Observational Study of the Use of KRYSTEXXA® in Refractory Chronic Gout (EyesOnGOUT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Crealta Pharmaceuticals LLC
Sponsor:
Information provided by (Responsible Party):
Crealta Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT01466166
First received: October 28, 2011
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The primary purpose of this study is to observe patients being treated with KRYSTEXXA 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 KRYSTEXXA therapy will be identified.


Condition Intervention
Chronic Gout
Biological: pegloticase

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study of the Use of KRYSTEXXA® (Pegloticase)in Adult Hyperuricemic Patients With Gout Refractory to Conventional Therapy

Resource links provided by NLM:


Further study details as provided by Crealta Pharmaceuticals LLC:

Primary Outcome Measures:
  • Number of participants with pre-specified adverse events [ Time Frame: up to 63 weeks ] [ Designated as safety issue: Yes ]
    The number (percentage) of participants with an infusion reaction, anaphylaxis or immune complex related adverse event at any time in the study will be summarized.


Secondary Outcome Measures:
  • Serum uric acid response [ Time Frame: Up to 51 weeks ] [ Designated as safety issue: No ]
    Treatment responder will be defines as a participant whose serum uric acid values were <6 mg/dL at their final 2 consecutive (on drug) study visits.

  • Change from Baseline in Number of Swollen Joints at 25 weeks [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Swollen Joints at 51 weeks [ Time Frame: 51 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Tender Joints at 25 weeks [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Tender Joints at 51 weeks [ Time Frame: 51 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Tophi at 25 weeks [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Tophi at 51 weeks [ Time Frame: 51 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Swollen Joints at Early Discontinuation [ Time Frame: up to 50 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Tender Joints at Early Discontinuation [ Time Frame: up to 50 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Tophi at Early Discontinuation [ Time Frame: up to 50 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Gout Flares at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Baseline refers to participant's reported history upon enrollment.

  • Change from Baseline in Number of Gout Flares in weeks 6-12 [ Time Frame: Weeks 6 to 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Gout Flares in Months 3-6 [ Time Frame: Months 3 to 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Gout Flares in Months 6-9 [ Time Frame: Months 6 to 9 ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Gout Flares in Months 9-12 [ Time Frame: Months 9 to 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Gout Flares in Months 12-15 [ Time Frame: Months 12 to 15 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum samples


Estimated Enrollment: 1500
Study Start Date: October 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
KRYSTEXXA
All participants with exposure to pegloticase
Biological: pegloticase
pegloticase 8 mg intravenous every 2 weeks
Other Name: KRYSTEXXA

Detailed Description:

This is a Phase 4, multicenter, open-label, single-arm observational study of KRYSTEXXA 8 mg i.v. every 2 weeks in adult hyperuricemic patients with gout refractory to conventional therapy. Approximately 1500 patients will be enrolled in order to observe treatment of up to 500 patients at approximately 300 centers in the United States (US). Study duration is approximately 63 weeks, including 51 weeks of treatment and 12 weeks of follow-up. The proposed patient number and 1 year duration of the study will significantly extend the patient exposure to KRYSTEXXA compared with the pre-marketing controlled clinical trials.

The design of this study follows the FDA-approved Full Prescribing Information for the use of KRYSTEXXA and allows for capturing additional data related to the safety and efficacy of KRYSTEXXA within the standard healthcare setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patient population in this study will be hyperuricemic (serum uric acid (SUA) > 6 mg/dL) adult men and women (age 18 or greater) diagnosed with chronic gout and who are refractory to conventional therapy. Gout refractory to conventional therapy occurs in 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. To enter this study, the patient and the physician must have decided to begin treatment with KRYSTEXXA.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466166

Contacts
Contact: PPD 855-831-9273 savientkrystexxa@ppdi.com

  Show 106 Study Locations
Sponsors and Collaborators
Crealta Pharmaceuticals LLC
Investigators
Study Director: Steven Pollock, RPh Crealta Pharmaceuticals LLC
  More Information

Publications:
Responsible Party: Crealta Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01466166     History of Changes
Other Study ID Numbers: M0401
Study First Received: October 28, 2011
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014