Apremilast Therapy for Acute Gouty Arthritis

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Gout
• Intervention / Treatment: Drug: apremilast; Drug: indomethacin SR

Detailed Description

WITHDRAWN

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Day 1, Day 7 and Day 21.

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety (type, frequency, severity, and relationship of adverse events to apremilast, laboratory, ECG, physical exam or other changes) and tolerability	Day 1, Day 7 and Day 21.
Quality of Life	Assessed at Day 1, Day 7 and Day 21 study visits

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Celgene Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: October 9, 2009
• First Submitted That Met QC Criteria: October 16, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Gout
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis, Gouty; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Phosphodiesterase Inhibitors; Gout Suppressants; Tocolytic Agents; Phosphodiesterase 4 Inhibitors; Indomethacin; Apremilast
• Other Study ID Numbers: AP-GOUT-PI-0038