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Apremilast Therapy for Acute Gouty Arthritis

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: NCT00997581
Recruitment Status : Withdrawn (Colaborator withdrew support.)
First Posted : October 19, 2009
Last Update Posted : April 2, 2018
Celgene Corporation
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:

The purpose of the study is to learn about a possible new medicine, apremilast, for treating acute gout and compare how it works to indomethacin, a medication that has been used to treat gout for over 50 years.

In order to learn about apremilast, half the participants in this study will receive apremilast and half the participants in this study will receive indomethacin.

This study will measure the severity and duration of acute gout attacks in research participants, as well as measures of quality of life and any side effects or adverse reactions to the medication.

There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate response to treatment with study medication at Day 7, and a follow-up visit at Day 21.

Condition or disease Intervention/treatment Phase
Acute Gout Drug: apremilast Drug: indomethacin SR Phase 2

Detailed Description:

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Apremilast Therapy for Acute Gouty Arthritis
Estimated Study Start Date : April 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Arthritis Gout

Arm Intervention/treatment
Experimental: apremilast
Experimental treatment for acute gout
Drug: apremilast
apremilast 20 mg taken twice daily by mouth

Active Comparator: indomethacin
Medication currently used for the treatment of acute gout
Drug: indomethacin SR
indomethacin SR 75 mg taken twice daily by mouth

Primary Outcome Measures :
  1. Subject-reported number of swollen joints, the number of tender joints, the number of warm joints, as well as self-report pain, global assessment, and functional status. Subject-reported time to resolution of symptoms will be measured. [ Time Frame: Day 1, Day 7 and Day 21. ]

Secondary Outcome Measures :
  1. Safety (type, frequency, severity, and relationship of adverse events to apremilast, laboratory, ECG, physical exam or other changes) and tolerability [ Time Frame: Day 1, Day 7 and Day 21. ]
  2. Quality of Life [ Time Frame: Assessed at Day 1, Day 7 and Day 21 study visits ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must understand and voluntarily sign the informed consent
  • Must have the diagnosis of gout proven by identification of urate crystals from body fluids
  • Must be male age >18 years at the time of consent
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must meet the following laboratory criteria:

    • Hemoglobin > 9.0 g/dL
    • White blood cell (WBC) count > 3000/μL and < 14,000/μL
    • Platelet count >100,000/μL
    • Serum creatinine < 2.0mg/dL
    • Total bilirubin < 2.0 mg/dL
    • Aspartate transaminase (AST) and alanine transaminase (ALT) <1.5 X upper limit of normal
  • Males, including those who have had a vasectomy, must agree to use barrier contraception (latex condom) when engaging in sexual activity with a female of child-bearing potential (FCBP) while on study medications and for 84 days after taking the last does of the medication

Exclusion Criteria:

  • Inability to provide voluntary consent
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret the data from the study
  • Females
  • Systemic fungal infection
  • History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment in the past 2 years
  • An active infection at presentation
  • Use of any investigational medication within 4 weeks prior to start of study or 5 pharmacokinetic/pharmacodynamic half-lives, whichever is longer
  • Any use of corticosteroids, cyclosporine, methotrexate, cyclophosphamide, azathioprine, mycophenolate within 4 weeks prior to start of study
  • Any clinically significant abnormality on 12-lead ECG screening
  • Malignancy or history of malignancy (except for treated and cured basal-cell skin carcinomas > 3 years prior to screening)

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): NCT00997581

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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Celgene Corporation
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Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00997581    
Other Study ID Numbers: AP-GOUT-PI-0038
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Keywords provided by Dartmouth-Hitchcock Medical Center:
Additional relevant MeSH terms:
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Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action