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Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

Information source: Savient Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gout

Intervention: placebo (Other); pegloticase (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Savient Pharmaceuticals

Official(s) and/or principal investigator(s):
Medical Director, MD, Study Director, Affiliation: Savient Pharmaceuticals, Inc.

Summary

These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies, or for whom those therapies have been unsuccessful in controlling their uric acid level.

Clinical Details

Official title: Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Plasma Uric Acid (PUA) Responder

Secondary outcome:

Reduction in Tophus Burden

Percentage of Subjects With Gout Flare Per 3-month Period

Change in Number of Swollen Joints

Change in Number of Tender Joints

Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life

Detailed description: The primary objective of each of the studies is to demonstrate superiority in the response rate (control of uric acid levels to below 6 mg/dL) in the PEG-uricase treatment groups compared to the placebo-control group. While reduction or resolution of tophi have been reported in the setting of prolonged urate-lowering therapy, there is photographic and additional anecdotal evidence from the Phase 2 PEG-uricase study of resolution or significant reduction of tophi after 3 months of therapy. Therefore, an assessment of changes in tophi over time will be conducted through the use of digital photographs obtained in a standardized manner from all subjects during the study. The effect on other clinical outcomes, including quality of life, health-related disability measures, gout flares and the number of swollen and tender joints will also be compared between the treatment groups and control group. Subjects will be randomized to one of the three treatment arms in a 2: 2:1 ratio: 8 mg PEG-uricase every 2 weeks; 8 mg PEG-uricase every 4 weeks; or placebo. All subjects will receive an intravenous infusion (PEG-uricase or placebo) every two weeks in order to maintain the blind throughout the study. Study duration is approximately 26 weeks, including two weeks for screening and 24 weeks (6 months) of treatment.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Outpatients of either gender, age 18 or older ( no upper age limit). 2. Patient is hyperuricemic: screening serum uric acid must be ≥8 mg/dL. 3. Patient has symptomatic gout (presence of at least 3 gout flares in the 18 months prior to entry, or at least one gout tophus, or gouty arthritis). 4. Conventional therapy is contraindicated or has been ineffective in this patient, i. e., patient has a history (either by medical record or patient interview) of hypersensitivity or of failure to normalize SUA with at least 3 months treatment with allopurinol at the maximum labeled dose (800 mg/dL in the U. S.), or at a medically appropriate lower dose based on dose-limiting toxicity or dose-limiting co-morbidity. 5. Patient is willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed, including washout). 6. If the patient is a woman of childbearing potential, she must have had a negative screening serum pregnancy test and must use a medically approved form of birth control during her participation in the protocol. Such methods include oral, injectable or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide. (If male or surgically sterile, check N/A.) Exclusion Criteria: 1. The patient has unstable angina. 2. The patient has uncontrolled arrhythmia. 3. The patient has non-compensated congestive heart failure. 4. The patient has uncontrolled hypertension (above 150/95). 5. The patient has a history of end stage renal disease requiring dialysis. 6. The patient has hemoglobin < 8 g/dL (males) or < 7 g/dL (females). 7. The patient is an organ transplant recipient 8. The patient has had prior treatment with PEG-uricase, or other recombinant uricase, or any concomitant therapy with a PEG-conjugated drug. 9. The patient has had a gout flare at screening that is resolved for less than one week prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis). 10. The patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency. 11. The patient has a history of anaphylactic reaction to a recombinant protein or porcine product, or hypersensitivity to PEG. 12. The patient is pregnant or breast feeding. 13. The patient has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study. 14. The patient has a known allergy to urate oxidase or PEGylated products. 15. The patient has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Locations and Contacts

UAB Arthritis Clinical Intervention Program, Birmingham, Alabama 35294, United States

University of Arizona Arthritis Center, Tucson, Arizona 85724, United States

NEA Clinic, Jonesboro, Arkansas 72401, United States

UCSD Rheumatology Division, La Jolla, California 92037-0943, United States

Kaiser Permanente Medical Center, Clinical Trials Unit, San Francisco, California 94118, United States

Pacific Arthritis Center Medical Group, Santa Maria, California 93454, United States

Agilence Arthritis & Osteoporosis Medical Center, Whittier, California 90606, United States

E. Robert Harris Medical Corporation, Whittier, California 90601, United States

Arthritis Associates & Osteoporosis Center of Colorado Springs, Colorado Springs, Colorado 80910, United States

Clinica para el Diagnostico y Tratamiento de las Enfermedades Rheumaticas, Mexico, D.f., Mexico

Hospital General de mexico, Mexico, D.f., Mexico

Veterans Affairs Medical Center, Washington, District of Columbia 20422, United States

Arthritis & Rheumatic Disease Specialties, Aventura, Florida 33180, United States

Malcom Randall VA Medical Center, Gainesville, Florida 32608, United States

Horizon Institute for Clinical Research, Hollywood, Florida 33021, United States

Ocala Rheumatology Research Center, Ocala, Florida 34474, United States

Arthritis & Osteoporosis Treatment Center, PA, Orange Park, Florida 32073, United States

St. Petersburg Arthritis Center, St. Petersburg, Florida 33703, United States

Idaho Arthritis & Osteoporosis Center, Boise, Idaho 83702, United States

Institute of Arthritis Research, Idaho Falls, Idaho 83401, United States

The University of Chicago, Chicago, Illinois 60637, United States

Antiguo Hospital Civil de Guadalajara, Guadalajara, Jalisco, Mexico

Hospital Civil de Guadalajara, Guadalajara, Jalisco, Mexico

Graves Gilbert Clinic, Bowling Green, Kentucky 42101, United States

Manitoba Clinic, Winnipeg, Manitoba R3A 1M3, Canada

Peter A. Holt, M.D., Baltimore, Maryland 21239, United States

Malamet & Klein, MD, PA, Hagerstown, Maryland 21740, United States

The Center for Rheumatology and Bone Research, Wheaton, Maryland 20902, United States

Fallon Clinic, Inc, Worcester, Massachusetts 01605, United States

Michigan Arthritis Research Center, Brighton, Michigan 48116, United States

Justus J. Fiechtner, MD, PC, Lansing, Michigan 48910, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

CentraCare Clinic, St. Cloud, Minnesota 56377, United States

Rheumatology Associates of North Jersey, Teaneck, New Jersey 07666, United States

Mount Sinai Medical Center, New York, New York 10029-6574, United States

Duke University Medical Center, Durham, North Carolina 27302, United States

Brody School of Medicine, East Carolina University, Greenville, North Carolina 27834, United States

Physicians East, P.A., Greenville, North Carolina 27834, United States

Carolina Atthritis Associates, Wilmington, North Carolina 28401, United States

New Horizons Clinical Research, Cincinnati, Ohio 45242, United States

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

The Ohio State University, Columbus, Ohio 43210, United States

STAT Research, Inc., Dayton, Ohio 45402, United States

David R. Mandel, MD, Inc., Mayfield Village, Ohio 44143, United States

Health Research of Oklahoma, Oklahoma City, Oklahoma 73139, United States

St. Joseph's Health Care, London, Ontario N6A 4V2, Canada

Portland Medical Associates, Portland, Oregon 97224, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Mid Atlantic Research Assoc., Philadelphia, Pennsylvania 19154, United States

Rheumatology Associates, Charleston, South Carolina 29407, United States

Piedmont Arthritis, PA, Greenville, South Carolina 29601, United States

AAMR Research Clinic, Amarillo, Texas 79106, United States

Arthritis & Osteoporosis Center of South Texas, San Antonio, Texas 78232, United States

Arthritis & Osteoporosis Clinic Research Center of Central Texas, Waco, Texas 76708, United States

Arthritis Northwest, PLLC, Spokane, Washington 99204, United States

Rheumatic Disease Center, Glendale, Wisconsin 53217, United States

Additional Information

For information on the study, enrollment screener, gout, in general

Starting date: May 2006
Last updated: February 24, 2011

Page last updated: August 23, 2015

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