Trial Outcomes & Findings for Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis (NCT NCT01830699)
NCT ID: NCT01830699
Last Updated: 2014-08-04
Results Overview
The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: \< 15 = no problem, 16 - 40 = problem, but working, \> 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.
COMPLETED
NA
33 participants
4 weeks
2014-08-04
Participant Flow
Subject recruitment was from March 2013 to December 2013. Subjects were recruited from the Internal Medicine (IM) or IM Subspecialties Clinic at a single academic community-size hospital.
Please refer to inclusion and exclusion criteria.
Participant milestones
| Measure |
Triamcinolone (Kenalog)
A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )
|
Rilonacept
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
20
|
|
Overall Study
COMPLETED
|
13
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis
Baseline characteristics by cohort
| Measure |
Triamcinolone (Kenalog)
n=13 Participants
A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )
|
Rilonacept
n=20 Participants
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 13.7 • n=99 Participants
|
64.5 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
65.3 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
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
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 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
|
11 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
30 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
|
13 participants
n=99 Participants
|
20 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Site of subacromial injection
Right Bursa injected
|
6 participants
n=99 Participants
|
14 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Site of subacromial injection
Left Bursa injected
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: \< 15 = no problem, 16 - 40 = problem, but working, \> 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.
Outcome measures
| Measure |
Triamcinolone (Kenalog)
n=13 Participants
A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )
|
Rilonacept
n=20 Participants
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once
|
|---|---|---|
|
Improvement in Shoulder Function
|
15.92 units on a scale
Standard Deviation 15.40
|
38.52 units on a scale
Standard Deviation 25.07
|
SECONDARY outcome
Timeframe: 4 weeksSecondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life).
Outcome measures
| Measure |
Triamcinolone (Kenalog)
n=13 Participants
A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )
|
Rilonacept
n=20 Participants
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once
|
|---|---|---|
|
Improvement in Pain
|
2.27 units on a scale
Standard Deviation 1.42
|
3.85 units on a scale
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: 4 weeksAny adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.
Outcome measures
| Measure |
Triamcinolone (Kenalog)
n=13 Participants
A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )
|
Rilonacept
n=20 Participants
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
3 participants
|
8 participants
|
Adverse Events
Triamcinolone (Kenalog)
Rilonacept
Serious adverse events
| Measure |
Triamcinolone (Kenalog)
n=13 participants at risk；n=12 participants at risk
A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )
|
Rilonacept
n=20 participants at risk
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
8.3%
1/12 • Number of events 12 • 1 year
|
5.0%
1/20 • Number of events 20 • 1 year
|
Other adverse events
| Measure |
Triamcinolone (Kenalog)
n=13 participants at risk；n=12 participants at risk
A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.
Corticosteroid (Triamcinolone (Kenalog) )
|
Rilonacept
n=20 participants at risk
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Rilonacept: 160 mg intra-bursal once
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/13 • 1 year
|
10.0%
2/20 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • 1 year
|
10.0%
2/20 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Injection Site Reaction
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/20 • 1 year
|
|
Infections and infestations
Thrush
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/20 • 1 year
|
|
Infections and infestations
Acute Bronchitis
|
0.00%
0/13 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized Stiffness
|
0.00%
0/13 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hand Tingling
|
0.00%
0/13 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place