Back to resultsStudy of FX006 in Patients With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FX006
TCA IR
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee, pain, corticosteroid, intra-articular, injection
Eligibility Criteria
Main 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 >=40 years of age
- Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
- 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
Main Exclusion Criteria
- Ipsilateral hip OA
- Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
- 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)
- 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
- Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening
- 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
- Insulin-dependent diabetes
- Active psychiatric disorder including psychosis and major depressive disorder
- History of or active Cushing's syndrome
- Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
- Skin breakdown at the knee where the injection would take place
- Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
FX006 10 mg
FX006 40 mg
FX006 60 mg
TCA IR 40 mg
Arm Description
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
Single 3mL intra-articular (IA) injection Extended-Release Formulation
Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide
Outcomes
Primary Outcome Measures
Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
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."
Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
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."
Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
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
Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg
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."
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
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."
WOMAC A (Pain Subscale) Change From Baseline at Week 8
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
WOMAC B (Stiffness Subscale) Change From Baseline at Week 8
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
WOMAC C (Function Subscale) Change From Baseline at Week 8
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Percent of Responders According to OMERACT-OARSI Criteria at Week 8
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function.
Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
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."
Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
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."
Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
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."
Patient Global Impression of Change Scores at Week 8
The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Clinical Global Impression of Change Scores at Week 8
The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
Full Information
NCT ID
NCT01487161
First Posted
December 5, 2011
Last Updated
January 16, 2018
Sponsor
Flexion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01487161
Brief Title
Study of FX006 in Patients With Osteoarthritis of the Knee
Official Title
A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (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 evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.
Detailed Description
Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR.
The general tolerability of a single injection of FX006 also was assessed.
Secondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006.
The study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.
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, 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
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FX006 10 mg
Arm Type
Experimental
Arm Description
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
Arm Title
FX006 40 mg
Arm Type
Experimental
Arm Description
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
Arm Title
FX006 60 mg
Arm Type
Experimental
Arm Description
Single 3mL 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 Triamcinolone Acetonide
Intervention Type
Drug
Intervention Name(s)
FX006
Intervention Description
Single 3 mL intra-articular injection
Intervention Type
Drug
Intervention Name(s)
TCA IR
Other Intervention Name(s)
Kenalog®-40 Injection, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Intervention Description
Single 1 mL intra-articular injection
Primary Outcome Measure Information:
Title
Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
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
8 weeks
Title
Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
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
10 weeks
Title
Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
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
Secondary Outcome Measure Information:
Title
Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg
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
Weeks 8, 10 and 12
Title
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
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
Weeks 1-7 and Week 9 and 11
Title
WOMAC A (Pain Subscale) Change From Baseline at Week 8
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
8 weeks
Title
WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
8 weeks
Title
WOMAC B (Stiffness Subscale) Change From Baseline at Week 8
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
8 weeks
Title
WOMAC C (Function Subscale) Change From Baseline at Week 8
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
8 weeks
Title
Percent of Responders According to OMERACT-OARSI Criteria at Week 8
Description
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function.
Time Frame
8 weeks
Title
Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
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
8 weeks
Title
Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
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
8 weeks
Title
Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
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
8 weeks
Title
Patient Global Impression of Change Scores at Week 8
Description
The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Time Frame
Week 8
Title
Clinical Global Impression of Change Scores at Week 8
Description
The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Time Frame
8 weeks
Title
Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main 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 >=40 years of age
Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
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
Main Exclusion Criteria
Ipsilateral hip OA
Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
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)
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
Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening
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
Insulin-dependent diabetes
Active psychiatric disorder including psychosis and major depressive disorder
History of or active Cushing's syndrome
Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
Skin breakdown at the knee where the injection would take place
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, PhD
Organizational Affiliation
Flexion Therapeutics
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Broadmeadow
State/Province
New South Wales
Country
Australia
City
Kogarah
State/Province
New South Wales
Country
Australia
City
St. Leonards
State/Province
New South Wales
Country
Australia
City
Wollongong
State/Province
New South Wales
Country
Australia
City
Kippa-Ring
State/Province
Queensland
Country
Australia
City
Maroochydore
State/Province
Queensland
Country
Australia
City
Sherwood
State/Province
Queensland
Country
Australia
City
Clayton
State/Province
Victoria
Country
Australia
City
Malvern East
State/Province
Victoria
Country
Australia
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Etobicoke
State/Province
Ontario
Country
Canada
City
Newmarket
State/Province
Ontario
Country
Canada
City
Sarnia
State/Province
Ontario
Country
Canada
City
St. Catherine's
State/Province
Ontario
Country
Canada
City
Thornhill
State/Province
Ontario
Country
Canada
City
Waterloo
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Sainte-Foy
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://journals.lww.com/jbjsjournal/Abstract/2015/06030/An_Intra_Articular,_Extended_Release_Formulation.1.aspx
Description
Journal of Bone & Joint Surgery - American Volume: 3 June 2015 - Volume 97 - Issue 11 - p 877-888
Learn more about this trial
Study of FX006 in Patients With Osteoarthritis of the Knee
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