Trial Outcomes & Findings for Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout (NCT NCT03636373)
NCT ID: NCT03636373
Last Updated: 2023-10-27
Results Overview
Pain intensity in the most affected baseline joint measured by the numeric 0-10 Visual Analog Scale at 72 hours with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
72 hours
Results posted on
2023-10-27
Participant Flow
Participant milestones
| Measure |
Etanercept
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale (VAS) of 0-10 at Visit 2
|
Triamcinolone Acetonide
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale (VAS) of 0-10 at Visit 2
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Etanercept
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale (VAS) of 0-10 at Visit 2
|
Triamcinolone Acetonide
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale (VAS) of 0-10 at Visit 2
|
|---|---|---|
|
Overall Study
Study closure due to Covid-19
|
1
|
0
|
Baseline Characteristics
Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
Baseline characteristics by cohort
| Measure |
Etanercept
n=3 Participants
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale (VAS) of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain.
|
Triamcinolone Acetonide
n=2 Participants
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale (VAS) of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Patient reported pain
|
7.67 units on a scale
n=99 Participants
|
6.00 units on a scale
n=107 Participants
|
7.00 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Evaluate the efficacy of etanercept, compared to triamcinolone acetonide in patients with acute gout attack
Pain intensity in the most affected baseline joint measured by the numeric 0-10 Visual Analog Scale at 72 hours with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
Outcome measures
| Measure |
Etanercept
n=3 Participants
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
Triamcinolone Acetonide
n=2 Participants
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
|---|---|---|
|
Joint Pain Intensity in the Most Affected Joint
|
5 score on a scale
Interval 0.0 to 8.0
|
1.5 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, Days 4, 7, and 14Population: 2 patients were enrolled in Triamcinolone acetonide arm and 3 patients were enrolled in Etanercept arm. However only two patients in the Etanercept arm completed the study. One patient completed only 2 study visits since the study was put on hold due to COVID-19 pandemic.
Patient's assessment of joint pain intensity in the most affected baseline joint on a numeric 0-10 Visual Analog Scale at Baseline and post-dose Days with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
Outcome measures
| Measure |
Etanercept
n=2 Participants
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
Triamcinolone Acetonide
n=3 Participants
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
|---|---|---|
|
Joint Pain on Numeric Pain Scale
Visit 1 (Baseline)
|
6 score on a scale
Interval 5.0 to 7.0
|
7.67 score on a scale
Interval 7.0 to 8.0
|
|
Joint Pain on Numeric Pain Scale
Visit 2 (Day 4)
|
1.5 score on a scale
Interval 0.0 to 3.0
|
5 score on a scale
Interval 0.0 to 8.0
|
|
Joint Pain on Numeric Pain Scale
Visit 3 (Day 7)
|
1 score on a scale
Interval 0.0 to 2.0
|
3 score on a scale
Interval 0.0 to 6.0
|
|
Joint Pain on Numeric Pain Scale
Visit 4 (Day 14)
|
1 score on a scale
Interval 0.0 to 2.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Day 4, 7 and 14Population: 4 subjects completed the study with 2 in each arm. Additionally, 1 more subject completed 2 visits (Day 1 and Day 4) only 2 visits in Etanercept arm. Therefore, 2 subjects in Triamcinolone acetonide completed Visit 2 while 3 subjects in Etanercept arm completed this Visit. However, out of the 2 participants who completed all study visits in the Etanercept arm, only 1 participant completed "Patient's assessment of response to treatment." Thus, only 1 participant was included in analysis.
Patient's global assessment of response to treatment (Likert), options are None, Poor, Acceptable, Good, Excellent
Outcome measures
| Measure |
Etanercept
n=2 Participants
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
Triamcinolone Acetonide
n=3 Participants
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
|---|---|---|
|
Patient's Assessment of Response to Treatment
Visit 2 (Day 4) · None
|
0 Participants
|
1 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 2 (Day 4) · Poor
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 2 (Day 4) · Acceptable
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 2 (Day 4) · Good
|
2 Participants
|
1 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 2 (Day 4) · Excellent
|
0 Participants
|
1 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 3 (Day 7) · None
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 3 (Day 7) · Poor
|
0 Participants
|
1 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 3 (Day 7) · Acceptable
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 3 (Day 7) · Good
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 3 (Day 7) · Excellent
|
2 Participants
|
1 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 4 (Day 14) · None
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 4 (Day 14) · Poor
|
0 Participants
|
1 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 4 (Day 14) · Acceptable
|
0 Participants
|
0 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 4 (Day 14) · Good
|
1 Participants
|
0 Participants
|
|
Patient's Assessment of Response to Treatment
Visit 4 (Day 14) · Excellent
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-dose days 4, 7 and 14Population: 2 patients were enrolled in Triamcinolone acetonide arm and 3 patients were enrolled in Etanercept arm. However only two patients in the Etanercept arm completed the study. One patient completed only 2 study visits since the study was put on hold due to COVID-19 pandemic.
Physician's global assessment of response to treatment None, Poor, Acceptable, Good, Excellent
Outcome measures
| Measure |
Etanercept
n=2 Participants
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
Triamcinolone Acetonide
n=3 Participants
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
|---|---|---|
|
Physician's Assessment of Response to Treatment
Visit 2 (Day 4) · None
|
0 Participants
|
1 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 2 (Day 4) · Poor
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 2 (Day 4) · Acceptable
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 2 (Day 4) · Good
|
1 Participants
|
2 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 2 (Day 4) · Excellent
|
1 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 3 (Day 7) · None
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 3 (Day 7) · Poor
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 3 (Day 7) · Acceptable
|
0 Participants
|
1 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 3 (Day 7) · Good
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 3 (Day 7) · Excellent
|
2 Participants
|
1 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 4 (Day 14) · None
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 4 (Day 14) · Poor
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 4 (Day 14) · Acceptable
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 4 (Day 14) · Good
|
0 Participants
|
1 Participants
|
|
Physician's Assessment of Response to Treatment
Visit 4 (Day 14) · Excellent
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline visit - Visit 1) through Day 14 (Visit 4).Population: 2 patients were enrolled in Triamcinolone acetonide arm and 3 patients were enrolled in Etanercept arm. However only two patients in the Etanercept arm completed the study. One patient completed only 2 study visits since the study was put on hold due to COVID-19 pandemic.
Total number of patients taking rescue medication after the administration of study medication while on study. Compare the use of rescue medication in etanercept and triamcinolone acetonide patients: for those patients having difficulty tolerating their pain, despite the treatment, were allowed to take rescue medication for pain. A paper diary was given to each patient at baseline visit to record the rescue medications.
Outcome measures
| Measure |
Etanercept
n=2 Participants
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
Triamcinolone Acetonide
n=3 Participants
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
|---|---|---|
|
Rescue Medication
Used Rescue Medications
|
1 Participants
|
2 Participants
|
|
Rescue Medication
Did not use Rescue Medications
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline visit - Visit 1) through Day 30 (Safety follow up phone visit -Visit 5)Population: 2 patients were enrolled in Triamcinolone acetonide arm and 3 patients were enrolled in Etanercept arm. However only two patients in the Etanercept arm completed the study. One patient completed only 2 study visits since the study was put on hold due to COVID-19 pandemic.
Safety and tolerability as assessed by subjects with adverse events and serious adverse events from baseline through Visit 5 safety follow-up
Outcome measures
| Measure |
Etanercept
n=2 Participants
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
Triamcinolone Acetonide
n=3 Participants
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a Visual Analog Scale of 0-10 at Visit 2 with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
|
|---|---|---|
|
Safety and Tolerability of Etanercept
Reported Adverse Events
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Etanercept
Did not report Adverse Events
|
1 Participants
|
2 Participants
|
Adverse Events
Etanercept
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Triamcinolone Acetonide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Etanercept
n=3 participants at risk
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Etanercept: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a pain scale of 0-10 at Visit 2
|
Triamcinolone Acetonide
n=2 participants at risk
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Triamcinolone Acetonide: Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a pain scale of 0-10 at Visit 2
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Swelling
|
0.00%
0/3 • 30 days
Adverse event related information was collected at baseline, visit 2, 3 and 4 and the phone call at the end of the study period (\~30 days)
|
50.0%
1/2 • Number of events 1 • 30 days
Adverse event related information was collected at baseline, visit 2, 3 and 4 and the phone call at the end of the study period (\~30 days)
|
|
General disorders
Fatigue
|
0.00%
0/3 • 30 days
Adverse event related information was collected at baseline, visit 2, 3 and 4 and the phone call at the end of the study period (\~30 days)
|
50.0%
1/2 • Number of events 1 • 30 days
Adverse event related information was collected at baseline, visit 2, 3 and 4 and the phone call at the end of the study period (\~30 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
33.3%
1/3 • Number of events 1 • 30 days
Adverse event related information was collected at baseline, visit 2, 3 and 4 and the phone call at the end of the study period (\~30 days)
|
0.00%
0/2 • 30 days
Adverse event related information was collected at baseline, visit 2, 3 and 4 and the phone call at the end of the study period (\~30 days)
|
Additional Information
Naomi Schlesinger, MD
Rutgers, The State University of New Jersey
Phone: 732 235 6117
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place