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Recruitment Status : Withdrawn (Colaborator withdrew support.)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

Tracking Information
First Submitted Date  ICMJE October 9, 2009
First Posted Date  ICMJE October 19, 2009
Last Update Posted Date April 2, 2018
Estimated Study Start Date  ICMJE April 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
  • 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. ]
  • Quality of Life [ Time Frame: Assessed at Day 1, Day 7 and Day 21 study visits ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apremilast Therapy for Acute Gouty Arthritis
Official Title  ICMJE Apremilast Therapy for Acute Gouty Arthritis
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.

Detailed Description WITHDRAWN
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Gout
Intervention  ICMJE
  • Drug: apremilast
    apremilast 20 mg taken twice daily by mouth
  • Drug: indomethacin SR
    indomethacin SR 75 mg taken twice daily by mouth
Study Arms  ICMJE
  • Experimental: apremilast
    Experimental treatment for acute gout
    Intervention: Drug: apremilast
  • Active Comparator: indomethacin
    Medication currently used for the treatment of acute gout
    Intervention: Drug: indomethacin SR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 20, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2009)
20
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997581
Other Study ID Numbers  ICMJE AP-GOUT-PI-0038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE Not Provided
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP