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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
Sponsor:
Information provided by (Responsible Party):
Keesler Air Force Base Medical Center

Tracking Information
First Submitted Date  ICMJE April 6, 2013
First Posted Date  ICMJE April 12, 2013
Results First Submitted Date  ICMJE May 10, 2014
Results First Posted Date  ICMJE August 4, 2014
Last Update Posted Date August 4, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2013)
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.
Change History Complete list of historical versions of study NCT01830699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2014)
  • 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 Measures  ICMJE
 (submitted: April 11, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis
Official Title  ICMJE 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 Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Subacromial Bursitis
Intervention  ICMJE
  • Drug: Rilonacept
    160 mg intra-bursal once
    Other Name: Arcalyst
  • Drug: Corticosteroid
    2 cc (40 mg/mL) triamcinolone intra-bursal once
    Other Name: Triamcinolone (Kenalog)
Study Arms  ICMJE
  • Active Comparator: Rilonacept
    160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
    Intervention: Drug: Rilonacept
  • Placebo Comparator: Corticosteroid
    80 mg (2 cc of 40 mg/mL) Kenalog intra-bursal once
    Intervention: Drug: Corticosteroid
Publications * Carroll MB, Motley SA, Wohlford S, Ramsey BC. Rilonacept in the treatment of subacromial bursitis: A randomized, non-inferiority, unblinded study versus triamcinolone acetonide. Joint Bone Spine. 2015 Dec;82(6):446-50. doi: 10.1016/j.jbspin.2015.02.009. Epub 2015 Jul 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2014)
33
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2013)
150
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01830699
Other Study ID Numbers  ICMJE FKE20120016H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keesler Air Force Base Medical Center
Study Sponsor  ICMJE Keesler Air Force Base Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew B Carroll, MD Keesler Medical Center
PRS Account Keesler Air Force Base Medical Center
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP