Apremilast Therapy for Acute Gouty Arthritis - Full Text View

Sponsor:	Dartmouth-Hitchcock Medical Center
Collaborator:	Celgene Corporation
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00997581

Purpose

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	Intervention	Phase
Acute Gout	Drug: apremilast Drug: indomethacin SR	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Apremilast Therapy for Acute Gouty Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Indomethacin Apremilast

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

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. [ Time Frame: Day 1, Day 7 and Day 21. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]
Quality of Life [ Time Frame: Assessed at Day 1, Day 7 and Day 21 study visits ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

WITHDRAWN

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997581

Locations

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

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Celgene Corporation

More Information

No publications provided

Responsible Party:	Robert Wortmann, MD, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00997581 History of Changes
Other Study ID Numbers:	AP-GOUT-PI-0038
Study First Received:	October 9, 2009
Last Updated:	July 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:

Gout

Additional relevant MeSH terms:

Arthritis
Arthritis, Gouty
Gout
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012