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

Completed · Phase 3

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT03529942

Run by

Pacira Pharmaceuticals, Inc

People needed

129

Starts

2018-04-24

Expected to finish

2020-03-09

Last updated by the study team

2024-01-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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