- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01830699
Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Mississippi
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Keesler AFB, Mississippi, United States, 39534
- Keesler Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Rilonacept
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
|
160 mg intra-bursal once
Other Names:
|
PLACEBO_COMPARATOR: Corticosteroid
80 mg (2 cc of 40 mg/mL) Kenalog intra-bursal once
|
2 cc (40 mg/mL) triamcinolone intra-bursal once
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FKE20120016H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subacromial Bursitis
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Mackay Memorial HospitalCompleted
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Shin Kong Wu Ho-Su Memorial HospitalNational Science Council, TaiwanCompletedSubacromial Impingement Syndrome | Rehabilitation | Physical Therapy | Subacromial Bursitis | Therapeutic ExerciseTaiwan
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Keesler Air Force Base Medical CenterCompletedShoulder Pain | Subacromial BursitisUnited States
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Shin Kong Wu Ho-Su Memorial HospitalMinistry of Science and Technology, TaiwanCompletedShoulder Pain | Subdeltoid Bursitis | Subacromial BursitisTaiwan
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Madigan Army Medical CenterWithdrawnSubacromial Impingement Syndrome | Subacromial Bursitis
-
Benha UniversityUnknownSubdeltoid Bursitis | Subacromial BursitisEgypt
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Universidad Autonoma de Nuevo LeonCompletedSubacromial Impingement Syndrome | Rotator Cuff Impingement Syndrome | Subacromial BursitisMexico
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Linkoeping UniversityUniversity Hospital, Linkoeping; Ostergotland County Council, SwedenCompletedShoulder Impingement Syndrome | Shoulder Pain | Subacromial Bursitis | Disorder of Rotator CuffSweden
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Cerimon PharmaceuticalsPPDCompletedRotator Cuff Tendonitis | Bicipital Tendonitis | Subdeltoid Bursitis of the Shoulder | Subacromial Bursitis of the Shoulder | Medial Epicondylitis of the Elbow | Lateral Epicondylitis of the Elbow | DeQuervain's Tenosynovitis of the WristUnited States
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