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Clinical Trial Summary

The purpose of this study is to evaluate how anakinra relieves pain for patients with acute gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The patients will be divided in different treatment groups to compare anakinra to the available drug triamcinolone.

Clinical Trial Description

Patients will be randomized to treatment at their first gout flare in the study. The first treatment period will be followed by an extension period during which the patients will receive the same treatment for any subsequent flares within 52 weeks of randomization of last patient in the study. The extension period for the individual patient in the study will be maximum two years (104 weeks). Each new flare treated will initiate a new series of study visits and assessments according to specified schedule of events. Only if a patient experience a new flare after Day 15 of the latest flare they can start a new treatment period. The comparison of primary interest is between anakinra (100 mg and 200 mg combined) and 40 mg triamcinolone, and as a secondary objective the 2 different doses of anakinra will be evaluated as well as assessment for subsequent flares. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03002974
Study type Interventional
Source Swedish Orphan Biovitrum
Status Completed
Phase Phase 2
Start date December 2016
Completion date August 2019

See also
  Status Clinical Trial Phase
Withdrawn NCT01593527 - Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease Phase 3
Recruiting NCT02545777 - The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid Phase 2
Completed NCT01356602 - Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients Phase 3
Completed NCT00170781 - Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout Phase 4
Completed NCT01431638 - Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients Phase 3