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Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

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ClinicalTrials.gov Identifier: NCT01830699
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Keesler Air Force Base Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Subacromial Bursitis
Interventions Drug: Rilonacept
Drug: Corticosteroid
Enrollment 33
Recruitment Details 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.
Pre-assignment Details Please refer to inclusion and exclusion criteria.
Arm/Group Title Triamcinolone (Kenalog) Rilonacept
Hide Arm/Group Description

A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.

Corticosteroid (Triamcinolone (Kenalog) )

160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.

Rilonacept: 160 mg intra-bursal once

Period Title: Overall Study
Started 13 20
Completed 13 20
Not Completed 0 0
Arm/Group Title Triamcinolone (Kenalog) Rilonacept Total
Hide Arm/Group Description

A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.

Corticosteroid (Triamcinolone (Kenalog) )

160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.

Rilonacept: 160 mg intra-bursal once

Total of all reporting groups
Overall Number of Baseline Participants 13 20 33
Hide Baseline Analysis Population Description
Prior to starting the trial, we anticipated having to recruit 150 subjects total (75 in each arm). At our first analysis of the data, the effect size of both the rilonacept and triamcinolone were larger than expected, and a re-calculated 'n' was 29 for an alpha of 0.05 and power of 1.0000 (effect size 1.1).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 20 participants 33 participants
65.6  (13.7) 64.5  (12.1) 65.3  (12.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 20 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  46.2%
12
  60.0%
18
  54.5%
>=65 years
7
  53.8%
8
  40.0%
15
  45.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 20 participants 33 participants
Female
8
  61.5%
12
  60.0%
20
  60.6%
Male
5
  38.5%
8
  40.0%
13
  39.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 20 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.0%
1
   3.0%
Native Hawaiian or Other Pacific Islander
1
   7.7%
0
   0.0%
1
   3.0%
Black or African American
1
   7.7%
0
   0.0%
1
   3.0%
White
11
  84.6%
19
  95.0%
30
  90.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 20 participants 33 participants
13 20 33
Site of subacromial injection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 20 participants 33 participants
Right Bursa injected 6 14 20
Left Bursa injected 7 6 13
1.Primary Outcome
Title Improvement in Shoulder Function
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone (Kenalog) Rilonacept
Hide Arm/Group Description:

A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.

Corticosteroid (Triamcinolone (Kenalog) )

160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.

Rilonacept: 160 mg intra-bursal once

Overall Number of Participants Analyzed 13 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.92  (15.40) 38.52  (25.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triamcinolone (Kenalog), Rilonacept
Comments

Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)

1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0.

Type of Statistical Test Non-Inferiority or Equivalence
Comments For details of power calculation, see above. Using a minimal clinical importance of -9.1, the null hypothesis was a mean difference less than -9.1.
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Improvement in Pain
Hide Description Secondary 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).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone (Kenalog) Rilonacept
Hide Arm/Group Description:

A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.

Corticosteroid (Triamcinolone (Kenalog) )

160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.

Rilonacept: 160 mg intra-bursal once

Overall Number of Participants Analyzed 13 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.27  (1.42) 3.85  (2.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triamcinolone (Kenalog), Rilonacept
Comments

Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)

1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0.

Type of Statistical Test Non-Inferiority or Equivalence
Comments See details above regarding effect size, power, etc.
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone (Kenalog) Rilonacept
Hide Arm/Group Description:

A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.

Corticosteroid (Triamcinolone (Kenalog) )

160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.

Rilonacept: 160 mg intra-bursal once

Overall Number of Participants Analyzed 13 20
Measure Type: Number
Unit of Measure: participants
3 8
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Triamcinolone (Kenalog) Rilonacept
Hide Arm/Group Description

A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.

Corticosteroid (Triamcinolone (Kenalog) )

160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.

Rilonacept: 160 mg intra-bursal once

All-Cause Mortality
Triamcinolone (Kenalog) Rilonacept
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Triamcinolone (Kenalog) Rilonacept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      1/20 (5.00%)    
Infections and infestations     
Hospitalization * [1]  1/12 (8.33%)  12 1/20 (5.00%)  20
*
Indicates events were collected by non-systematic assessment
[1]
One subject in the rilonacept arm was hospitalized for diarrhea, heme-occult positive stool, and an INR of 3.4. One subject in the triamcinolone arm was hospitalized for shortness of breath for which an etiology was never identified.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Triamcinolone (Kenalog) Rilonacept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      7/20 (35.00%)    
Gastrointestinal disorders     
Diarrhea *  0/13 (0.00%)  0 2/20 (10.00%)  2
Infections and infestations     
Thrush *  1/13 (7.69%)  1 0/20 (0.00%)  0
Acute Bronchitis * [1]  0/13 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
Injection Site Reaction *  1/13 (7.69%)  1 0/20 (0.00%)  0
Generalized Stiffness *  0/13 (0.00%)  0 1/20 (5.00%)  1
Hand Tingling *  0/13 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders     
Headache *  0/13 (0.00%)  0 2/20 (10.00%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Required antibiotics
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Matthew B. Carroll, MD
Organization: Keesler Medical Center
Phone: 228-376-3629
Responsible Party: Keesler Air Force Base Medical Center
ClinicalTrials.gov Identifier: NCT01830699     History of Changes
Other Study ID Numbers: FKE20120016H
First Submitted: April 6, 2013
First Posted: April 12, 2013
Results First Submitted: May 10, 2014
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014