Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keesler Air Force Base Medical Center
• Treatments: Rilonacept; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• At least 18 years of age or older and at a minimum have a recent history (more than 3 days worth) of shoulder pain with moderate to severe tenderness to palpation over the subacromial bursa.

Exclusion Criteria:

• Allergies to lidocaine, marcaine, or kenalog.

• Allergies to rilonacept

• Flare of active inflammatory arthritis (such as a flare of Rheumatoid Arthritis)

• Gout or Pseudogout attack of the shoulder with subacromial tenderness

• Active infection

• Actively receiving chemotherapy, radiation therapy, or anticipating surgery for neoplasia

• Active myocardial infarction

• Clinical and/or radiographic evidence of a fracture (clavicular, humeral, or other).