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

Pacira

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis, Knee

Treatments

Drug: FX006 32 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03529942

FX006-2017-014

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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