Clinical trial NCT03529942: Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee
Official title: An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee
Pain
Intra-articular
Injection
Corticosteroid
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2018-05-18
Enrollment: 129
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Standardized Change in Synovial Volume (SV) at 6 Weeks
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Mean Absolute Change in Synovial Volume at 6 Weeks
timeFrame: Baseline to Week 6
measure: Mean Standardized Change in Synovial Volume (SV) at 24 Weeks
timeFrame: Baseline to Week 24
measure: Mean Absolute Change in Synovial Volume at 24 Weeks
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: La Mesa
country: United States
facility: Biosolutions Research
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research (formerly located in Anaheim)
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Knoxville
country: United States
facility: PMG Research, Inc. d/b/a PMG Research of Knoxville
state: Tennessee
city: Leeds
country: United Kingdom
facility: University of Leeds
Study officials:
affiliation: Flexion Therapeutics
name: Scott Kelley, MD
role: STUDY_DIRECTOR
References: