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

NCT03002974 | Completed Phase 2 Results

• 1 other identifier: Sobi.ANAKIN-401
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 37

Brief 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

Keywords

Gout; Interleukin 1 receptor antagonist; IL-1 receptor antagonist

Outcome Measures

Primary Outcomes (1)

• 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

  Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100). Average of the assessments performed at 24, 48 and 72 hours.

  At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study

Secondary Outcomes (21)

• 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

  At baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8 for the first gout flare treated in the study

• Median Time to Onset of Effect

  From baseline (predose) up to Day15 of the first flare treated in the study

• Median Time to Response

  From baseline (predose) up to Day15 of the first flare treated in the study

• Median Time to Resolution of Pain

  From baseline (predose) up to Day15 of the first flare

• Median Time to First Intake of Rescue Medication From First Investigational Drug Administration

  From Day 1 to Day 15 for the first flare treated

Study Arms (3)

Anakinra 100 mg

EXPERIMENTAL

1 subcutaneous injection of Anakinra 100 mg once daily for 5 days, 1 subcutaneous injection of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg

Drug: Anakinra 100 mg; Drug: Placebo to Anakinra 100 mg; Drug: Placebo to Triamcinolone Acetonide 40 mg

Anakinra 200 mg

EXPERIMENTAL

2 subcutaneous injections of Anakinra 100 mg (2 syringes) once daily for 5 days and 1 single intramuscular injection of Placebo to Triamcinolone Acetonide 40 mg

Drug: Anakinra 100 mg; Drug: Placebo to Triamcinolone Acetonide 40 mg

Triamcinolone 40 mg

ACTIVE COMPARATOR

2 subcutaneous injections of Placebo to Anakinra 100 mg once daily for 5 days and 1 single intramuscular injection of Triamcinolone Acetonide 40 mg

Drug: Triamcinolone Acetonide 40 mg; Drug: Placebo to Anakinra 100 mg

Interventions

Anakinra 100 mg DRUG

100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection

Also known as: Kineret

Anakinra 100 mg; Anakinra 200 mg

Triamcinolone Acetonide 40 mg DRUG

1 mL intramuscular injection of a 40 mg/mL injectable suspension

Also known as: Kenalog, Triamcinolone

Triamcinolone 40 mg

Placebo to Anakinra 100 mg DRUG

sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe

Also known as: Placebo Kineret

Anakinra 100 mg; Triamcinolone 40 mg

Placebo to Triamcinolone Acetonide 40 mg DRUG

1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension

Also known as: Placebo Kenalog

Anakinra 100 mg; Anakinra 200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Current flare of gouty arthritis characterized by pain intensity
• Currently tender and swollen joint
• Women of childbearing potential willing to use adequate contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead

Study Sites (37)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Fundamental Research, LLC

Gulf Shores, Alabama, 36542, United States

Location

Coastal Clinical Research, Inc

Mobile, Alabama, 36608, United States

Location

Advanced Research Center

Anaheim, California, 92805, United States

Location

Delta Waves Sleep Disorder and Research Center

Colorado Springs, Colorado, 80918, United States

Location

Pulmonary Associates of Brandon

Brandon, Florida, 33511, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Health Awareness

Jupiter, Florida, 33458, United States

Location

Well Pharma Medical Research

Miami, Florida, 33143, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

Clinical Research Trials of Florida

Tampa, Florida, 33607, United States

Location

Meridien Research, Inc

Tampa, Florida, 33634, United States

Location

Kaushik Amin MD

Conyers, Georgia, 30013, United States

Location

Alta Pharmaceutical Research Center

Dunwoody, Georgia, 30338, United States

Location

Lemah Creek Clinical Research

Melrose Park, Illinois, 60160, United States

Location

The Research Group of Lexington

Lexington, Kentucky, 40503, United States

Location

Clinical Trials Management

Metairie, Louisiana, 70006, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5422, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Boiling Springs Medical Research, Inc.

Shelby, North Carolina, 28150, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Hightop Medical Research Center

Cincinnati, Ohio, 45224, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Clinical Research Solutions - Franklin

Franklin, Tennessee, 37067, United States

Location

Clinical Research Solutions

Smyrna, Tennessee, 37167, United States

Location

Renaissance Clinical Research and Hypertension Clinic of Texas, PLLC

Dallas, Texas, 75234, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States

Location

Accurate Clinical Management

Pasadena, Texas, 77505, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Wade Family Medicine

Bountiful, Utah, 84010, United States

Location

Ericksen Research & Development

Clinton, Utah, 84015, United States

Location

Advanced Clinical Research - West Jordan

West Jordan, Utah, 84088, United States

Location

Commonwealth Clinical Research Specialists, Inc.

Richmond, Virginia, 23235, United States

Location

Corporation Lane Internal Medicine and Research Center

Virginia Beach, Virginia, 23462, United States

Location

Mileground Physicians, PLLC

Morgantown, West Virginia, 26505, United States

Location

Clinical Investigations Specialists, Inc.

Kenosha, Wisconsin, 53142, United States

Location

Related Publications (1)

• Saag KG, Khanna PP, Keenan RT, Ohlman S, Osterling Koskinen L, Sparve E, Akerblad AC, Wiken M, So A, Pillinger MH, Terkeltaub R. A Randomized, Phase II Study Evaluating the Efficacy and Safety of Anakinra in the Treatment of Gout Flares. Arthritis Rheumatol. 2021 Aug;73(8):1533-1542. doi: 10.1002/art.41699. Epub 2021 Jul 7.

  PMID: 33605029 DERIVED

MeSH Terms

Conditions

Gout

Interventions

Interleukin 1 Receptor Antagonist Protein; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Kineret Clinical Program Leader
• Organization: Swedish Orphan Biovitrum

info@sobi.com

+46(8)6972000

Study Officials

• Sven Ohlman, MD, PhD

  Swedish Orphan Biovitrum AB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 26, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2019
• Last Updated: July 15, 2020
• Results First Posted: July 15, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (37)