Apremilast Therapy for Acute Gouty Arthritis
This study has been withdrawn prior to enrollment.
(Colaborator withdrew support.)
Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborator:
Celgene Corporation
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00997581
First received: October 9, 2009
Last updated: July 5, 2011
Last verified: July 2011
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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 2 |
| 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:
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 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 June 17, 2013