Clinical trial NCT03046446: Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee
Official title: An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Knee
Pain
Steroid
Intra-articular
Injection
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2017-02-08
Enrollment: 208
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 to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee

Detailed description: This study is an open-label, repeat administration design of 32 mg FX006. The study will be conducted in male and female patients ≥ 40 years of age with symptomatic OA of the knee.

Eligible patients will be offered participation to receive an initial intra-articular (IA) injection of FX006 administered to the index knee at Day 1.

Patients who receive an initial injection of FX006 will return at Weeks 4 and 8 before being evaluated at 12, 16, 20 and 24 weeks for repeat administration. At the first evaluation where the patient has been determined to meet repeat administration eligibility criteria, the patient will be eligible to receive a second IA injection of FX006.

Patients who are eligible to receive a second injection will be evaluated for a total of 52 weeks post initial injection at: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52, regardless of the time at which they receive their second injection. In addition, X-rays will be completed at Screening and Week 52 or End of Study (EOS) for assessment of safety.

Patients that do not benefit from the initial treatment as determined by evaluation at Week 12 will complete the study at the Week 12 follow-up visit.

Patients who are not eligible for a second injection of FX006 after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 follow-up visit.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006
timeFrame: Up to 52 Weeks
Secondary outcomes:
Other outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Subscale
timeFrame: 12 Weeks Post Each FX006 Administration
measure: WOMAC B Stiffness Subscale
timeFrame: 12 Weeks Post Each FX006 Administration
measure: WOMAC C Function Subscale
timeFrame: 12 Weeks Post Each FX006 Administration
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) QOL Subscale
timeFrame: Up to 12 Weeks Post Each FX006 Administration
Locations:
city: Tucson
country: United States
facility: Tucson Orthopedic
state: Arizona
city: Anaheim
country: United States
facility: Dream Team Clinical Research
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Gulf Breeze
country: United States
facility: The Andrews Institute
state: Florida
city: New Orleans
country: United States
facility: Ochsner Sports Medicine Institute
state: Louisiana
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Dedham
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
Study officials:
affiliation: Flexion Therapeutics
name: Scott Kelley, MD
role: STUDY_DIRECTOR
References:
citation: Spitzer AI, Richmond JC, Kraus VB, Gomoll A, Jones DG, Huffman KM, Peterfy C, Cinar A, Lufkin J, Kelley SD. Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. Rheumatol Ther. 2019 Mar;6(1):109-124. doi: 10.1007/s40744-019-0140-z. Epub 2019 Feb 11.