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

NCT ID: NCT03046446

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2018-07-19

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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FX006 32 mg

Single intra-articular injection

Group Type: EXPERIMENTAL

FX006 32 mg

Intervention Type: DRUG

Single intra-articular injection

Interventions

FX006 32 mg

Single intra-articular injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Kelley, MD

Role: STUDY_DIRECTOR

Flexion Therapeutics

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30741382 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FX006-2016-011

Identifier Type: -

Identifier Source: org_study_id