Intercritical Gout
Conditions
Keywords
Gout
Brief summary
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.
Interventions
daily 0.6 mg colchicine dosing for 16 weeks
DRUGplacebo
daily placebo dosing for 16 weeks
DRUGallopurinol
background therapy
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria include, but are not limited to the following: 1. Men and postmenopausal women between the ages of 18 and 70 2. Meets the ARA criteria for classification of acute gout 3. Tophi present and/or a history of gout attacks in 2 or 3 joints 4. Self-reported history of at least 2 gout flares in the prior 12 months 5. Serum uric acid greater than or equal to 7.5 mg/dL at the first visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Gout Flares Per Participant From Day 1 to Week 16 | Day 1 to Week 16 |
Secondary
| Measure | 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 |
| Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 | Day 1 to Week 16 |
Countries
United States
Participant flow
Recruitment details
Overall, 82 patients from 20 clinical sites participated in the study between 19-October-2011 to 27-August-2012.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Placebo daily placebo dosing for 16 weeks with background allopurinol therapy | 41 |
| Colchicine (Colcrys®) 0.6mg daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy | 41 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Placebo | Colchicine (Colcrys®) 0.6mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 35 Participants | 74 Participants |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 40 Participants | 35 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 41 | 20 / 41 |
| serious Total, serious adverse events | 0 / 41 | 1 / 41 |
Outcome results
Primary
Number of Gout Flares Per Participant From Day 1 to Week 16
Time frame: Day 1 to Week 16
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Gout Flares Per Participant From Day 1 to Week 16 | 1.1 gout flares | Standard Deviation 1.9 |
| Colchicine (Colcrys®) 0.6mg | Number of Gout Flares Per Participant From Day 1 to Week 16 | 0.3 gout flares | Standard Deviation 0.56 |
Secondary
Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16
Time frame: Day 1 to Week 16
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 | 6.6 days | Standard Deviation 13.2 |
| Colchicine (Colcrys®) 0.6mg | Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 | 1.6 days | Standard Deviation 3.75 |
Secondary
Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
Time frame: Day 1 to Week 16
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 | 43.9 Percentage of Participants |
| Colchicine (Colcrys®) 0.6mg | Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 | 24.4 Percentage of Participants |
Secondary
Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16
Time frame: Day 1 to Week 16
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 | 24.4 Percentage of Participants |
| Colchicine (Colcrys®) 0.6mg | Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 | 4.9 Percentage of Participants |