Back to resultsProof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
Primary Purpose
Post-traumatic Osteoarthritis of the Knee
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FX006 32 mg
TCA IR 40 mg
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Osteoarthritis of the Knee focused on measuring Osteoarthritis, Post-traumatic, Knee, Pain, Corticosteroid, Intra-articular, Injection
Eligibility Criteria
Inclusion Criteria:
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Male or female ≥20 and ≤50 years of age
- Diagnosis of post-traumatic OA of the knee
- Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening
- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
- Body mass index (BMI) ≤ 40 kg/m2
- Willingness to abstain from use of restricted medications and therapies during the study
Exclusion Criteria:
- Prior osteotomy of the index knee
- Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to or greater than the index knee pain)
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
- History of, or clinical signs and symptoms of active infection of the index knee
- Crystal disease of the index knee within one month of Screening
- Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or >2mm of articular incongruity after surgery
- IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
- IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
- Any other IA investigational drug/biologic within 6 months of Screening
- Prior use of FX006
- Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period
- Type 1 or Type 2 diabetes requiring insulin
- Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Sites / Locations
- San Antonio Military Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FX006 32mg
TCA IR 40 mg
Arm Description
Single 5 mL intra-articular (IA) injection Extended-release formulation
Single 1 mL intra-articular (IA) injection Immediate-release formulation
Outcomes
Primary Outcome Measures
Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Secondary Outcome Measures
Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week
Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
WOMAC A (Pain Subscale)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
WOMAC A1 (Pain on Walking Question)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
WOMAC B (Stiffness)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
WOMAC C (Function)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
WOMAC (Total):
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Knee Injury and Osteoarthritis Score (KOOS)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12
Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12
Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12
Time to Onset of Pain Relief
Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing >30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline
Average Weekly and Total Consumption of Rescue Medication
Full Information
NCT ID
NCT02468583
First Posted
May 27, 2015
Last Updated
August 1, 2018
Sponsor
Flexion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02468583
Brief Title
Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
Official Title
A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (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
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.
Detailed Description
This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of:
32 mg of FX006
40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP)
Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Osteoarthritis of the Knee
Keywords
Osteoarthritis, Post-traumatic, Knee, Pain, Corticosteroid, Intra-articular, Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FX006 32mg
Arm Type
Experimental
Arm Description
Single 5 mL intra-articular (IA) injection Extended-release formulation
Arm Title
TCA IR 40 mg
Arm Type
Active Comparator
Arm Description
Single 1 mL intra-articular (IA) injection Immediate-release formulation
Intervention Type
Drug
Intervention Name(s)
FX006 32 mg
Other Intervention Name(s)
Zilretta
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
TCA IR 40 mg
Other Intervention Name(s)
Kenalog®-40, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Intervention Description
Comparator
Primary Outcome Measure Information:
Title
Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10
Description
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame
5-10 Weeks
Secondary Outcome Measure Information:
Title
Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12
Description
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Time Frame
12 Weeks
Title
Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Time Frame
12 Weeks
Title
Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week
Time Frame
12 Weeks
Title
Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Time Frame
12 Weeks
Title
WOMAC A (Pain Subscale)
Description
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame
12 weeks
Title
WOMAC A1 (Pain on Walking Question)
Description
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame
12 weeks
Title
WOMAC B (Stiffness)
Description
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame
12 weeks
Title
WOMAC C (Function)
Description
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame
12 weeks
Title
WOMAC (Total):
Description
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame
12 weeks
Title
Knee Injury and Osteoarthritis Score (KOOS)
Description
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Time Frame
12 weeks
Title
Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12
Time Frame
12 weeks
Title
Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12
Time Frame
12 weeks
Title
Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12
Time Frame
12 weeks
Title
Time to Onset of Pain Relief
Description
Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing >30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline
Time Frame
Baseline to >30% improvement
Title
Average Weekly and Total Consumption of Rescue Medication
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female ≥20 and ≤50 years of age
Diagnosis of post-traumatic OA of the knee
Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening
Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of restricted medications and therapies during the study
Exclusion Criteria:
Prior osteotomy of the index knee
Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to or greater than the index knee pain)
Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
History of, or clinical signs and symptoms of active infection of the index knee
Crystal disease of the index knee within one month of Screening
Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or >2mm of articular incongruity after surgery
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period
Type 1 or Type 2 diabetes requiring insulin
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Bodick, MD
Organizational Affiliation
Flexion Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
San Antonio Military Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
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