Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.

This study is limited to four study centers in the US.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00325195

Gout

COMPLETED PHASE3

Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

NCT01356498

Gout

COMPLETED PHASE3

Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout

NCT00111657

Gout

COMPLETED PHASE2

A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy

NCT00080210

Gout

COMPLETED PHASE2

Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid

NCT02959918

Gout Chronic Hyperuricemia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Gout Refractory to Conventional Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pegloticase

Group Type EXPERIMENTAL

pegloticase 8 mg i.v.

Intervention Type DRUG

pegloticase 8 mg i.v. every 2 weeks for 24 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pegloticase 8 mg i.v.

pegloticase 8 mg i.v. every 2 weeks for 24 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Previous treatment in studies of pegloticase i.v.
* Last exposure to pegloticase i.v. greater than one year prior to study entry
* Symptomatic gout
* Documented hyperuricemic (SUA ≥ 7 mg/dL)

Exclusion Criteria

* Prior exposure to Elitek® (rasburicase)
* Unstable angina
* Uncontrolled arrhythmia or hypertension
* Non-compensated congestive heart failure
* End stage renal disease requiring dialysis
* Concomitant use of SUA lowering agents and use of other investigational drugs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No