Apremilast Therapy for Acute Gouty Arthritis

Condition(s) targeted: Acute Gout

Intervention: apremilast (Drug); indomethacin SR (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Dartmouth-Hitchcock Medical Center

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.

Official title: Apremilast Therapy for Acute Gouty Arthritis

Study design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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

Quality of Life

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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)

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Starting date: January 2010
Last updated: October 16, 2009