Study of FX006 in Patients With Osteoarthritis of the Knee | NCT01487161

NCT01487161

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FX006 10 mg	Experimental	Single 3 mL intra-articular (IA) injection Extended-Release Formulation	Drug: FX006
FX006 40 mg	Experimental	Single 3 mL intra-articular (IA) injection Extended-Release Formulation	Drug: FX006
FX006 60 mg	Experimental	Single 3mL intra-articular (IA) injection Extended-Release Formulation	Drug: FX006
TCA IR 40 mg	Active Comparator	Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide	Drug: TCA IR

Name	Type	Description	Arm Group Labels	Other Names
FX006	Drug	Single 3 mL intra-articular injection	FX006 10 mg FX006 40 mg FX006 60 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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."	8 weeks
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."	10 weeks
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."	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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."	Weeks 8, 10 and 12

Eligibility Module

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

Contacts/Locations Module

Name	Affiliation	Role
Neil Bodick, MD, PhD	Flexion Therapeutics	Study Director

References Module

Label	URL
Journal of Bone \& Joint Surgery - American Volume: 3 June 2015 - Volume 97 - Issue 11 - p 877-888	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	FX006 10 mg	58 subjects received FX006 10 mg as a single 3 mL IA injection.
FG001	FX006 40 mg	59 subjects received FX006 40 mg as a single 3 mL IA injection.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

A total of 229 patients were randomized to treatment in this study. 228 of 229 randomized patients received treatment and were included in the Safety Population; 1 patient randomized to the TCA IR group withdrew consent before receiving study treatment and was excluded.

Arm/Group Information

ID	Title	Description
BG000	FX006 10 mg	Single 3 mL IA injection
BG001	FX006 40 mg	Single 3 mL IA injection
BG002	FX006 60 mg	Single 3 mL IA injection
BG003	TCA IR (40 mg)	Single 1 mL IA injection
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	OG000-3.9± 0.28 OG001-3.4± 0.31

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Longitudinal mixed effect model		0.1249		Mean Difference (Final Values)	-0.5			2-Sided	90	-1.2	0.2					Superiority

Primary

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."

All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.

Posted

Least Squares Mean

Standard Error

units on a scale

10 weeks

ID	Title	Description
OG000	FX006 60 mg	FX006: Single 3 mL IA injection
OG001	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Units	Counts
Participants	OG000

Primary

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."

All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.

Posted

Least Squares Mean

Standard Error

units on a scale

12 weeks

ID	Title	Description
OG000	FX006 60 mg	FX006: Single 3 mL IA injection
OG001	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Units	Counts
Participants	OG000

Secondary

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."

All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.

Posted

Least Squares Mean

Standard Error

units on a scale

Weeks 8, 10 and 12

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Units	Counts
Participants

Secondary

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."

All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.

Posted

Least Squares Mean

Standard Error

units on a scale

Weeks 1-7 and Week 9 and 11

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Secondary

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.

Posted

Least Squares Mean

Standard Error

units on a scale

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Secondary

WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8

Posted

Least Squares Mean

Standard Error

units on a scale

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	FX006: Single 1 mL IA injection

Secondary

WOMAC B (Stiffness Subscale) Change From Baseline at Week 8

Posted

Least Squares Mean

Standard Error

units on a scale

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR (40 mg)	TCA IR: Single 1 mL IA injection

Secondary

WOMAC C (Function Subscale) Change From Baseline at Week 8

Posted

Least Squares Mean

Standard Error

units on a scale

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Secondary

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.

Posted

Count of Participants

Participants

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Units	Counts
Participants

Secondary

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."

Posted

Count of Participants

Participants

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Units	Counts
Participants

Secondary

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."

Posted

Count of Participants

Participants

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Units	Counts
Participants

Secondary

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."

Posted

Count of Participants

Participants

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Units	Counts
Participants

Secondary

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.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 8

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Secondary

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.

Posted

Least Squares Mean

Standard Deviation

units on a scale

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Secondary

Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.

Posted

Least Squares Mean

Standard Error

tablets (1tablet= 500 mg)

8 weeks

ID	Title	Description
OG000	FX006 10 mg	FX006: Single 3 mL IA injection
OG001	FX006 40 mg	FX006: Single 3 mL IA injection
OG002	FX006 60 mg	FX006: Single 3 mL IA injection
OG003	TCA IR 40 mg	TCA IR: Single 1 mL IA injection

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FX006 10 mg	FX006: Single 3 mL IA injection	58	0	58	13	58
EG001	FX006 40 mg	FX006: Single 3 mL IA injection	59	2	59	16	59
EG002	FX006 60 mg	FX006: Single 3 mL IA injection	60	1	60	22	60
EG003	TCA IR (40 mg)	TCA IR: Single 1 mL IA injection	51	0	51	22	51

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary Artery Stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected58 at risk EG0011 events1 affected59 at risk EG0020 events0 affected60 at risk EG0030 events0 affected51 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected58 at risk EG0011 events1 affected59 at risk EG0020 events0 affected60 at risk EG003
Subcutaneous Abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected58 at risk EG0010 events0 affected59 at risk EG0021 events1 affected60 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngits	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected58 at risk EG0012 events2 affected59 at risk EG0020 events0 affected60 at risk EG0033 events3 affected51 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected58 at risk EG0010 events0 affected59 at risk EG0027 events7 affected60 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected58 at risk EG0010 events0 affected59 at risk EG0023 events3 affected60 at risk EG003
Blood Glucose Increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected58 at risk EG0011 events1 affected59 at risk EG0023 events3 affected60 at risk EG003
Neutrophil Count Increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected58 at risk EG0010 events0 affected59 at risk EG0021 events1 affected60 at risk EG003
White Blood Cell Count Inreased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected58 at risk EG0010 events0 affected59 at risk EG0020 events0 affected60 at risk EG003
Arthalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 events5 affected58 at risk EG0018 events8 affected59 at risk EG0024 events4 affected60 at risk EG003
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected58 at risk EG0010 events0 affected59 at risk EG0022 events2 affected60 at risk EG003
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected58 at risk EG0015 events5 affected59 at risk EG0022 events2 affected60 at risk EG003

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis
D010146	Pain

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000631825	FX006
D014222	Triamcinolone Acetonide

OG00057
OG00159
OG00259
OG00346

Units	Counts
Participants	OG00058 OG00159 OG00260 OG00348

Units	Counts
Participants	OG00058 OG00159 OG00260 OG00348

Title	Measurements
	OG000-3.6± 0.27 OG001-3.9± 0.27 OG002-3.8± 0.27 OG003-3.5± 0.29

Title	Measurements
	OG000-3.7± 0.27 OG001-4.1± 0.27 OG002-4.2± 0.27 OG003-3.5± 0.29

Title	Measurements
	OG000-3.8± 0.26 OG001-4.3± 0.26 OG002-4.2± 0.26 OG003-3.7± 0.28

Title	Measurements
	OG000-3.9± 0.28 OG001-4.3± 0.27 OG002-4.2± 0.27 OG003-3.5± 0.30

Title	Measurements
	OG000-4.0± 0.28 OG001-4.3± 0.28 OG002-4.2± 0.28 OG003-3.4± 0.30

Title	Measurements
	OG000-3.9± 0.28 OG001-4.4± 0.28 OG002-3.9± 0.27 OG003-3.3± 0.30

Title	Measurements
	OG000-3.8± 0.30 OG001-4.2± 0.30 OG002-3.7± 0.29 OG003-3.3± 0.32

Title	Measurements
	OG000-3.7± 0.30 OG001-3.9± 0.30 OG002-3.2± 0.29 OG003-3.4± 0.32

Facility	Status	City	State	ZIP	Country	Contacts
		Tucson	Arizona	85704	United States

ID	Term
D014221	Triamcinolone
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated