Phase 2
N=165
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis
Acute Gouty Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03002974 ↗Enrolled (actual)
165
Serious AEs
3.1%
Results posted
Jul 2020
Primary outcome: Primary: Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS — -26.1; -32.5; -31.1; -43.4 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anakinra 100 mg (Drug); Triamcinolone Acetonide 40 mg (Drug); Placebo to Anakinra 100 mg (Drug); Placebo to Triamcinolone Acetonide 40 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Swedish Orphan Biovitrum
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS |
-26.1; -32.5; -31.1; -43.4; -42.9; -43.6 | — |
| SECONDARY Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale |
-0.6; -0.8; -0.4; -0.9; -1.1; -0.5 | — |
| SECONDARY Median Time to Onset of Effect |
22.3; 11.8; 19.8 | — |
| SECONDARY Median Time to Response |
47.6; 43.0; 46.9 | — |
| SECONDARY Median Time to Resolution of Pain |
167.5; 131.8; 119.8 | — |
| SECONDARY Median Time to First Intake of Rescue Medication From First Investigational Drug Administration |
NA; NA; NA | — |
| SECONDARY Physician's Assessment of Global Response to Treatment |
1.54; 1.25; 1.25; 1.26; 0.90; 0.81 | — |
| SECONDARY Physician's Assessment of Clinical Signs in Index Joint: Tenderness |
8; 18; 16; 22; 28; 25 | — |
| SECONDARY Physician's Assessment of Clinical Signs in Index Joint: Swelling |
0; 0; 0; 9; 14; 7 | — |
| SECONDARY Physician's Assessment of Clinical Signs in Index Joint: Erythema |
3; 8; 8; 51; 48; 45 | — |
| SECONDARY Patient´s Assessment of Global Response to Treatment (5-point Likert Scale) |
11; 10; 18; 13; 19; 9 | — |
| SECONDARY Change From Baseline in the Inflammatory Biomarker C Reactive Protein |
-0.362; -1.435; -1.362; -0.321; -1.334; 1.406 | — |
| SECONDARY Change From Baseline in the Inflammatory Biomarker Serum Amyloid A |
8.950; -45.160; -34.510; -6.363; -46.561; -35.887 | — |
| SECONDARY The Percent of Patients With at Least One Adverse Event |
40.7; 38.2; 55.8 | — |
| SECONDARY The Percent of Patients With at Least One Serious Adverse Event, Including Death |
0; 7.3; 0 | — |
| SECONDARY Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra |
2.032; 4.883; 1.950; 1.974; 267.744; 628.053 | — |
| SECONDARY Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra |
2; 5; 2; 1; 4; 3 | — |
| SECONDARY Proportion of Patients With Neutralizing Antibodies |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score |
8.0; 10.5; 10.4; 11.8; 12.2; 9.4 | — |
| SECONDARY Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) |
2; 1; 0; 5; 6; 5 | — |
| SECONDARY Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares |
36.1; 32.6; 20.5; 23.3; 12.6; 21.6 | — |
| SECONDARY Health Care Resource Utilization Due to a Gouty Arthritis Flare |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Signed Informed consent
- Patient meeting the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2015 gout classification criteria
- History of ≥1 self-reported flares of gouty arthritis within 12 months
- Current ongoing flare of gouty arthritis characterized by pain intensity
- Currently tender and swollen joint
- Onset of current flare within 4 days
- Intolerant, unresponsive, contraindicated or not appropriate for treatment with NSAIDs and colchicine (both treatment options)
- If on urate-lowering therapy, on a stable dose and regimen
- Women of childbearing potential willing to use adequate contraception
Inclusion criteria for treatment of subsequent flare(s)
- Current flare of gouty arthritis characterized by pain intensity
- Currently tender and swollen joint
- Women of childbearing potential willing to use adequate contraception
Exclusion Criteria
- Use of specified pain relief medications or biologics (including glucocorticoids, narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor inhibitors) within specified periods prior to randomization
- Contraindication to triamcinolone
- Polyarticular gouty arthritis involving more than 4 joints
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
- History of malignancy within the past 5 years. Exceptions are basal cell skin cancer, carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy.
- Known hypersensitivity to Escherichia coli-derived proteins, Kineret® (anakinra), Kenalog® (triamcinolone acetonide) or any components of the products.
- Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B or C infection
- Presence of severe renal function impairment chronic kidney disease (CKD) stages 4 and 5
- Presence of neutropenia
- Uncontrolled clinically significant hematologic, pulmonary, endocrine, metabolic, gastrointestinal, central nervous system or hepatic disease
- History of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting, New York Heart Association (NYHA) class III or IV heart failure within the previous 3 months
- Patients who have undergone major surgery within 2 weeks, or have an unhealed operation wound/s
- Presence of any medical or psychological condition or laboratory result that in the opinion of the investigator might create risk to the patients or to the study.
- Earlier or current treatment with anakinra
- Pregnant or lactating women
- History of >12 flares overall in the 6 months prior to randomization
Exclusion criteria for treatment of subsequent flare(s):
- Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B or C infection.
- Presence of severe renal function impairment CKD stages 4 and 5
- Presence of neutropenia
- History of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting, NYHA class III or IV heart failure within the previous 3 months
- Patients who have undergone major surgery within 2 weeks or have an unhealed operation wound/s.
- Pregnant or lactating women.
- Presence of any condition or laboratory result that in the opinion of the investigator makes the patient not appropriate for treatment
Data sourced from ClinicalTrials.gov (NCT03002974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.