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Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416402
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : April 3, 2015
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

Brief Summary:
The purpose of this study is to determine whether arhalofenate is safe and effective when dosed in combination with febuxostat in lowering serum uric acid in patients with gout.

Condition or disease Intervention/treatment Phase
Hyperuricemia Gout Drug: Arhalofenate Drug: Febuxostat Drug: Colchicine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Arhalofenate (MBX-102) in Combination With Febuxostat for the Treatment of Hyperuricemia in Patients With Gout
Study Start Date : August 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Arhalofenate with febuxostat and colchicine Drug: Arhalofenate
400 mg once daily orally for two weeks then up-titrated to 600 mg once daily orally for an additional two weeks
Other Name: MBX-102

Drug: Febuxostat
80 mg once daily orally for 5 weeks
Other Name: Uloric

Drug: Colchicine
Colchicine 0.6 mg daily as prophylaxis to prevent gout flares
Other Name: Colcrys

Primary Outcome Measures :
  1. Proportion of patients achieving sUA <6.0 mg/dL, <5.0 mg/dL, <4.0 mg/dL and <3.0 mg/dL at the end of combination treatment period with each of the doses of arhalofenate [ Time Frame: 36 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Known gout patient (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout in Appendix 3) with a serum uric acid value of at least 8.0 mg/dL at Screening Visit. Patients on allopurinol must agree to discontinue their existing therapy at Visit 1 through the entire duration of the study and must have a sUA value of at least 8.0 mg/dL after a minimum 2 week wash-out at Visit 2.
  2. Male or female, 18-75 years of age at Screening Visit
  3. All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method (see the list in Appendix 4) for the entire duration of the study unless report of complete sexual abstinence.
  4. Female patients must not be pregnant or lactating
  5. Male patients with a female partner of child-bearing potential must agree to use condom or the partner must use a medically acceptable method of contraception for the entire duration of the study.
  6. Estimated CrCl ≥ 50 mL/min as calculated by the by Cockcroft-Gault method
  7. Serum creatinine value must be ≤ 1.3 mg/dL in females and ≤ 1.4 mg/dL in males
  8. Patients must have liver function tests (LFTs) ≤ 1.5X ULN for AST, ALT and T-bilirubin, ≤ 2X ULN for ALP, ≤ 3X ULN for GGT; CK ≤ 3X ULN
  9. All other clinical laboratory parameters must be within normal limits or considered not clinically significant
  10. Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically significant
  11. Patients must have a systolic blood pressure ≤ 160 mm Hg and a diastolic blood pressure ≤ 95 mm Hg; known hypertensive patients controlled with medication other than diuretics (BP reading as above) may be included
  12. Patients must agree to remain in-clinic for 37 days consecutively and agree to follow the study procedures as described in the protocol

Exclusion Criteria:

  1. Treatment with any ULT other than allopurinol (e.g., probenecid, benzbromarone, febuxostat, or pegloticase) within two weeks of the Screening Visit
  2. Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant).
  3. Diagnosis of xanthinuria
  4. History of documented or suspected kidney stones
  5. Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
  6. History of illicit drug or alcohol abuse within one year of Screening Visit
  7. History of significant pulmonary disease, upper gastrointestinal (GI) bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), or nephrotic syndrome within three years of Screening Visit
  8. History of stroke, TIA, acute myocardial infarction (MI), congestive heart failure (CHF) (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 5 years of screening
  9. Malignancy within five years of Screening Visit (except successfully treated basal cell carcinoma)
  10. Body mass index (BMI) > 42 kg/m2
  11. Current or expected requirement for anticoagulant therapy [except for low-dose (≤ 325 mg/day) aspirin and/or Plavix® 75 mg/day]
  12. Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment
  13. Current or expected treatment with potent CYP3A4 inhibitors (See Appendix 6), cytotoxic agents (azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophyline, desipramine, sulphonylurea, thiazolidinedione, diuretics, atypical antipsychotic agents, or phenytoin
  14. Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs use to treat acute gout flares is permitted)
  15. Current or expected treatment with systemic corticosteroids (except topical, ophthalmic, intra-articular, or inhaled at a dose < 1600 μg/day) other than to treat acute gout flares
  16. Known hypersensitivity to colchicine or febuxostat
  17. Treatment with any other investigational therapy within the 30 days prior to the Screening Visit, or patients who received at least one dose of blinded study medication while enrolled in any previous arhalofenate trial
  18. Any other condition that compromises the ability of the patient to provide informed consent or to comply with the objectives and procedures of this protocol, as judged by the investigator and/or medical monitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416402

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United States, Kansas
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
CymaBay Therapeutics, Inc.
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Responsible Party: CymaBay Therapeutics, Inc. Identifier: NCT01416402    
Other Study ID Numbers: M102-21124
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015
Keywords provided by CymaBay Therapeutics, Inc.:
serum uric acid
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents