At a glance
ClinicalIndex Comparison Record- ✓Meets ACR/EULAR 2015 gout classification criteria
- ✓At least 1 self-reported gouty arthritis flare in past 12 months
- ✓Current acute gouty arthritis flare with pain and joint tenderness/swelling, onset within 4 days
- ✓Intolerant, unresponsive, contraindicated, or not appropriate for both NSAIDs and colchicine
- ✕Polyarticular gouty arthritis involving more than 4 joints
- ✕Rheumatoid arthritis, septic arthritis, or other acute inflammatory arthritis
- ✕Active or recurrent bacterial, fungal, or viral infections, including tuberculosis, HIV, hepatitis B or C
- ✕Severe renal impairment (CKD stages 4-5)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Anakinra 100 mg, Triamcinolone Acetonide 40 mg, and 2 other interventions for Acute Gouty Arthritis. Completed, enrolled 165 participants across 37 sites.
Detailed 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.
Study Details
Timeline
Interventions
100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
1 mL intramuscular injection of a 40 mg/mL injectable suspension
sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension