NCT03529942

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

An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	FX006 32 mg	Extended-release 32 mg FX006 IA injection

Timeline

• Start date: 2018-04-24
• Primary completion: 2019-11-08
• Completion: 2020-03-09
• First posted: 2018-05-18
• Last updated: 2024-01-24
• Results posted: 2020-12-08

Locations

10 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study