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Completed

NCT Number: NCT02060552

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

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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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yikai YU

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diacerein

Drug

oral administration of IL-1βinhibitory

Other names: Diacetylrhein

Colchicine

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

Other names: Colcrys, Generics

Febuxostat

Drug

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

Other names: No other names

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2014
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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