A Clinical Trial to Study the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000832

Enrollment

Registered

2009-10-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Rilonacept: 160 mg and 80mg s.c. Intervention2: Matching Placebo: Matching Control Intervention1: Allopurinol: 100 mg and 300 mg tablets

Eligibility

Inclusion criteria

Inclusion criteria: Male or female 18 to 80 years of age Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout At least 2 gout flares in the year prior to the Screening Visit Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit

Exclusion criteria

Exclusion criteria: Acute gout flare within 2 weeks of the Screening Visit or during Screening Persistent chronic or active infections History of an allergic reaction to allopurinol History or presence of cancer within 5 years of the Screening Visit Previous exposure to rilonacept Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the Screening Visit

Design outcomes

Primary

Measure	Time frame
The number of gout flares per subject assessed from Day 1 to Week 16.Timepoint: number of gout flares	—

Secondary

Measure	Time frame
The number of gout flares per subject from Day 1 to Week 16. The proportion of subjects with at least one flare from Day 1 to Week 16 The proportion of subjects with at least two flares from Day 1 to Week 16 The mean number of gout flare days per subject assessed from Day 1 to Week 16 The mean number of days with the subjects pain score of 5 or more (daily diary) per subject from Day 1 to Week 16Timepoint: number of days with the subjects pain score of 5 or more	—

Measure

Time frame

The number of gout flares per subject from Day 1 to Week 16. The proportion of subjects with at least one flare from Day 1 to Week 16 The proportion of subjects with at least two flares from Day 1 to Week 16 The mean number of gout flare days per subject assessed from Day 1 to Week 16 The mean number of days with the subjects pain score of 5 or more (daily diary) per subject from Day 1 to Week 16Timepoint: number of days with the subjects pain score of 5 or more

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Countries

India, Indonesia

Contacts

Public ContactSuneela Thatte

Director Regulatory Affairs

sanghamitra.patnaik@quintiles.com+91-79-6630 3340

Outcome results