Apremilast Therapy for Acute Gouty Arthritis

NCT00997581 | Withdrawn Phase 2 DMC

• 1 other identifier: AP-GOUT-PI-0038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Gout

Keywords

Gout

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

apremilast

EXPERIMENTAL

Experimental treatment for acute gout

Drug: apremilast

indomethacin

ACTIVE COMPARATOR

Medication currently used for the treatment of acute gout

Drug: indomethacin SR

Interventions

apremilast DRUG

apremilast 20 mg taken twice daily by mouth

apremilast

indomethacin SR DRUG

indomethacin SR 75 mg taken twice daily by mouth

indomethacin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• 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.

  PMID: 34882311 DERIVED

MeSH Terms

Conditions

Gout

Interventions

apremilast

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 19, 2009
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

US (1)