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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Febuxostat

Febuxostat 40mg once a day

Group Type PLACEBO_COMPARATOR

Febuxostat

Intervention Type DRUG

A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout

Febuxostat plus diacerein

Febuxostat 40mg once a day plus diacerein 50mg twice a day

Group Type EXPERIMENTAL

Diacerein

Intervention Type DRUG

oral administration of IL-1βinhibitory

Febuxostat

Intervention Type DRUG

A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout

Febuxostat plus Colchicine

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

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

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

Intervention Type DRUG

A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout

Interventions

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Diacerein

oral administration of IL-1βinhibitory

Intervention Type 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

Intervention Type DRUG

Febuxostat

A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout

Intervention Type DRUG

Other Intervention Names

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Diacetylrhein Colcrys Generics No other names

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes