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Apremilast Therapy for Acute Gouty Arthritis

Primary Purpose

Acute Gout

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
apremilast
indomethacin SR
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gout focused on measuring Gout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

apremilast

indomethacin

Arm Description

Experimental treatment for acute gout

Medication currently used for the treatment of acute gout

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety (type, frequency, severity, and relationship of adverse events to apremilast, laboratory, ECG, physical exam or other changes) and tolerability
Quality of Life

Full Information

First Posted
October 9, 2009
Last Updated
March 29, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00997581
Brief Title
Apremilast Therapy for Acute Gouty Arthritis
Official Title
Apremilast Therapy for Acute Gouty Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Colaborator withdrew support.
Study Start Date
April 2010 (Anticipated)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gout
Keywords
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
apremilast
Arm Type
Experimental
Arm Description
Experimental treatment for acute gout
Arm Title
indomethacin
Arm Type
Active Comparator
Arm Description
Medication currently used for the treatment of acute gout
Intervention Type
Drug
Intervention Name(s)
apremilast
Intervention Description
apremilast 20 mg taken twice daily by mouth
Intervention Type
Drug
Intervention Name(s)
indomethacin SR
Intervention Description
indomethacin SR 75 mg taken twice daily by mouth
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
Quality of Life
Time Frame
Assessed at Day 1, Day 7 and Day 21 study visits

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34882311
Citation
van Durme CM, Wechalekar MD, Landewe RB, Pardo Pardo J, Cyril S, van der Heijde D, Buchbinder R. Non-steroidal anti-inflammatory drugs for acute gout. Cochrane Database Syst Rev. 2021 Dec 9;12(12):CD010120. doi: 10.1002/14651858.CD010120.pub3.
Results Reference
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Apremilast Therapy for Acute Gouty Arthritis

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