NCT03002974

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Gouty Arthritis

Interventions

Type	Name	Description
DRUG	Anakinra 100 mg	100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
DRUG	Triamcinolone Acetonide 40 mg	1 mL intramuscular injection of a 40 mg/mL injectable suspension
DRUG	Placebo to Anakinra 100 mg	sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
DRUG	Placebo to Triamcinolone Acetonide 40 mg	1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-06-01
• Completion: 2019-08-01
• First posted: 2016-12-26
• Last updated: 2020-07-15
• Results posted: 2020-07-15

Locations

37 sites across 1 country: United States