Apremilast Therapy for Acute Gouty Arthritis

Dartmouth Health

Status and phase

Withdrawn

Phase 2

Conditions

Acute Gout

Treatments

Drug: indomethacin SR

Drug: apremilast

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00997581

AP-GOUT-PI-0038

Details and patient eligibility

About

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.

Full description

WITHDRAWN

Sex

Male

Ages

18+ years old

Volunteers

No 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)