A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis — anaGO  

Acute Gouty Arthritis Clinical Trial

Official title: A Randomized, Double-blind, Active-control, Multicenter, Efficacy and Safety Study of 2 Dose Levels of Subcutaneous Anakinra Compared to Intramuscular Triamcinolone in the Treatment of Acute Gouty Arthritis, Followed by an Extension Period of up to 2 Years

Status Completed

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. ;

Related Conditions & MeSH terms

• Acute Gouty Arthritis
• Arthritis
• Arthritis, Gouty

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