Chronic Gout Refractory to Conventional TherapyPhase 3NCT00675103
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
A Phase 3 study testing pegloticase 8 mg i.v. in people with Chronic Gout Refractory to Conventional Therapy, run by Savient Pharmaceuticals at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Gout Refractory to Conventional Therapy
- What is being tested?
- pegloticase 8 mg i.v.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2008to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Chicago- Dept. Biological Services
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
Portland Rheumatology Clinic, L.L.C.
Lake Oswego, Oregon, 97035
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.
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.
- Being tested
- pegloticase 8 mg i.v.
- Keywords
- Gout, Gouty Arthritis, Anti-Gout preparations
- Medical subject headings
- Gout, Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegloticase 8 mg i.v.Drug
pegloticase 8 mg i.v. every 2 weeks for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| pegloticase | Experimental | Not described Receives: Drug: pegloticase 8 mg i.v. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Profile
Number of participants reporting events
Measured: 6 months
Secondary outcomes (1)
Mean Plasma Uric Acid
This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.
Measured: Baseline, Week 3 and Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Gout Refractory to Conventional TherapyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675103
- Sponsor's protocol ID
- C0409
- Status last verified
- Jun 2011
- First submitted
- 6 May 2008
- Last updated
- 28 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.
- ClinicalTrials.gov ID
- NCT00675103
- Acronym / sponsor ID
- C0409
- Keywords
- Gout, Gouty Arthritis, Anti-Gout preparations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Savient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 28 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pegloticase | Experimental | Drug: pegloticase 8 mg i.v. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- Prior exposure to Elitek® (rasburicase)
- Unstable angina
- Uncontrolled arrhythmia or hypertension
- Non-compensated congestive heart failure
- End stage renal disease requiring dialysis
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 |
|---|---|---|
| pegloticase 8 mg i.v.pegloticase 8 mg i.v. every 2 weeks for 24 weeks | Drug | pegloticase |
Primary outcome
Adverse Event Profile
Time frame: 6 months
Number of participants reporting events
1 secondary outcome
Mean Plasma Uric Acid
Time frame: Baseline, Week 3 and Week 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pegloticase 8 mg i.v. in people with Chronic Gout Refractory to Conventional Therapy, run by Savient Pharmaceuticals at 4 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 4 inclusion and 6 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Adverse Event Profile (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2011.