N/A
N=33
Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis
Subacromial Bursitis
Bottom Line
View on ClinicalTrials.gov: NCT01830699 ↗Enrolled (actual)
33
Serious AEs
6.3%
Results posted
Aug 2014
Primary outcome: Primary: Improvement in Shoulder Function — 15.92; 38.52 units on a scale — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rilonacept (Drug); Corticosteroid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Keesler Air Force Base Medical Center
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Shoulder Function |
15.92; 38.52 | 0.004 sig |
| SECONDARY Improvement in Pain |
2.27; 3.85 | 0.044 sig |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
3; 8 | — |
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).
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01830699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.