Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FX006 10 mg
FX006 40 mg
TCA IR 40 mg
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee, corticosteroids, triamcinolone acetonide, synovial fluid
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
FX006 10 mg
FX006 40 mg
TCA IR 40 mg
Arm Description
Single 3 mL intra-articular (IA) injection
Single 3 mL intra-articular (IA) injection
Single 1 mL intra-articular (IA) injection
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Plasma Drug Concentrations by Time
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).
Full Information
NCT ID
NCT02003365
First Posted
November 18, 2013
Last Updated
December 13, 2017
Sponsor
Flexion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02003365
Brief Title
Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee
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 Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flexion Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis, knee, corticosteroids, triamcinolone acetonide, synovial fluid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FX006 10 mg
Arm Type
Experimental
Arm Description
Single 3 mL intra-articular (IA) injection
Arm Title
FX006 40 mg
Arm Type
Experimental
Arm Description
Single 3 mL intra-articular (IA) injection
Arm Title
TCA IR 40 mg
Arm Type
Active Comparator
Arm Description
Single 1 mL intra-articular (IA) injection
Intervention Type
Drug
Intervention Name(s)
FX006 10 mg
Intervention Description
Extended-release formulation
Intervention Type
Drug
Intervention Name(s)
FX006 40 mg
Intervention Description
Extended-release formulation
Intervention Type
Drug
Intervention Name(s)
TCA IR 40 mg
Other Intervention Name(s)
Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Intervention Description
Immediate-release formulation
Primary Outcome Measure Information:
Title
Concentration of Triamcinolone Acetonide in Synovial Fluid
Description
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).
Time Frame
12 to 20 weeks
Secondary Outcome Measure Information:
Title
Plasma Drug Concentrations by Time
Description
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).
Time Frame
Weeks 6, 12, 16 and 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Bodick, MD
Organizational Affiliation
Flexion Therapeutics
Official's Role
Study Director
Facility Information:
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee
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