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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

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.

Condition or disease Intervention/treatment Phase
Primary Gout Drug: Diacerein Drug: Colchicine Drug: Febuxostat Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diacerein Combined With Febuxostat Relieves Symptoms of Gout by Suppressing IL-1βinflammation
Study Start Date : January 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Placebo Comparator: Febuxostat
Febuxostat 40mg once a day
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

Experimental: Febuxostat plus diacerein
Febuxostat 40mg once a day plus diacerein 50mg twice a day
Drug: Diacerein
oral administration of IL-1βinhibitory
Other Name: Diacetylrhein

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

Experimental: Febuxostat plus Colchicine
Febuxostat 40mg once a day plus Colchicine 0.5mg twice a day
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




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Serum and urine urate concentration [ Time Frame: 24 weeks ]
    serum urate concentration and 24h urine urate concentration

  2. 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

  3. 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

  4. Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC [ Time Frame: 12 weeks ]
    IL-1β,IL-18, IL-10

  5. Serum concentration of inflammatory cytokines [ Time Frame: 12 weeks ]
    IL-1β,IL-10,IL-6 and IL-8 etc.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060552


Locations
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China, Hubei
Yikai YU
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Tongji Hospital
Investigators
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Principal Investigator: Shaoxian HU, Doctor Tongji Hospital

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Responsible Party: Yikai Yu, Doctor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02060552     History of Changes
Other Study ID Numbers: Diagout1
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Gout
Gout Suppressants
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Diacetylrhein
Colchicine
Febuxostat
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Inflammatory Agents