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
|Condition or disease||Intervention/treatment||Phase|
|Subacromial Bursitis||Drug: Rilonacept Drug: Corticosteroid||Not Applicable|
Background: Subacromial bursitis is an inflammatory condition which is typically triggered by altered rotator cuff mechanics. One of the mainstays of therapy is corticosteroid injection. Given the inflammatory nature of subacromial bursitis coupled with prominence of interleukin-1 (IL-1) beta on histopathologic assessment of resected subacromial bursa, targeted anti-IL-1 therapy would be an attractive alternative to corticosteroid injection.
Hypothesis: One intra-bursal injection of the IL-1 trap rilonacept (Arcalyst ®), currently FDA approved for the treatment of cryopyrin associated periodic syndrome (CAPS), is non-inferior to intra-bursal corticosteroid injection at 4 weeks post-procedure.
Methods: This study is a prospective trial lasting a total of 4 weeks. Patients with typical symptoms and signs of subacromial bursitis are randomized to either corticosteroid injection prepared in the usual fashion in clinic vs. injection of rilonacept. Prior to injection of either medication patients will complete a QuickDASH Questionnaire and provide a verbal pain score from 0 to 10. The Quick DASH Questionnaire and verbal pain score are then completed within 2 duty days of injection, 2 weeks after injection, and 4 weeks after injection by phone.
Primary Outcome: Primary outcome is improvement in QuickDASH. Secondary outcomes are improvement in the verbal pain score and monitoring for infection or other complications from rilonacept administration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Active Comparator: Rilonacept
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
160 mg intra-bursal once
Other Name: Arcalyst
Placebo Comparator: Corticosteroid
80 mg (2 cc of 40 mg/mL) Kenalog intra-bursal once
2 cc (40 mg/mL) triamcinolone intra-bursal once
Other Name: Triamcinolone (Kenalog)
- Improvement in Shoulder Function [ Time Frame: 4 weeks ]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.
- Improvement in Pain [ Time Frame: 4 weeks ]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).
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 weeks ]Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830699
|United States, Mississippi|
|Keesler Medical Center|
|Keesler AFB, Mississippi, United States, 39534|
|Principal Investigator:||Matthew B Carroll, MD||Keesler Medical Center|