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

NCT03002974 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2020-07-15

Study results available
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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.

Conditions

  • Acute Gouty Arthritis

Interventions

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

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Sven Ohlman, MD, PhD · Swedish Orphan Biovitrum AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-06-30
Completion
2019-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002974 on ClinicalTrials.gov