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GoutPhase 2NCT02063997

Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients

A Phase 2 study testing Arhalofenate 600 mg, Allopurinol 300 mg and Colchicine 0.6 mg in people with Gout, run by Gilead Sciences at 56 sites in 3 countries.

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

The purpose of this study is to determine whether arhalofenate is effective in preventing flares and reducing serum uric acid in gout patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gout
What is being tested?
Arhalofenate 600 mg, Allopurinol 300 mg and Colchicine 0.6 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
56 sitesin 3 countries
Study dates
Mar 2014to Jan 2015
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients between 18 and 75 years of age, inclusive
  • Known gout diagnosis (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout, see Appendix 3)
  • At least three patient-reported and documented flares during the 12 months prior to screening (the first of these flares may have resulted in the gout diagnosis; any recent flare must have resolved, with the patient back to usual comfort level at least seven days prior to screening)
  • Have not used any ULT since at least two weeks prior to screening
  • Have not used colchicine since at least two weeks prior to screening
  • Usual level of resting pain when NOT experiencing flare is three or less on an 11-point numerical rating scale (NRS)
Show all 17Show fewer
  • Have a sUA ≥ 7.5 mg/dL and ≤ 12 mg/dL at screening
  • All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least two years); or have a partner who has undergone vasectomy or must agree to use two medically accepted methods of contraception including a barrier method (see Appendix 4) for the entire duration of study participation unless she reports complete sexual abstinence. Female patients must not be pregnant or lactating
  • Estimated creatinine clearance (eCrCl) ≥ 60 ml/min/1.73m2 calculated by Cockcroft-Gault method at screening
  • Liver function tests ≤ 3X ULN for AST, ALT and total bilirubin; ≤ 3X ULN for ALP and GGT; and ≤ 3X ULN for CK at screening
  • All other clinical laboratory parameters must be within normal limits or considered not clinically significant
  • Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically significant at screening
  • Systolic blood pressure ≤ 160 mm Hg and diastolic blood pressure ≤ 90 mm Hg at screening; known hypertensive patients stable (blood pressure [BP] reading as above) with medication may be included
  • Patients using agents known to influence sUA levels (see Appendix 7) must be on a stable dose and regimen for at least two weeks prior to screening and must be willing to continue the same doses and regimens during study participation
  • Expected to be able to tolerate a short course of either oral NSAIDs and/or oral steroids as may be needed to treat a flare
  • Must be able to swallow tablets/capsules
  • Following training, must be willing and able to understand and complete an electronic diary

Who cannot join

  • Receiving treatment with allopurinol, colchicine, probenecid, benzbromarone, or febuxostat within two weeks or pegloticase within six months prior to screening
  • Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder or organ transplant)
  • Diagnosis of xanthinuria
  • Fractional excretion of urate > 10% at screening
  • History of documented or suspected kidney stones
  • Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
Show all 21Show fewer
  • A diagnosis of illicit drug or alcohol dependence or abuse within one year of screening
  • History of upper gastrointestinal (GI) bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), within three years of screening
  • History of stroke, transient ischemic attack (TIA), acute myocardial infarction (MI), congestive heart failure (NYHA Class II-IV), angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization), lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within five years of screening
  • History of cancer within five years of screening, with the following exceptions: adequately treated non-melanomatous skin cancers, non-metastatic prostate cancer or in situ cervical cancer
  • Patients with a history of bladder cancer, active bladder cancer or hematuria
  • Body mass index (BMI) > 42 kg/m2 at screening
  • Current or expected requirement for anticoagulant therapy (except for aspirin ≤ 325 mg/day, clopidogrel [Plavix] ≤ 75 mg/day, or prasugrel [Effient] ≤ 10 mg/day)
  • Use of any of the following within eight weeks prior to screening: potent CYP3A4 inhibitors, cytotoxic agents (including azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones (e.g., rosiglitazone or pioglitazone), atypical antipsychotic agents, ampicillin, amoxicillin, loop diuretics or phenytoin
  • Chronic treatment with NSAIDs (except for as needed [prn] use to treat acute events); per protocol a short course of oral NSAIDs may be used to treat flares during the study
  • Current or expected chronic treatment with systemic corticosteroids (topical, ophthalmic, intra-articular or inhaled corticosteroid at a dose < 1600 μg/day is permitted); per protocol a short course of oral corticosteroid may be used to treat flares occurring during the study
  • History of intra-articular steroid injection to treat flare within four weeks of screening
  • Known hypersensitivity or intolerance to allopurinol or colchicine
  • Treatment with any other investigational therapy within 30 days or within five half lives, whichever is longer, prior to screening
  • Patients who received arhalofenate in a previous trial
  • Any other condition(s) that would compromise the safety of the patient, prevent compliance with the study protocol including ability to use an electronic diary, or compromise the quality of the clinical study, as judged by the Investigator and/or Medical Monitor

Trial locations and contacts

56 sites in 3 countries.

56 sites in 3 countries

United States52 sites

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Study site

    Bowling Green, Kentucky

  • Study site

    Bristol, Tennessee

  • Study site

    Brooklyn, New York

  • Study site

    Brownsburg, Indiana

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarksburg, West Virginia

  • Study site

    Clearwater, Florida

  • Study site

    DeLand, Florida

  • Study site

    Denver, Colorado

  • Study site

    El Cajon, California

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Hagerstown, Maryland

  • Study site

    Hickory, North Carolina

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Jackson, Tennessee

  • Study site

    Johnstown, Pennsylvania

  • Study site

    Jupiter, Florida

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Missoula, Montana

  • Study site

    New Port Richey, Florida

  • Study site

    New York, New York

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Owensboro, Kentucky

  • Study site

    Palm Harbor, Florida

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    Scottsdale, Arizona

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Summerville, South Carolina

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Jordan, Utah

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Wyomissing, Pennsylvania

Other trials in United States

Canada3 sites

  • Study site

    Newmarket, Ontario

  • Study site

    Sarnia, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

Georgia1 site

  • Study site

    Tbilisi

Other trials in Georgia

About this study

Official title: A Randomized, Double-Blind, Active and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients

The purpose of this study is to determine whether arhalofenate is effective in preventing flares and reducing serum uric acid in gout patients.

Conditions
Gout
Being tested
Arhalofenate 600 mg, Allopurinol 300 mg, Colchicine 0.6 mg, Placebo, Arhalofenate 800 mg
Medical subject headings
Gout

What participants receive

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

  • Arhalofenate 600 mgDrug

    Arhalofenate 600 mg tablets once daily for 12 weeks

  • Allopurinol 300 mgDrug

    Allopurinol 300 mg tablets once daily for 12 weeks

  • Colchicine 0.6 mgDrug

    Colchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks

  • PlaceboDrug

    Placebo tablets once daily for 12 weeks

  • Arhalofenate 800 mgDrug

    Arhalofenate 800 mg tablets once daily for 12 weeks

Study groups in NCT02063997
Study groupRoleWhat they receive
Arhalofenate 600 mgExperimentalNot described
Receives: Drug: Arhalofenate 600 mg
Arhalofenate 800 mgExperimentalNot described
Receives: Drug: Arhalofenate 800 mg
Allopurinol 300 mg; colchicine 0.6 mgActive comparatorNot described
Receives: Drug: Allopurinol 300 mg; Drug: Colchicine 0.6 mg
Allopurinol 300 mgActive comparatorNot described
Receives: Drug: Allopurinol 300 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. The incidence of flares (mean number of flares per patient) from baseline through Week 12 in the arhalofenate 800 mg group compared to the allopurinol 300 mg group.

    Measured: 12 weeks

Secondary outcomes (7)

  1. Percent sUA reduction from baseline to Week 12 in the arhalofenate 800 mg group compared to the placebo group

    Measured: 12 weeks

  2. Percent sUA reduction from baseline to Week 12 in the arhalofenate 600 mg group compared to the placebo group

    Measured: 12 weeks

  3. Proportion of patients with sUA < 6 mg/dL at Week 12 in the arhalofenate 800 mg group compared to the placebo group

    Measured: 12 weeks

  4. The incidence of flares from baseline through Week 12 in the arhalofenate 600 mg group compared to the allopurinol 300 mg group

    Measured: 12 weeks

  5. Proportion of patients with sUA < 6 mg/dL at Week 12 in the arhalofenate 600 mg group compared to placebo group

    Measured: 12 weeks

  6. Time from baseline to onset of first flare for the arhalofenate 800 mg group compared to the allopurinol 300 mg group

    Measured: 12 weeks

  7. Time from baseline to onset of first flare for the arhalofenate 600 mg group compared to the allopurinol 300 mg group

    Measured: 12 weeks

Timeline

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

  1. First posted17 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02063997
Sponsor's protocol ID
CB102-21425
Status last verified
Jan 2018
First submitted
12 Feb 2014
Last updated
29 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • Poiley J, Steinberg AS, Choi YJ, Davis CS, Martin RL, McWherter CA, Boudes PF; Arhalofenate Flare Study Investigators. A Randomized, Double-Blind, Active- and Placebo-Controlled Efficacy and Safety Study of Arhalofenate for Reducing Flare in Patients With Gout. Arthritis Rheumatol. 2016 Aug;68(8):2027-34. doi: 10.1002/art.39684.

    PubMed 26989892

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arhalofenate 600 mg, Allopurinol 300 mg and Colchicine 0.6 mg in people with Gout, run by Gilead Sciences at 56 sites in 3 countries.

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 17 inclusion and 21 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Canada, Georgia. 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. Some participants in this study may receive a placebo. 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.

What does the primary outcome measure?

The incidence of flares (mean number of flares per patient) from baseline through Week 12 in the arhalofenate 800 mg group compared to the allopurinol 300 mg group. (time frame: 12 weeks). 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 NCT02063997, 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 29 Jan 2018.

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