Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels

Primary Gout Clinical Trial

Official title:

Diacerein Combined With Febuxostat Relieves Symptoms of Gout by Suppressing IL-1βinflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060552
• Other study ID #: Diagout1
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2014
• Last updated: May 7, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout
• Primary Gout

Intervention

Drug:
• Diacerein
oral administration of IL-1ßinhibitory
• Colchicine
Colchicine is a toxic natural product and secondary metabolite, originally extracted from plants of the genus Colchicum (autumn crocus, Colchicum autumnale, also known as "meadow saffron"). It was used originally to treat rheumatic complaints, especially gout as the positive control
• Febuxostat
A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout

Locations

Country	Name	City	State
China	Yikai YU	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients'intensity of pain	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.	12 weeks	No
Primary	Acute gout flare times	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	24 weeks	No
Secondary	Serum and urine urate concentration	serum urate concentration and 24h urine urate concentration	24 weeks	No
Secondary	HAQ	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	12 weeks	No
Secondary	Flow Cytometry analysis on cell markers	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	12 weeks	Yes
Secondary	Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC	IL-1ß,IL-18, IL-10	12 weeks	Yes
Secondary	Serum concentration of inflammatory cytokines	IL-1ß,IL-10,IL-6 and IL-8 etc.	12 weeks	Yes