL) Experienced side effects Direct and indirect costs Time to first reoccurrence of flare Number of new flares % patients starting with canakinumab treatment % patients with serum uric acid concentration = 0.36 mmol/l ;Timepoint(s) of evaluation of this end point: Day 7, month 3, 6, 9 and 12	—

Measure

Time frame

Secondary end point(s): Time to 50% reduction in pain in the primary affected joint Time to remission of pain Decrease of primary joint swelling according to patient across day 2-5 Decrease of primary joint tenderness according to patient across day 2-5 Decrease in C-reactive protein (CRP) levels after 7 days of treatment Treatment response according to patient across day 2 -7 % dropout due to adverse event (AE) % dropout due to serious adverse event (SAE) Level of physical functioning Health related quality of life (HR-QOL) Experienced side effects Direct and indirect costs Time to first reoccurrence of flare Number of new flares % patients starting with canakinumab treatment % patients with serum uric acid concentration = 0.36 mmol/l ;Timepoint(s) of evaluation of this end point: Day 7, month 3, 6, 9 and 12

—

Countries

Netherlands

Contacts

Public ContactPhD Student

University of Twente

c.a.janssen@utwente.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026