Back to resultsImmune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels
Primary Purpose
Primary Gout
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Diacerein
Colchicine
Febuxostat
Sponsored by
About this trial
This is an interventional treatment trial for Primary Gout
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.
Sites / Locations
- Yikai YU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Febuxostat
Febuxostat plus diacerein
Febuxostat plus Colchicine
Arm Description
Febuxostat 40mg once a day
Febuxostat 40mg once a day plus diacerein 50mg twice a day
Febuxostat 40mg once a day plus Colchicine 0.5mg twice a day
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Serum and urine urate concentration
serum urate concentration and 24h urine urate concentration
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
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
Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC
IL-1β,IL-18, IL-10
Serum concentration of inflammatory cytokines
IL-1β，IL-10，IL-6 and IL-8 etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02060552
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Febuxostat
Arm Type
Placebo Comparator
Arm Description
Febuxostat 40mg once a day
Arm Title
Febuxostat plus diacerein
Arm Type
Experimental
Arm Description
Febuxostat 40mg once a day plus diacerein 50mg twice a day
Arm Title
Febuxostat plus Colchicine
Arm Type
Experimental
Arm Description
Febuxostat 40mg once a day plus Colchicine 0.5mg twice a day
Intervention Type
Drug
Intervention Name(s)
Diacerein
Other Intervention Name(s)
Diacetylrhein
Intervention Description
oral administration of IL-1βinhibitory
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
Colcrys, Generics
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
No other names
Intervention Description
A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout
Primary Outcome Measure Information:
Title
Patients'intensity of pain
Description
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.
Time Frame
12 weeks
Title
Acute gout flare times
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Serum and urine urate concentration
Description
serum urate concentration and 24h urine urate concentration
Time Frame
24 weeks
Title
HAQ
Description
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
Time Frame
12 weeks
Title
Flow Cytometry analysis on cell markers
Description
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
Time Frame
12 weeks
Title
Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC
Description
IL-1β,IL-18, IL-10
Time Frame
12 weeks
Title
Serum concentration of inflammatory cytokines
Description
IL-1β，IL-10，IL-6 and IL-8 etc.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoxian HU, Doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yikai YU
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Learn more about this trial
Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels
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