Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels
- Registration Number
- NCT02060552
- Lead Sponsor
- Tongji Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Febuxostat Febuxostat Febuxostat 40mg once a day Febuxostat plus diacerein Diacerein Febuxostat 40mg once a day plus diacerein 50mg twice a day Febuxostat plus diacerein Febuxostat Febuxostat 40mg once a day plus diacerein 50mg twice a day Febuxostat plus Colchicine Colchicine Febuxostat 40mg once a day plus Colchicine 0.5mg twice a day Febuxostat plus Colchicine Febuxostat Febuxostat 40mg once a day plus Colchicine 0.5mg twice a day
- Primary Outcome Measures
Name Time Method Patients'intensity of pain 12 weeks Patients' intensity of pain was assessed at each visit by a single question using a 100mm visual analogue scale (VAS). The pain question was how much pains have you had because of your illness in the past seven days? The two anchors were no pain (0 score) and unbearable pain (score of 100). Patients were instructed to draw a vertical mark on the scaleline and the investigator measured the length and recorded the result.
Acute gout flare times 24 weeks Acute gout flare was defined by pain, redness, swelling, and warmth on joints or adjacent soft tissue and pain VAS more than 3.0. For subsequent gout flares, subjects were recorded events by themselves and were reported to investigator whether they had any new or recurrent gout flares since their last visit
- Secondary Outcome Measures
Name Time Method HAQ 12 weeks Healthy Assessment Questionnaire (HAQ) disability index might be valuable to assess the joints function impaired by gout flares.HAQ comprised twenty questions and each question has a corresponding mark : 0, 1 or 2. Sum of each answer of the questions was divided by 20
Flow Cytometry analysis on cell markers 12 weeks Inhibitory T cell:CD4 Help T cell:CD8 Natural Killer cell:CD56,CD69，CD16 and CD25 (CD 56 dim and CD56 bright) B cell:CD19 and CD20
Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC 12 weeks IL-1β,IL-18, IL-10
Serum concentration of inflammatory cytokines 12 weeks IL-1β，IL-10，IL-6 and IL-8 etc.
Serum and urine urate concentration 24 weeks serum urate concentration and 24h urine urate concentration
Trial Locations
- Locations (1)
Yikai YU
🇨🇳Wuhan, Hubei, China