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The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Other | daily placebo dosing for 16 weeks with background allopurinol therapy |
|
| Colchicine (Colcrys®) | Active Comparator | daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine (Colcrys®) | Drug | daily 0.6 mg colchicine dosing for 16 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Gout Flares Per Participant From Day 1 to Week 16 | Day 1 to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 | Day 1 to Week 16 | |
| Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 | Day 1 to Week 16 | |
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Inclusion Criteria:
Inclusion criteria include, but are not limited to the following:
Exclusion Criteria:
Exclusion criteria include, but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabaster | Alabama | United States | ||||
Participants were assessed at an initial screening visit within 3 to 14 days before the baseline visit. At the baseline visit, eligible participants were then assessed, randomized, trained on daily dosing & the daily dosing/flare diary, and initiated on allopurinol and study drug (colchicine or placebo).
Overall, 82 patients from 20 clinical sites participated in the study between 19-October-2011 to 27-August-2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | daily placebo dosing for 16 weeks with background allopurinol therapy |
| FG001 | Colchicine (Colcrys®) 0.6mg | daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo |
| Drug |
daily placebo dosing for 16 weeks |
|
| allopurinol | Drug | background therapy |
|
| Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 |
| Day 1 to Week 16 |
| Mesa |
| Arizona |
| United States |
| Upland | California | United States |
| Trumbull | Connecticut | United States |
| DeBary | Florida | United States |
| Jacksonville | Florida | United States |
| Kissimmee | Florida | United States |
| Canton | Georgia | United States |
| Boise | Idaho | United States |
| Lexington | Kentucky | United States |
| Bethesda | Maryland | United States |
| Reisterstown | Maryland | United States |
| Bingham Farms | Michigan | United States |
| Brooklyn Center | Minnesota | United States |
| Kansas City | Missouri | United States |
| Billings | Montana | United States |
| Elizabeth | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Charlotte | North Carolina | United States |
| Hickory | North Carolina | United States |
| Morganton | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Duncansville | Pennsylvania | United States |
| Reading | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Greer | South Carolina | United States |
| Mt. Pleasant | South Carolina | United States |
| Johnson City | Tennessee | United States |
| Dallas | Texas | United States |
| Katy | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| West Jordan | Utah | United States |
| Norfolk | Virginia | United States |
| Seattle | Washington | United States |
| Wauwatosa | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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The study population consisted of adults who met the criteria of the ARA for acute arthritis of primary gout or had monosodium urate monohydrate microcrystals identified in joint fluid, had tophi present in joints or a history of polyarticular gout attacks, a history of ≥2 gout flares in the past year, and were initiating therapy with allopurinol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | daily placebo dosing for 16 weeks with background allopurinol therapy |
| BG001 | Colchicine (Colcrys®) 0.6mg | daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Gout Flares Per Participant From Day 1 to Week 16 | Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized). | Posted | Mean | Standard Deviation | gout flares | Day 1 to Week 16 |
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| Secondary | Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 | Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 to Week 16 |
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| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 | Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 to Week 16 |
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| ||||||||||||||||||||||||||||||
| Secondary | Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 | Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized). | Posted | Mean | Standard Deviation | days | Day 1 to Week 16 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | daily placebo dosing for 16 weeks with background allopurinol therapy | 0 | 41 | 20 | 41 | ||
| EG001 | Colchicine (Colcrys®) 0.6mg | daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy | 1 | 41 | 20 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
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This clinical trial was not directly related to the development of an investigational/medicinal product.
Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron | 914 847 5385 | clinicaltrials@regeneron.com |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| >=65 years |
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| Male |
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