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NCT01830699 · ClinicalTrials.gov registry record · NA
Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis
A NA study of Subacromial Bursitis, sponsored by Keesler Air Force Base Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT01830699: Completed NA study of Subacromial Bursitis, sponsored by Keesler Air Force Base Medical Center.
NCT01830699 is a NA study of Subacromial Bursitis that has completed, run by Keesler Air Force Base Medical Center. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01830699, a NA study of Subacromial Bursitis, has completed, sponsored by Keesler Air Force Base Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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 - 4
Conditions Studied
Interventions
- DRUG Corticosteroid
- DRUG Rilonacept
Study Locations (1)
Mississippi
- Keesler Medical Center - Keesler Air Force Base
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-03 |
| Phase | NA |
What the finished NCT01830699 record still lists
NCT01830699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Subacromial Bursitis appearing as the primary indexed condition, and to 2 interventions - of which Corticosteroid is the first listed.
NCT01830699 reports a single indexed study location in Mississippi.
Frequently Asked Questions
What is clinical trial NCT01830699 about?
NCT01830699 is a clinical study titled "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 ten...
What is the current status of trial NCT01830699?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2013-03. Estimated completion is 2014-03.
What conditions does trial NCT01830699 study?
This clinical trial studies the following conditions: Subacromial Bursitis.
What interventions are being tested in trial NCT01830699?
The interventions under investigation include: Corticosteroid (DRUG), Rilonacept (DRUG).
Who is sponsoring clinical trial NCT01830699?
This trial is sponsored by Keesler Air Force Base Medical Center, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01830699 being conducted?
This trial has 1 study location across Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01830699's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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