Skip to main content
OpenTrials
Completed

NCT Number: NCT01830699

Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subacromial Bursitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keesler Medical Center

Keesler Air Force Base, Mississippi, 39534, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rilonacept

Drug

160 mg intra-bursal once

Other names: Arcalyst

Corticosteroid

Drug

2 cc (40 mg/mL) triamcinolone intra-bursal once

Other names: Triamcinolone (Kenalog)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Keesler Air Force Base Medical Center

Fed

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 12, 2013
Registry last updated
Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.