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Trial record 4 of 24 for:    RILONACEPT OR ARCALYST OR IL-1 TRAP OR INTERLEUKIN-1 TRAP

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

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).

Condition or disease Intervention/treatment Phase
Subacromial Bursitis Drug: Rilonacept Drug: Corticosteroid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis
Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bursitis Steroids
Drug Information available for: Rilonacept

Arm Intervention/treatment
Active Comparator: Rilonacept
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Drug: Rilonacept
160 mg intra-bursal once
Other Name: Arcalyst

Placebo Comparator: Corticosteroid
80 mg (2 cc of 40 mg/mL) Kenalog intra-bursal once
Drug: Corticosteroid
2 cc (40 mg/mL) triamcinolone intra-bursal once
Other Name: Triamcinolone (Kenalog)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830699


Locations
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United States, Mississippi
Keesler Medical Center
Keesler AFB, Mississippi, United States, 39534
Sponsors and Collaborators
Keesler Air Force Base Medical Center
Investigators
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Principal Investigator: Matthew B Carroll, MD Keesler Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Keesler Air Force Base Medical Center
ClinicalTrials.gov Identifier: NCT01830699     History of Changes
Other Study ID Numbers: FKE20120016H
First Posted: April 12, 2013    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014
Last Verified: July 2014

Keywords provided by Keesler Air Force Base Medical Center:
Rilonacept
Subacromial Bursitis treatment
Corticosteroid Injection

Additional relevant MeSH terms:
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Rilonacept
Bursitis
Joint Diseases
Musculoskeletal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action