GoutPhase 2NCT00080210
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
A Phase 2 study testing Puricase in people with Gout, run by Savient Pharmaceuticals at 9 sites in United States.
Trial summary
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gout
- What is being tested?
- Puricase
- How many people
- 40 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2004to Feb 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects to be included in the study are:
- Outpatients of either gender, age 18 or older
- Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis)
- Hyperuricemic: screening serum uric acid must be >=8 mg/dL.
- The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)
- Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide
Who cannot join
- Subjects to be excluded are those for whom any of the following apply:
- Unstable coronary artery disease or uncontrolled hypertension
- History of end stage renal disease requiring dialysis
- History of liver disease, as defined by baseline serum transaminase elevation >3X the upper limit of normal in the absence of any other known cause
- Organ transplant recipient requiring immunosuppressive therapy
- Concurrent use of prednisone at a dose >10 mg qd (or equivalent) at or within one week before dosing
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- Concurrent use of uric acid-lowering agents
- Prior treatment with Puricase® or other recombinant uricase
- An acute gout flare within one week prior to first treatment with Puricase® (exclusive of chronic synovitis/arthritis) requiring use of medication which violates the protocol
- glucose-6-phosphate dehydrogenase deficiency
- A history of anaphylactic reaction to a recombinant protein or porcine derivatives
- Lactation
- Has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
- Known allergy to urate oxidase or PEGylated products
- Has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Spain Rehabilitation Center
Birmingham, Alabama, 35294
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
University of Chicago Dept of Medicine
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
University of California, San Diego
La Jolla, California, 92037
North Shore University Hospital Division of Rheumatology
Manhasset, New York, 11030
Pride Clinical research Associates
Pittsburgh, Pennsylvania, 15219
Oregon Health & Science University Arthritis & Rheumatic Diseases
Portland, Oregon, 97239
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.
- Conditions
- Gout
- Being tested
- Puricase
- Keywords
- elevated uric acid, Elevated serum uric acid level, Symptomatic gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuricaseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2004 (estimated)
- Study startMar 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Savient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080210
- Sponsor's protocol ID
- C0403
- Status last verified
- May 2013
- First submitted
- 24 Mar 2004
- Last updated
- 3 Jun 2013
- Results posted
- No
Publications
Sundy JS, Becker MA, Baraf HS, Barkhuizen A, Moreland LW, Huang W, Waltrip RW 2nd, Maroli AN, Horowitz Z; Pegloticase Phase 2 Study Investigators. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: results of a phase II randomized study. Arthritis Rheum. 2008 Sep;58(9):2882-91. doi: 10.1002/art.23810.
PubMed 18759308
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
- ClinicalTrials.gov ID
- NCT00080210
- Acronym / sponsor ID
- C0403
- Conditions
- Gout
- Keywords
- elevated uric acid, Elevated serum uric acid level, Symptomatic gout
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Savient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Feb 2005
- First posted
- 25 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients of either gender, age 18 or older
- Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis)
- Hyperuricemic: screening serum uric acid must be >=8 mg/dL.
- The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)
- Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide
Key exclusion criteria (15 listed)
- Unstable coronary artery disease or uncontrolled hypertension
- History of end stage renal disease requiring dialysis
- History of liver disease, as defined by baseline serum transaminase elevation >3X the upper limit of normal in the absence of any other known cause
- Organ transplant recipient requiring immunosuppressive therapy
- Concurrent use of prednisone at a dose >10 mg qd (or equivalent) at or within one week before dosing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Puricase | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
- Derived from this study: PubMed 18759308Sundy JS, Becker MA, Baraf HS, Barkhuizen A, Moreland LW, Huang W, Waltrip RW 2nd, Maroli AN, Horowitz Z; Pegloticase Phase 2 Study Investigators. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: results of a phase II randomized study. Arthritis Rheum. 2008 Sep;58(9):2882-91. doi: 10.1002/art.23810.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Puricase in people with Gout, run by Savient Pharmaceuticals at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00080210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.