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

• ClinicalTrials.gov Identifier: NCT02003365
• Recruitment Status: Completed
• First Posted: December 6, 2013
• Results First Posted: January 12, 2018
• Last Update Posted: January 12, 2018
• Sponsor: Flexion Therapeutics, Inc.
• Information provided by (Responsible Party): Flexion Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis of the Knee	Drug: FX006 10 mg; Drug: FX006 40 mg; Drug: TCA IR 40 mg	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee
• Study Start Date: November 2013
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: FX006 10 mg; Single 3 mL intra-articular (IA) injection	Drug: FX006 10 mg; Extended-release formulation
Experimental: FX006 40 mg; Single 3 mL intra-articular (IA) injection	Drug: FX006 40 mg; Extended-release formulation
Active Comparator: TCA IR 40 mg; Single 1 mL intra-articular (IA) injection	Drug: TCA IR 40 mg; Immediate-release formulation; Other Names: Kenalog®-40 Injection; Triamcinolone Acetonide Crystalline Suspension (TAcs)

Outcome Measures

Primary Outcome Measures :

1. Concentration of Triamcinolone Acetonide in Synovial Fluid [ Time Frame: 12 to 20 weeks ]

   Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population.

   Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).

Secondary Outcome Measures :

1. Plasma Drug Concentrations by Time [ Time Frame: Weeks 6, 12, 16 and 20 ]

   Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population.

   Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ).

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key 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

Key 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

Contacts and Locations

Locations

United States, Kentucky

Paducah, Kentucky, United States, 42003

United States, Pennsylvania

Duncansville, Pennsylvania, United States, 16635

United States, Texas

Dallas, Texas, United States, 75231

Sponsors and Collaborators

Flexion Therapeutics, Inc.

Investigators

• Study Director: Neil Bodick, MD; Flexion Therapeutics

More Information

• Responsible Party: Flexion Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02003365
• Other Study ID Numbers: FX006-2013-005
• First Posted: December 6, 2013
• Results First Posted: January 12, 2018
• Last Update Posted: January 12, 2018
• Last Verified: December 2017

Keywords provided by Flexion Therapeutics, Inc.:

osteoarthritis; knee; corticosteroids; triamcinolone acetonide; synovial fluid

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; FX006; Triamcinolone diacetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action