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

NCT02003365 | Completed Phase 2 Results

• 1 other identifier: FX006-2013-005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; corticosteroids; triamcinolone acetonide; synovial fluid

Outcome Measures

Primary Outcomes (1)

• Concentration of Triamcinolone Acetonide in Synovial Fluid

  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).

  12 to 20 weeks

Secondary Outcomes (1)

• Plasma Drug Concentrations by Time

  Weeks 6, 12, 16 and 20

Study Arms (3)

FX006 10 mg

EXPERIMENTAL

Single 3 mL intra-articular (IA) injection

Drug: FX006 10 mg

FX006 40 mg

EXPERIMENTAL

Single 3 mL intra-articular (IA) injection

Drug: FX006 40 mg

TCA IR 40 mg

ACTIVE COMPARATOR

Single 1 mL intra-articular (IA) injection

Drug: TCA IR 40 mg

Interventions

FX006 10 mg DRUG

Extended-release formulation

FX006 10 mg

FX006 40 mg DRUG

Extended-release formulation

FX006 40 mg

TCA IR 40 mg DRUG

Immediate-release formulation

Also known as: Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)

TCA IR 40 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (3)

Unknown Facility

Paducah, Kentucky, 42003, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

FX006

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Scott Kelley, VP of Medical Affairs
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Neil Bodick, MD

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 24, 2024
• Results First Posted: January 12, 2018

Record last verified: 2024-01

Locations

US (3)