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GoutPhase 3NCT01356498

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

A Phase 3 study testing pegloticase in people with Gout, run by Savient Pharmaceuticals at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout
What is being tested?
pegloticase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
22 sitesUnited States
Study dates
Dec 2006to Jan 2010
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

  • Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout

Who cannot join

  • unstable angina
  • uncontrolled arrhythmia
  • uncontrolled hypertension
  • end stage renal disease requiring dialysis
  • anemia

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Peter A. Holt, M.D.

    Baltimore, Maryland, 21239

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • The University of Chicago

    Chicago, Illinois, 60637

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • The Ohio State University

    Columbus, Ohio, 43210

  • STAT Research, Inc.

    Dayton, Ohio, 45402

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Duke University Medical Center

    Durham, North Carolina, 27302

  • Justus J. Fiechtner, MD, PC

    Lansing, Michigan, 48910

  • David R. Mandel, MD, Inc.

    Mayfield Village, Ohio, 44143

  • Ocala Rheumatology Research Center

    Ocala, Florida, 34474

  • Mid Atlantic Research Assoc.

    Philadelphia, Pennsylvania, 19154

  • CentraCare Clinic

    Saint Cloud, Minnesota, 56377

  • Kaiser Permanente Medical Center, Clinical Trials Unit

    San Francisco, California, 94118

  • Pacific Arthritis Center Medical Group

    Santa Maria, California, 93454

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • St. Petersburg Arthritis Center

    St. Petersburg, Florida, 33703

  • Rheumatology Associates of North Jersey

    Teaneck, New Jersey, 07666

  • Veterans Affairs Medical Center

    Washington D.C., District of Columbia, 20422

  • Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Agilence Arthritis & Osteoporosis Medical Center

    Whittier, California, 90606

Other trials in United States

About this study

Official title: Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout

This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.

Conditions
Gout
Being tested
pegloticase
Keywords
gout, chronic gout
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pegloticaseBiological

    8 mg intravenous infusion

Study groups in NCT01356498
Study groupRoleWhat they receive
q2 RCTExperimentalPegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study
Receives: Biological: pegloticase
q4 RCTExperimentalPegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study
Receives: Biological: pegloticase
Placebo in RCTExperimentalPlacebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE
Receives: Biological: pegloticase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uric Acid (mg/dL)

    Uric acid measured at 3 month-intervals

    Measured: Week 13, Week 25, Week 53, Week 101

Secondary outcomes (4)

  1. Tophus Response

    Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.

    Measured: Up to 2 years

  2. Patient Reported Outcome: SF-36 Physical Component Summary Score

    SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best).

    The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status.

    Measured: RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101

  3. Gout Flare Frequency

    The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment

    Measured: Up to 2 years

  4. Gout Flare Incidence

    Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.

    Measured: Assessed in 3-month intervals up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2011 (estimated)
  2. Study startDec 2006
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01356498
Sponsor's protocol ID
C0407
Status last verified
Oct 2011
First submitted
27 Oct 2008
Last updated
2 Dec 2011
Data monitoring committee
No

Publications

  • Pillinger MH, Fields TR, Yeo AE, Lipsky PE. Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase. J Rheumatol. 2020 Apr;47(4):605-612. doi: 10.3899/jrheum.190161. Epub 2019 Jun 15.

    PubMed 31203212

  • Lipsky PE, Calabrese LH, Kavanaugh A, Sundy JS, Wright D, Wolfson M, Becker MA. Pegloticase immunogenicity: the relationship between efficacy and antibody development in patients treated for refractory chronic gout. Arthritis Res Ther. 2014 Mar 4;16(2):R60. doi: 10.1186/ar4497.

    PubMed 24588936

  • Baraf HS, Becker MA, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, Rehrig CD, Ottery FD, Sundy JS, Yood RA. Tophus burden reduction with pegloticase: results from phase 3 randomized trials and open-label extension in patients with chronic gout refractory to conventional therapy. Arthritis Res Ther. 2013 Sep 26;15(5):R137. doi: 10.1186/ar4318.

    PubMed 24286509

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pegloticase in people with Gout, run by Savient Pharmaceuticals at 22 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 1 inclusion and 5 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 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 2 Dec 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?

Uric Acid (mg/dL) (time frame: Week 13, Week 25, Week 53, Week 101). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01356498, which also lists 3 linked publications.

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 2 Dec 2011.

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