Refractory Chronic Gout Clinical Trial
— EyesOnGOUTOfficial title:
Observational Study of the Use of KRYSTEXXA® (Pegloticase) in Adult Hyperuricemic Patients With Gout Refractory to Conventional Therapy
| NCT number | NCT01466166 |
| Other study ID # | M0401 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 15, 2011 |
| Est. completion date | June 30, 2017 |
| Verified date | June 2018 |
| Source | Horizon Pharma Rheumatology LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. Additionally, serious adverse events associated with pegloticase therapy will be identified.
| Status | Completed |
| Enrollment | 188 |
| Est. completion date | June 30, 2017 |
| Est. primary completion date | June 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adults (age 18 years or more) with chronic gout refractory to conventional therapy, defined as patients who have failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated. - Patients who have made the decision, along with their treating physician, to begin treatment with KRYSTEXXA. - Patients who are willing and able to give informed consent and adhere to visit/protocol schedules. Exclusion Criteria: - Glucose-6-phosphate dehydrogenase (G6PD) deficiency - Non-compensated congestive heart failure - Pregnancy or breast feeding - Prior treatment with pegloticase or another recombinant uricase - Known allergy to urate oxidase - Prior treatment or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug - Recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study |
| Country | Name | City | State |
|---|---|---|---|
| United States | Keystone Pain Institute, Ilumina Clinical Associates | Altoona | Pennsylvania |
| United States | University of Michigan Health System | Ann Arbor | Michigan |
| United States | Arthritis Clinic of Northern Virginia, P.C. | Arlington | Virginia |
| United States | Austin Regional Clinic | Austin | Texas |
| United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
| United States | Rheumatology Associates, PC | Birmingham | Alabama |
| United States | UAB Rheumatology | Birmingham | Alabama |
| United States | Bay Area Arthritis and Osteoporosis | Brandon | Florida |
| United States | Global Research Partners & Consultants, Inc. | Calhoun | Georgia |
| United States | Caro Health Plaza | Caro | Michigan |
| United States | Physicians' Clinic of Iowa, P.C. | Cedar Rapids | Iowa |
| United States | Low Country Rheumatology | Charleston | South Carolina |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | Mountain State Clinical Research | Clarksburg | West Virginia |
| United States | Countryside Arthritis Center | Clearwater | Florida |
| United States | NorthEast Rheumatology | Concord | North Carolina |
| United States | Medvin Clinical Research | Covina | California |
| United States | Denver Nephrologists, PC | Denver | Colorado |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Saint Paul Rheumatology, PA | Eagan | Minnesota |
| United States | Dr. Raj Marwah | El Paso | Texas |
| United States | Horizon Research Group of Opelousas, LLC | Eunice | Louisiana |
| United States | Rheumatic Disease Center, LLP | Glendale | Wisconsin |
| United States | Infusion Associates | Grand Rapids | Michigan |
| United States | Physicians East, PA | Greenville | North Carolina |
| United States | Klein & Associates MD, PA. | Hagerstown | Maryland |
| United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Diagnostic Clinic of Houston | Houston | Texas |
| United States | Rheumatic Disease Clinical Research Center | Houston | Texas |
| United States | Saadat Ansari, MD, LLC | Huntsville | Alabama |
| United States | Diagnostic Rheumatology and Research PC | Indianapolis | Indiana |
| United States | Science and Research Institute, Inc | Jupiter | Florida |
| United States | Kansas City Internal Medicine | Kansas City | Missouri |
| United States | Apex Clinical Research | Kennewick | Washington |
| United States | Alliance Clinical Research, LLC | Laguna Hills | California |
| United States | Advanced Medical Research, LLC | Lakewood | California |
| United States | Justus J. Fiechtner, MD, PC | Lansing | Michigan |
| United States | Arthritis Medical Clinic | Las Vegas | Nevada |
| United States | Pacific Arthritis Care Center | Los Angeles | California |
| United States | Arthritis & Osteoporosis Center of North Virginia | Manassas | Virginia |
| United States | Ramesh C. Gupta, M.D. | Memphis | Tennessee |
| United States | A & O Research Center | Miami | Florida |
| United States | Arthritis and Diabetes Clinic, Inc. | Monroe | Louisiana |
| United States | R Srinivasan, MD, Inc | Monterey Park | California |
| United States | Central Kentucky Research Associates of Kentucky | Mount Sterling | Kentucky |
| United States | Brigid Freyne, MD, Inc | Murrieta | California |
| United States | Sentara Rheumatology Specialists | Norfolk | Virginia |
| United States | Acme Research L.L.C. | Orangeburg | South Carolina |
| United States | Research Integrity, LLC | Owensboro | Kentucky |
| United States | Arthritis Research of Florida, Inc. | Palm Harbor | Florida |
| United States | Family Clinical Trials, LLC | Pembroke Pines | Florida |
| United States | Southern Ohio Rheumatology | Portsmouth | Ohio |
| United States | Alliance Clinical Research | Poway | California |
| United States | Shanahan Rheumatology and Immunotherapy, PLLC | Raleigh | North Carolina |
| United States | Shores Rheumatology, PC | Saint Clair Shores | Michigan |
| United States | Specialty Medical Clinic and Research Center | Sanford | North Carolina |
| United States | Rheumatology Associates of Long Island | Smithtown | New York |
| United States | Arthritis Research & Treatment Center | Stockbridge | Georgia |
| United States | Jedidiah Clinical Research | Tampa | Florida |
| United States | Midtown Medical Center | Tampa | Florida |
| United States | Rheumatology Associates of North Jersey | Teaneck | New Jersey |
| United States | New England Research Associates, LLC | Trumbull | Connecticut |
| United States | Howard University Hospital | Washington | District of Columbia |
| United States | Washington DC Veteran's Affairs Medical Center | Washington | District of Columbia |
| United States | The Center for Rheumatology and Bone Research | Wheaton | Maryland |
| United States | Clinical Pharmacology Study Groups | Worcester | Massachusetts |
| United States | Reliant Medical Group, Inc. | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Horizon Pharma Rheumatology LLC |
United States,
Sundy JS, Baraf HS, Yood RA, Edwards NL, Gutierrez-Urena SR, Treadwell EL, Vázquez-Mellado J, White WB, Lipsky PE, Horowitz Z, Huang W, Maroli AN, Waltrip RW 2nd, Hamburger SA, Becker MA. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011 Aug 17;306(7):711-20. doi: 10.1001/jama.2011.1169. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Infusion Reactions | Infusion reactions were defined as adverse events (AEs) or clusters of events, not attributable to another cause that occurred during or within 2 hours after the infusion of pegloticase. Any other case that occurred outside of the 2-hour window was categorized per Investigator discretion. | 52 weeks | |
| Primary | Number of Participants With Anaphylaxis | Anaphylaxis was defined using the National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network (NIAID/FAAN) criteria: Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives; pruritus or flushing; swollen lips, tongue, or uvula), and at least 1 of the following: Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia). Reduced blood pressure (i.e., systolic blood pressure < 90 mm Hg or greater than 30% decrease from that patient's baseline) or associated symptoms of end-organ failure (e.g., hypotonia [collapse], syncope, incontinence). |
52 weeks | |
| Primary | Number of Participants With Immune Complex-related Events | Immune complex-related events were defined as any presumptive immune complex-related disorders that were confirmed by an appropriate investigation of the event and of complement markers (C3 and C4 levels). Clinical manifestations could have included skin rash, arthralgia, arthritis, proteinuria, serum sickness, and cryoglobulinemia. | From first dose of study drug to the end of the 12-week follow-up period (63 weeks). | |
| Secondary | Percentage of Participants With Normalization of Serum Uric Acid at Week 24 and Week 52 | Normalization of serum uric acid was defined as serum uric acid value less than 6 mg/dL. | Week 24 and week 52 | |
| Secondary | Change From Baseline in Number of Gout Flares | The number of gout flares occurring in the 2 weeks prior to each visit. Baseline number of flares was calculated as the average number of flares that occurred in the 6-month baseline period divided by 12 weeks. | Baseline, week 24 and week 48 | |
| Secondary | Number of Swollen Joints Over Time | Baseline and weeks 24 and 52 | ||
| Secondary | Number of Tender Joints Over Time | Baseline and weeks 24 and 52 | ||
| Secondary | Number of Palpable Tophi Over Time | Gout tophi are nodular deposits of urate crystals and inflammatory cells in joints, soft tissues, bones, and in some organs. | Baseline and weeks 24 and 52 |