Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

NCT ID: NCT02003365

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-04-30

Brief Summary

The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Detailed Description

This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee.

Patients were enrolled sequentially with 8 patients per cohort, as follows:

Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12

Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.

Conditions

Osteoarthritis of the Knee

Study Design

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

Study Groups

FX006 10 mg

Single 3 mL intra-articular (IA) injection

Group Type: EXPERIMENTAL

FX006 10 mg

Intervention Type: DRUG

Extended-release formulation

FX006 40 mg

Single 3 mL intra-articular (IA) injection

Group Type: EXPERIMENTAL

FX006 40 mg

Intervention Type: DRUG

Extended-release formulation

TCA IR 40 mg

Single 1 mL intra-articular (IA) injection

Group Type: ACTIVE_COMPARATOR

TCA IR 40 mg

Intervention Type: DRUG

Immediate-release formulation

Interventions

FX006 10 mg

Extended-release formulation

Intervention Type: DRUG

FX006 40 mg

Extended-release formulation

Intervention Type: DRUG

TCA IR 40 mg

Immediate-release formulation

Intervention Type: DRUG

Other Intervention Names

Kenalog®-40 Injection; Triamcinolone Acetonide Crystalline Suspension (TAcs)

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
• Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
• Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
• Index knee pain for >15 days over the last month
• Body mass index (BMI) ≤ 40 kg/m2
• Ambulatory and in good general health

Exclusion Criteria

• History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
• History of arthritides due to crystals (e.g., gout, pseudogout)
• History of infection in the index joint
• Clinical signs and symptoms of active knee infection or crystal disease of the index knee
• Presence of surgical hardware or other foreign body in the index knee
• Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening
• IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
• IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• Oral corticosteroids (investigational or marketed) within 1 month of Screening
• Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
• Any other IA investigational drug/biologic within 6 months of Screening
• Prior use of FX006
• Prior arthroscopic or open surgery of the index knee within 12 months of Screening
• Planned/anticipated surgery of the index knee during the study period
• Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ

• 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

Neil Bodick, MD

Role: STUDY_DIRECTOR

Flexion Therapeutics

Locations

Paducah, Kentucky, United States

Duncansville, Pennsylvania, United States

Dallas, Texas, United States

Countries

United States

Other Identifiers

FX006-2013-005

Identifier Type: -

Identifier Source: org_study_id