NCT02060552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

February 8, 2014

Last Update Submit

May 7, 2014

Conditions

Primary Gout

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 weeks

  • 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

    24 weeks

Secondary Outcomes (5)

  • Serum and urine urate concentration

    24 weeks

  • HAQ

    12 weeks

  • Flow Cytometry analysis on cell markers

    12 weeks

  • Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC

    12 weeks

  • Serum concentration of inflammatory cytokines

    12 weeks

Study Arms (3)

Febuxostat

PLACEBO COMPARATOR

Febuxostat 40mg once a day

Drug: Febuxostat

Febuxostat plus diacerein

EXPERIMENTAL

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

Drug: DiacereinDrug: Febuxostat

Febuxostat plus Colchicine

EXPERIMENTAL

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

Drug: ColchicineDrug: Febuxostat

Interventions

DiacereinDRUG

oral administration of IL-1βinhibitory

Also known as: Diacetylrhein
Febuxostat plus diacerein
ColchicineDRUG

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

Also known as: Colcrys, Generics
Febuxostat plus Colchicine
FebuxostatDRUG

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

Also known as: No other names
FebuxostatFebuxostat plus ColchicineFebuxostat plus diacerein

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yikai YU

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

diacereinColchicineFebuxostat

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Shaoxian HU, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 8, 2014

First Posted

February 12, 2014

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

CN(1)