Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

NCT01830699 | Completed Results DMC

• 1 other identifier: FKE20120016H
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Subacromial Bursitis

Keywords

Rilonacept; Subacromial Bursitis treatment; Corticosteroid Injection

Outcome Measures

Primary Outcomes (1)

• Improvement in Shoulder Function

  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 Outcomes (2)

• Improvement in Pain

  4 weeks

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  4 weeks

Study Arms (2)

Rilonacept

ACTIVE COMPARATOR

160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.

Drug: Rilonacept

Corticosteroid

PLACEBO COMPARATOR

80 mg (2 cc of 40 mg/mL) Kenalog intra-bursal once

Drug: Corticosteroid

Interventions

Rilonacept DRUG

160 mg intra-bursal once

Also known as: Arcalyst

Rilonacept

Corticosteroid DRUG

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

Also known as: Triamcinolone (Kenalog)

Corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Keesler Air Force Base Medical Center: lead

Study Sites (1)

Keesler Medical Center

Keesler Air Force Base, Mississippi, 39534, United States

Location

Related Publications (1)

• 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.

  PMID: 26184525 DERIVED

MeSH Terms

Interventions

rilonacept; Adrenal Cortex Hormones; Triamcinolone; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Matthew B. Carroll, MD
• Organization: Keesler Medical Center

matthew.carroll.1@us.af.mil

228-376-3629

Study Officials

• Matthew B Carroll, MD

  Keesler Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2013
• First Posted: April 12, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 4, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-07

Locations

US (1)