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

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ClinicalTrials.gov Identifier: NCT02060552
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Yikai Yu, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE February 8, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date May 8, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • Patients'intensity of pain [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2014)
  • Patients'intensity of pain [ Time Frame: 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 invesigator measured the length and recorded the result.
  • Acute gout flare times [ Time Frame: 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 invesigator whether they had any new or recurrent gout flares since their last visit
Change History Complete list of historical versions of study NCT02060552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • Serum and urine urate concentration [ Time Frame: 24 weeks ]
    serum urate concentration and 24h urine urate concentration
  • HAQ [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]
    IL-1β,IL-18, IL-10
  • Serum concentration of inflammatory cytokines [ Time Frame: 12 weeks ]
    IL-1β,IL-10,IL-6 and IL-8 etc.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2014)
  • Serum and urine urate concentration [ Time Frame: 24 weeks ]
    serum urate concentration and 24h urine urate concentration
  • HAQ [ Time Frame: 12 weeks ]
    Healty Assessment Questionnair (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 divied by 20
  • Flow Cytometry analysis on cell markers [ Time Frame: 12 weeks ]
    Inhibitory T cell:CD4 Help T cell:CD8 NK cell:CD56,CD69(CD 56 dim and CD56 bright) B cell:CD19 and CD20
  • Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC [ Time Frame: 12 weeks ]
    IL-1β,IL-18, IL-10
  • Serum concentration of inflammatory cytokines [ Time Frame: 12 weeks ]
    IL-1β,IL-10,IL-6 and IL-8 etc.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels
Official Title  ICMJE Diacerein Combined With Febuxostat Relieves Symptoms of Gout by Suppressing IL-1βinflammation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Gout
Intervention  ICMJE
  • Drug: Diacerein
    oral administration of IL-1βinhibitory
    Other Name: Diacetylrhein
  • Drug: 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
    Other Names:
    • Colcrys
    • Generics
  • Drug: Febuxostat
    A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout
    Other Name: No other names
Study Arms  ICMJE
  • Placebo Comparator: Febuxostat
    Febuxostat 40mg once a day
    Intervention: Drug: Febuxostat
  • Experimental: Febuxostat plus diacerein
    Febuxostat 40mg once a day plus diacerein 50mg twice a day
    Interventions:
    • Drug: Diacerein
    • Drug: Febuxostat
  • Experimental: Febuxostat plus Colchicine
    Febuxostat 40mg once a day plus Colchicine 0.5mg twice a day
    Interventions:
    • Drug: Colchicine
    • Drug: Febuxostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2014)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02060552
Other Study ID Numbers  ICMJE Diagout1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yikai Yu, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shaoxian HU, Doctor Tongji Hospital
PRS Account Tongji Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP