Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis

A Pilot Study of a Dexamethasone Implant System in Humans

The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Dexamethasone

Detailed Description

The objectives of the study are to assess the dexamethasone delivery system for:

• Safety and tolerability
• Efficacy

Formal statistical analysis to compare treatment groups will not be performed due to the small number of participants in this pilot study. Summary statistics will be assessed using the short form of the knee injury and osteoarthritis outcome score (KOOS JR) surveys and questionnaires to assess pain intensity, pain medication consumption and wound assessment.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Male or female ≥ 40 years of age at time of consent
• Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior to screening with confirmation of osteoarthritis according to the American College of Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to screening or during the screening period
• Kellgren - Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph performed within 6 months prior to or during screening period
• Mean score of ≥ 5 and ≤ 10 on the 24 hour average pain score (0 - 10 Numeric Rating System) during the screening period
• Body mass index (BMI) ≤ 40 kg/m2
• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
• Willingness to stop all pain medications except acetaminophen and paracetamol 14 days prior to implantation

Exclusion Criteria:

• Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
• History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis
• Hemophilia
• Achondroplasia
• History of infection in the index joint
• Intra-articular corticosteroid (investigational or marketed) in any joint within three months of screening
• Intra-articular hyaluronic acid (investigational or marketed) in the index knee within three months of screening
• Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one month of screening
• Prior arthroscopic or open surgery of the index knee within 12 months of screening
• Planned / anticipated surgery of the index knee during the study period
• Active or history of malignancy within the last five years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
• Insulin dependent diabetes
• History of or active Cushing's syndrome
• Skin breakdown at index knee where procedure would take place
• Women of child-bearing potential
• Case history related to motor vehicle accident or workers compensation
• Presence of hardware in the index knee (e.g. screws, plates)
• Immunocompromised patients (TB, HIV, etc.)
• Allergic reactions to acetaminophen and paracetamol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone delivery system	Drug: Dexamethasone; Sustained delivery system containing 5.0 mg of dexamethasone programmed to release an estimated 10 μg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events		Through 24 weeks
Change from baseline in weekly mean of the pain intensity score	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night	Weeks 12, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in weekly mean of the pain intensity score	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night	Weekly through 24 weeks
Time of onset of pain relief		Weekly through 24 weeks
Change from baseline in KOOS-JR score (stiffness)	Using a response scale of none, mild, moderate, severe, and extreme	Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change from baseline in KOOS-JR score (pain)	Using a response scale of none, mild, moderate, severe, and extreme	Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change from baseline in KOOS-JR score (function)	Using a response scale of none, mild, moderate, severe, and extreme	Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change in patient's global impression of scores assessed via office visits	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)	Weeks 4, 12, 24
Change in clinical observer's global impression of scores assessed via office visits	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)	Weeks 4, 12, 24
Percent of responders (defined as patients with high improvement in pain or function) according to OMERACT-OARSI criteria		Weeks 1, 2, 4, 8, 12, 24
Average weekly consumption of rescue medications		Through 24 weeks
Average total consumption of rescue medications		Through 24 weeks

Collaborators and Investigators

• Sponsor: Mark Figgie
• Collaborators: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Mark Figgie, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2016
• Primary Completion (Actual): September 21, 2017
• Study Completion (Actual): September 21, 2017

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 2015-523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No