Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee

NCT ID: NCT03529942

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-24
• Study Completion Date: 2020-03-09

Brief Summary

This is an open-label study assessing the effect of the administration of a single intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with osteoarthritis (OA) of the knee.

Detailed Description

This is an open-label study assessing the effect of the administration of a single intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with osteoarthritis (OA) of the knee. The study will be conducted in male and female patients who are ≥ 40 years of age.

Eligible patients who provide written consent and meet all entry criteria will undergo initial ultrasound examination and MRI with contrast of the index knee, and then receive a single IA injection of FX006 administered to the index knee at Baseline/Day 1. Patients will return to the clinic at Weeks 6 and 24 for an MRI with contrast of the index knee and other assessments. Patients must also have a blood sample drawn for Estimated Glomerular Filtration Rate (eGFR) testing within 30 days prior to the scheduled MRIs. In addition, a patient questionnaire will be administered and adverse events (AEs) and concomitant medication updates will be collected via telephone at Weeks 12 and 18.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FX006 32 mg

Single intra-articular (IA) injection of FX006 32 mg

Group Type: EXPERIMENTAL

FX006 32 mg

Intervention Type: DRUG

Extended-release 32 mg FX006 IA injection

Interventions

FX006 32 mg

Extended-release 32 mg FX006 IA injection

Intervention Type: DRUG

Other Intervention Names

Zilretta

Eligibility Criteria

Inclusion Criteria

• Written consent to participate in the study
• Male or female ≥ 40 years of age
• Body mass index (BMI) ≤ 40 kg/m^2
• Ambulatory and in good general health
• Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
• Willing to abstain from use of protocol-restricted medications during the study
• Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening (patient self-report is acceptable)
• Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
• Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee based on X-ray performed during Screening (centrally read)

Exclusion Criteria

• Any inflammatory arthritis including reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, gout or secondary OA from gout
• History of infection or crystal disease in the index knee joint
• Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening
• Surgery or arthroscopy of the index knee within 12 months of Screening
• IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
• IA treatment of the index knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
• IV or 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 in the index knee 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
• eGFR results <40 mL/minute
• Any contraindication to MRI Scanning (e.g., presence of certain ferromagnetic foreign bodies or electronic devices including most cardiac pacemakers, claustrophobia)
• Known hypersensitivity to any form of radiographic contrast
• Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Kelley, MD

Role: STUDY_DIRECTOR

Flexion Therapeutics

Locations

TriWest Research Associates, LLC

El Cajon, California, United States

Biosolutions Research

La Mesa, California, United States

Dream Team Clinical Research (formerly located in Anaheim)

Pomona, California, United States

Dream Team Clinical Research

Pomona, California, United States

Tampa Bay Medical Research, Inc.

Clearwater, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Duke University Medical Center

Durham, North Carolina, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

PMG Research, Inc. d/b/a PMG Research of Knoxville

Knoxville, Tennessee, United States

University of Leeds

Leeds, , United Kingdom

Countries

United States; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FX006-2017-014

Identifier Type: -

Identifier Source: org_study_id