Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

Bilateral Knee Osteoarthritis Clinical Trial

Official title:

A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378076
• Other study ID #: FX006-2017-012
• Status: Completed
• Phase: Phase 2
• Start date: December 6, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: January 2024
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Description:

This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA.

Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with IA injections to both knees of either:

• extended-release FX006 64 mg total dose (approximately 12 patients) or

• immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on Day 1. Following screening, pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 8, 15, 29, and 43.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 14, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Written consent to participate in the study

• Male or female greater than or equal to 40 years of age

• Symptoms consistent with OA in both knees for greater than or equal to 6 months prior to Screening (patient reported is acceptable)

• Currently meets ACR Criteria (clinical and radiological) for OA in both knees

• Knee pain in both knees for greater than 15 days over the last month (as reported by the patient)

• Body mass index (BMI) less than or equal to 40 kg/m2

• Morning serum cortisol result within normal range at Screening (5-23 mcg/dL or 138-635 nmol/dL)

• 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

Exclusion Criteria:

• Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease

• History of infection in either knee joint

• Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening

• Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12 months of Screening

• Presence of surgical hardware or other foreign body in either knee

• Surgery or arthroscopy of either knee within 12 months of Screening

• IA treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).

• IA treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening

• Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening

• Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening

• Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

Related Conditions & MeSH terms

• Bilateral Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• FX006 32 mg
Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)
• TAcs 40 mg
Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)

Locations

Country	Name	City	State
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Rochester Clinical Research	Rochester	New York
United States	LA Biomed at Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma	Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma.; For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations	43 days
Primary	Incidence of Treatment Emergent Adverse Events	Safety analyses were conducted using the safety population.; Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE).	43 days