Clinical trial NCT02060552: Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels
Official title: Diacerein Combined With Febuxostat Relieves Symptoms of Gout by Suppressing IL-1βinflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Gout
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of study was to assess the efficiency and safety of oral IL-1βinhibitor in combination with urate lowering therapy on joint pain intensity,urate control, global assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers and symptoms improving related life quantity in gouty patients.

Detailed description: This was a randomized single-dose, open-label and active-controlled study which was carried out in 96 primary gout patients. Subjects and doctors have no access to randomization sequence which is determined by the primary investigator.All patients received an open-label febuxostat 40mg daily during the whole study. Healthy control were 32 age-matched men from volunteers in the medical health center.Two primary end points included pain intensity measurement which was recorded at each visit and subsequently acute flare times which was recorded at home and reported to investigator.

Eligibility criteria: Inclusion Criteria:

All participants who were allocated to the study all had a history of taking tolerable and adequate dose of urate lowering therapy including febuxostat 40-80mg daily or allopurinol 200-300 mg daily for at least 4 weeks and were defined as difficult to treat or refractory gout patients. All patients had a negative of rheumatoid factor and antinuclear antibody, Hb\>100g/L, total leukocyte count≥3.5×109, PLT≥80×109, serum creatinine\<133umol/L, transaminases\<60U/L and fasting urate≥6.0mg/dL.

Inclusion criteria for the gouty patients were age≥18 years old, BMI(18-30kg/m2). All participants enrolled in our study fulfilled American College of Rheumatology criteria for primary gout.

Exclusion Criteria:

Exclusion criteria included secondary gout (because it is always associated with some underlying renal disease), a history of congestive heart failure, serum creatinine≥133umol/L (because the patients have underlying risks if NSAID needed) or the use of glucocorticoid\>15mg daily,colchicine, uricosuric drugs, chemotherapy or immunosuppressive therapy in the past three months.

Primary outcomes:
measure: Patients'intensity of pain
timeFrame: 12 weeks
measure: Acute gout flare times
timeFrame: 24 weeks
Secondary outcomes:
measure: Serum and urine urate concentration
timeFrame: 24 weeks
measure: HAQ
timeFrame: 12 weeks
measure: Flow Cytometry analysis on cell markers
timeFrame: 12 weeks
measure: Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC
timeFrame: 12 weeks
measure: Serum concentration of inflammatory cytokines
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Yikai YU
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Shaoxian HU, Doctor
role: PRINCIPAL_INVESTIGATOR
References: