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

Completed · Phase 3

Conditions studied: Osteoarthritis of the Knee

In brief

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

Key facts

Study ID

NCT03046446

Run by

Pacira Pharmaceuticals, Inc

People needed

208

Starts

2017-02-20

Expected to finish

2018-07-19

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
• 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

Where it is running

• Tucson Orthopedic — Tucson, Arizona, United States
• Dream Team Clinical Research — Anaheim, California, United States
• Hope Clinical Research — Canoga Park, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• The Andrews Institute — Gulf Breeze, Florida, United States
• Ochsner Sports Medicine Institute — New Orleans, Louisiana, United States
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
• New England Baptist Hospital — Dedham, Massachusetts, United States
• Rochester Clinical Research — Rochester, New York, United States
• Duke University — Durham, North Carolina, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• PMG Research of Knoxville — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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