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

Osteoarthritis, Knee Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Inflammation
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT03529942
• Study type: Interventional
• Source: Pacira Pharmaceuticals, Inc
• Status: Completed
• Phase: Phase 3
• Start date: April 24, 2018
• Completion date: March 9, 2020