Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee

NCT03046446 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FX006-2016-011
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 17

Brief Summary

This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; Knee; Pain; Steroid; Intra-articular; Injection

Outcome Measures

Primary Outcomes (1)

• Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006

  Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE) in patients who received two doses of 32 mg FX006. TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).

  Up to 52 Weeks

Other Outcomes (4)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Subscale

  12 Weeks Post Each FX006 Administration

• WOMAC B Stiffness Subscale

  12 Weeks Post Each FX006 Administration

• WOMAC C Function Subscale

  12 Weeks Post Each FX006 Administration

Study Arms (1)

FX006 32 mg

EXPERIMENTAL

Single intra-articular injection

Drug: FX006 32 mg

Interventions

FX006 32 mg DRUG

Single intra-articular injection

FX006 32 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent to participate in the study
• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
• Male or female ≥ 40 years of age
• Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening
• Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
• Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the index knee based on X-ray performed during Screening
• Qualifying score for WOMAC A at Screening and Day 1/Baseline
• Index knee pain for \>15 days over the last month (as reported by the patient)
• Body mass index (BMI) ≤ 40 kg/m2
• Ambulatory and in good general health
• Willingness to abstain from use of protocol-restricted medications during the study

You may not qualify if:

• Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
• History of infection in the index knee joint
• Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
• Presence of surgical hardware or other foreign body in the index knee
• Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening
• IA corticosteroid (investigational or marketed) in index knee within 3 months of Screening
• IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
• Oral corticosteroids (investigational or marketed) within 1 month of Screening
• Any other IA drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy and amniotic fluid injection)
• Prior administration of FX006
• Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (17)

Tucson Orthopedic

Tucson, Arizona, 85712, United States

Location

Dream Team Clinical Research

Anaheim, California, 92801, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 37761, United States

Location

The Andrews Institute

Gulf Breeze, Florida, 32561, United States

Location

Ochsner Sports Medicine Institute

New Orleans, Louisiana, 70121, United States

Location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

New England Baptist Hospital

Dedham, Massachusetts, 02026, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

PMG Research of Knoxville

Knoxville, Tennessee, 37938, United States

Location

Related Publications (1)

• Spitzer AI, Richmond JC, Kraus VB, Gomoll A, Jones DG, Huffman KM, Peterfy C, Cinar A, Lufkin J, Kelley SD. Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. Rheumatol Ther. 2019 Mar;6(1):109-124. doi: 10.1007/s40744-019-0140-z. Epub 2019 Feb 11.

  PMID: 30741382 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

FX006

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Disease progression defined as response to first and second injections but loss of effect sometime after the response to the second injection. All discontinuations because of disease progression occurred ≥ 12 weeks after the second injection.

Results Point of Contact

• Title: Scott Kelley, Chief Medical Officer
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Scott Kelley, MD

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 8, 2017
• Study Start: February 20, 2017
• Primary Completion: July 19, 2018
• Study Completion: July 19, 2018
• Last Updated: January 24, 2024
• Results First Posted: October 29, 2019

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)