Allopurinol Outcome Study (LASSO)

Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)

This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: Allopurinol

• Study Type: Interventional
• Enrollment (Actual): 1735
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Malvern East, Australia, VIC3145
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
    • Wollongong, New South Wales, Australia, 2522
  • Queensland
    • Birsbane, Queensland, Australia, 4152
  • South Australia
    • Daw Park, South Australia, Australia, 5041
    • Woodville South, South Australia, Australia, 5011
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
  • Victoria
    • Clayton, Victoria, Australia, 3168
    • Heidelberg, Victoria, Australia, 3081
    • North Ballarat, Victoria, Australia, 3353
  • Western Australia
    • Perth, Western Australia, Australia, 6000
• Belgium
  • Bruxelles, Belgium, 1070
  • Gozee, Belgium, 6534
  • Kortrijk, Belgium, 8500
  • Mouscron, Belgium, 7700
  • Yvoir, Belgium, 5530
• Canada
  • Quebec, Canada, G1V 3M7
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3P4
    • Kelowna, British Columbia, Canada, V1Y 3G8
    • Penticton, British Columbia, Canada, V2A 5C8
  • Ontario
    • Ottawa, Ontario, Canada, K1S 1L2
    • Thornhill, Ontario, Canada, L4J 1W3
    • Toronto, Ontario, Canada, M9W 4L6
• Germany
  • Altenburg, Germany, 04600
  • Dresden, Germany, 01307
  • Eichstatt, Germany, 85072
• New Zealand
  • Auckland, New Zealand, 1010
  • Hamilton, New Zealand, 3240
  • Papatoetoe, New Zealand, 2525
  • Rotorua, New Zealand, 3010
  • Tauranga, New Zealand, 3110
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8024
• South Africa
  • Bloemfontein, South Africa, 9301
  • Durban, South Africa, 4092
  • Durban, South Africa, 4037
  • Durban, South Africa, 4067
  • East London, South Africa, 5201
  • Johannesburg, South Africa, 2113
  • Johannesburg, South Africa, 1724
  • Paarl, South Africa, 7646
  • Pretoria, South Africa, 0084
  • Pretoria, South Africa, 2000
  • Rondebosch, South Africa, 7700
  • Stellenbosch, South Africa, 7600
  • Thabazimbi, South Africa, 0380
  • Worcester, South Africa, 6850
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
    • Birmingham, Alabama, United States, 35294
    • Bringham, Alabama, United States, 35216
    • Calera, Alabama, United States, 35040
    • Huntsville, Alabama, United States, 35801
    • Mobile, Alabama, United States, 36608
  • Arizona
    • Chandlers, Arizona, United States, 85224
    • Green Valley, Arizona, United States, 85614
    • Jonesboro, Arizona, United States, 72401
    • Phoenix, Arizona, United States, 85050
    • Phoenix, Arizona, United States, 85028
    • Tucson, Arizona, United States, 85704
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
    • Little Rock, Arkansas, United States, 72204
  • California
    • Anaheim, California, United States, 92805
    • Carmichael, California, United States, 95608
    • Covina, California, United States, 91723
    • Hemet, California, United States, 92543
    • Irvine, California, United States, 92618
    • Los Angeles, California, United States, 90048
    • Mission Viejo, California, United States, 92691
    • Pasadena, California, United States, 91107
    • Sacramento, California, United States, 95816
    • San Diego, California, United States, 92108
    • San Ramon, California, United States, 94583
    • Santa Maria, California, United States, 93454
    • Weslake Village, California, United States, 91361
  • Colorado
    • Denver, Colorado, United States, 80220
    • Englewood, Colorado, United States, 80113
  • Connecticut
    • Danbury, Connecticut, United States, 06810
    • Trumbull, Connecticut, United States, 06611
  • Florida
    • Brandenton, Florida, United States, 34208
    • Brandon, Florida, United States, 33511
    • Brooksville, Florida, United States, 34601
    • East Brandenton, Florida, United States, 34208
    • Fleming Island, Florida, United States, 32003
    • Jacksonville, Florida, United States, 32205
    • Jacksonville, Florida, United States, 32216
    • Jupiter, Florida, United States, 33458
    • Miami, Florida, United States, 33135
    • Oldsmar, Florida, United States, 34677
    • Orlando, Florida, United States, 32804
    • Ormond Beach, Florida, United States, 32174
    • Plant City, Florida, United States, 33563
    • Port Orange, Florida, United States, 32127
    • Sanford, Florida, United States, 32771
    • St. Petersburg, Florida, United States, 33709
    • Tampa, Florida, United States, 33606
    • Vero Beach, Florida, United States, 32960
    • Winter Haven, Florida, United States, 33880
    • Zephyrhills, Florida, United States, 33542
  • Georgia
    • Atlanta, Georgia, United States, 30308
    • Newnan, Georgia, United States, 30265
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
  • Idaho
    • Meridian, Idaho, United States, 83646
  • Illinois
    • Addison, Illinois, United States, 60101
    • Chicago, Illinois, United States, 60637
    • Chicago, Illinois, United States, 60612
    • Gurnee, Illinois, United States, 60031
  • Indiana
    • Evansville, Indiana, United States, 47713
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
    • Lexington, Kentucky, United States, 40504
    • Louisville, Kentucky, United States, 40213
  • Louisiana
    • Monroe, Louisiana, United States, 71203
  • Maryland
    • Cumberland, Maryland, United States, 21502
    • Frederick, Maryland, United States, 21702
    • Hagerstown, Maryland, United States, 21740
    • Wheaton, Maryland, United States, 20902
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
    • Worcester, Massachusetts, United States, 01605
  • Michigan
    • South Traverse City, Michigan, United States, 49684
  • Minnesota
    • Rochester, Minnesota, United States, 55905
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
  • Missouri
    • Florissant, Missouri, United States, 63031
    • Kansas City, Missouri, United States, 64114
    • Saint Louis, Missouri, United States, 63117
    • St. Louis, Missouri, United States, 63128
  • Nebraska
    • Omaha, Nebraska, United States, 68114
  • Nevada
    • Las Vegas, Nevada, United States, 89119
    • Reno, Nevada, United States, 89502
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
    • Albuquerque, New Mexico, United States, 87106
  • New York
    • Albany, New York, United States, 12206
    • Endwell, New York, United States, 13760
    • Hartsdale, New York, United States, 10530
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
    • Harrisburg, North Carolina, United States, 28075
    • Hickory, North Carolina, United States, 28602
    • Raleigh, North Carolina, United States, 27609
    • Raleigh, North Carolina, United States, 27612
    • Wilmington, North Carolina, United States, 28401
  • North Dakota
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Cincinnati, Ohio, United States, 45242
    • Cincinnati, Ohio, United States, 45224
    • Cleveland, Ohio, United States, 44122
    • Columbus, Ohio, United States, 43203
    • Dayton, Ohio, United States, 45417
    • Middleburg Heights, Ohio, United States, 44130
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
  • Oregon
    • Eugene, Oregon, United States, 97402
    • Portland, Oregon, United States, 97220
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
    • Duncansville, Pennsylvania, United States, 16635
    • Lancaster, Pennsylvania, United States, 17601
  • South Carolina
    • Charleston, South Carolina, United States, 29407
    • Mount Pleasant, South Carolina, United States, 29464
    • Spartanburg, South Carolina, United States, 29303
  • Tennessee
    • Jackson, Tennessee, United States, 38305
    • Spring Hill, Tennessee, United States, 37174
  • Texas
    • Dallas, Texas, United States, 75216
    • Dallas, Texas, United States, 75235
    • Houston, Texas, United States, 77074
    • Houston, Texas, United States, 77088
    • Irving, Texas, United States, 75061
    • Mesquite, Texas, United States, 75150
    • San Antonio, Texas, United States, 78229
    • Sugar Land, Texas, United States, 77479
  • Utah
    • Bountiful, Utah, United States, 84010
    • West Jordan, Utah, United States, 84088
  • Virginia
    • Arlington, Virginia, United States, 22205
    • Richmond, Virginia, United States, 23294
  • Washington
    • Port Orchard, Washington, United States, 98366
    • Seattle, Washington, United States, 98122
    • Spokane, Washington, United States, 99208
    • Tacoma, Washington, United States, 98405
  • West Virginia
    • Morgantown, West Virginia, United States, 26505

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
• Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
• If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
• Must have had at least 2 gout flares in the past year.

Exclusion Criteria:

• Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
• History or suspicion of drug abuse.
• History of autoimmune disease requiring systemic treatment.
• Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
• History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
• Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
• Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).
• Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.
• Kidney or other organ transplant.
• Active peptic ulcer disease requiring treatment.
• History of xanthinuria, active liver disease, or hepatic dysfunction.
• If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
• Known hypersensitivity or allergy to allopurinol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Allopurinol; Treatment.	Drug: Allopurinol; Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Allopurinol	Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.	Every month for 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL	Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6.	Month 6
Incidence of Gout Flares	Proportion of subjects who experienced at least one gout flare requiring treatment during the study.	Every month for 6 months.
Mean Change From Baseline to Month 6 in SF-36 PCS+MCS	The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10.	Month 6

Collaborators and Investigators

• Sponsor: Ardea Biosciences, Inc.
• Investigators: Study Director: S Baumgartner, MD, Ardea Biosciences, Inc.

Publications and helpful links

General Publications

• Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.
• Becker MA, Fitz-Patrick D, Choi HK, Dalbeth N, Storgard C, Cravets M, Baumgartner S. An open-label, 6-month study of allopurinol safety in gout: The LASSO study. Semin Arthritis Rheum. 2015 Oct;45(2):174-83. doi: 10.1016/j.semarthrit.2015.05.005. Epub 2015 May 21.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: May 16, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol
• Other Study ID Numbers: ALLO-401