Clinical Trial: Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

Brief Summary: To date no trials have been performed looking at whether or not intra-bursal injection of an IL-1 antagonist provides pain relief similar to that of a corticosteroid injection. The subcutaneous injection of anakinra, an IL-1 receptor antagonist, in patients with shoulder pain due to rotator cuff tendonitis and subacromial bursitis was efficacious in relieving pain but this information was presented as a case series in a letter to the editor format, so the validity of these results would require additional testing [Omoigui S, et al. 2004]. Based mainly on the data from the intra-articular administration of anakinra, there have not been any adverse trends in outcomes or safety to suggest that intra-bursal injection of rilonacept will carry an increase risk of adverse events. The purpose of this trial is to compare the improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis of rilonacept vs. corticosteroid injection (standard of care).

Detailed Summary:

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.

Current Primary Outcome: Improvement in Shoulder Function [ Time Frame: 4 weeks ]

Original Primary Outcome: Improvement in Shoulder Function [ Time Frame: 4 weeks ]

Current Secondary Outcome:

• 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.

Original Secondary Outcome:

• Improvement in Pain [ Time Frame: 4 weeks ]
  Secondary outcomes are improvement in pain (as assessed by a visual analogue score between 0 and 10, with 0 as no pain and 10 as severe pain).
• Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 years ]
  Any adverse event reported by the study participant during the four trial in either arm will be recorded.

Dates:
Date Received: April 6, 2013
Date Started: March 2013
Date Completion:
Last Updated: July 13, 2014
Last Verified: July 2014