Trial Outcomes & Findings for Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee (NCT NCT03529942)
NCT ID: NCT03529942
Last Updated: 2024-01-24
Results Overview
Synovial volume (mm\^3) as measured by MRI and read by a central imaging vendor. Standardization was performed by dividing the model-derived least squares means and corresponding confidence intervals by the adjusted standard deviation (SD). Therefore, the mean standardized change represents the change in synovial volume expressed in standard deviation units.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
Baseline to Week 6
Results posted on
2024-01-24
Participant Flow
Participant milestones
| Measure |
FX006 32mg
All patients who received any amount of FX006 32mg
|
|---|---|
|
Overall Study
STARTED
|
129
|
|
Overall Study
Reached Week 6 With Paired MRI
|
108
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
FX006 32mg
All patients who received any amount of FX006 32mg
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Needle inserted but no drug administered
|
1
|
|
Overall Study
Personal reasons
|
1
|
Baseline Characteristics
Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee
Baseline characteristics by cohort
| Measure |
Total Population
n=129 Participants
All patients who received any amount of FX006 32mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Participants with pre-treatment synovial volume measurement as determined by quantitative image analysis, as well as a quality Week 6 MRI who received a single intra-articular (IA) injection of FX006 32 mg
Synovial volume (mm\^3) as measured by MRI and read by a central imaging vendor. Standardization was performed by dividing the model-derived least squares means and corresponding confidence intervals by the adjusted standard deviation (SD). Therefore, the mean standardized change represents the change in synovial volume expressed in standard deviation units.
Outcome measures
| Measure |
Total Population
n=108 Participants
All patients who received a single intra-articular (IA) injection of FX006 32mg and had a pre-treatment synovial volume measurement
|
Patients With Baseline Synovitis
n=84 Participants
The subset of the Total Population who had a pre-treatment synovial volume measurement of greater than 3000 mm\^3 of gadolinium enhancement as determined by quantitative image analysis
|
|---|---|---|
|
Mean Standardized Change in Synovial Volume (SV) at 6 Weeks
|
-0.67 Standardized Units
Interval -0.8131 to -0.5296
|
-0.9 Standardized Units
Interval -1.0573 to -0.7341
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Participants with pre treatment synovial volume measurement as determined by quantitative image analysis, as well as a quality Week 6 MRI who received a single intra-articular (IA) injection of FX006 32 mg
Mean absolute change from baseline at 6 weeks in synovial volume (mm\^3) as measured by MRI and read by a central imaging vendor. The least squares mean changes are estimated using a mixed effects model for repeated measures with fixed effects for study time point, study site, baseline score and baseline femur bone volume (mm\^3) and a random effect for patient.
Outcome measures
| Measure |
Total Population
n=108 Participants
All patients who received a single intra-articular (IA) injection of FX006 32mg and had a pre-treatment synovial volume measurement
|
Patients With Baseline Synovitis
n=84 Participants
The subset of the Total Population who had a pre-treatment synovial volume measurement of greater than 3000 mm\^3 of gadolinium enhancement as determined by quantitative image analysis
|
|---|---|---|
|
Mean Absolute Change in Synovial Volume at 6 Weeks
|
-5469.68 mm^3
Standard Error 581.9123
|
-7549.55 mm^3
Standard Error 683.6488
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants with pre treatment synovial volume measurement as determined by quantitative image analysis, as well as a quality Week 24 MRI who received a single intra-articular (IA) injection of FX006 32 mg
Synovial volume (mm\^3) as measured by MRI and read by a central imaging vendor. Standardization was performed by dividing the model-derived least squares means and corresponding confidence intervals by the adjusted standard deviation (SD). Therefore, the mean standardized change represents the change in synovial volume expressed in standard deviation units.
Outcome measures
| Measure |
Total Population
n=88 Participants
All patients who received a single intra-articular (IA) injection of FX006 32mg and had a pre-treatment synovial volume measurement
|
Patients With Baseline Synovitis
n=68 Participants
The subset of the Total Population who had a pre-treatment synovial volume measurement of greater than 3000 mm\^3 of gadolinium enhancement as determined by quantitative image analysis
|
|---|---|---|
|
Mean Standardized Change in Synovial Volume (SV) at 24 Weeks
|
0.20 Standardized Units
Interval 0.0536 to 0.3371
|
0.20 Standardized Units
Interval 0.0385 to 0.3618
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants with pre-treatment synovial volume measurement as determined by quantitative image analysis, as well as a quality Week 24 MRI who received a single intra-articular (IA) injection of FX006 32 mg.
Mean absolute change (mm\^3) from baseline at 24 weeks in synovial volume (mm\^3) as measured by MRI and read by a central imaging vendor. The least squares mean changes are estimated using a mixed effects model for repeated measures with fixed effects for study time point, study site, baseline score and baseline femur bone volume (mm\^3) and a random effect for patient.
Outcome measures
| Measure |
Total Population
n=88 Participants
All patients who received a single intra-articular (IA) injection of FX006 32mg and had a pre-treatment synovial volume measurement
|
Patients With Baseline Synovitis
n=68 Participants
The subset of the Total Population who had a pre-treatment synovial volume measurement of greater than 3000 mm\^3 of gadolinium enhancement as determined by quantitative image analysis
|
|---|---|---|
|
Mean Absolute Change in Synovial Volume at 24 Weeks
|
3239.94 mm^3
Standard Error 1184.5800
|
3476.52 mm^3
Standard Error 1408.7997
|
Adverse Events
Total Population
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Patients With Baseline Synovitis
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total Population
n=129 participants at risk
All patients who received an attempted single intra-articular (IA) injection of FX006 32 mg
|
Patients With Baseline Synovitis
n=102 participants at risk
The subset of the Total Population who had a pre-treatment synovial volume measurement of greater than 3000 mm\^3 of gadolinium enhancement as determined by quantitative image analysis
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
Other adverse events
| Measure |
Total Population
n=129 participants at risk
All patients who received an attempted single intra-articular (IA) injection of FX006 32 mg
|
Patients With Baseline Synovitis
n=102 participants at risk
The subset of the Total Population who had a pre-treatment synovial volume measurement of greater than 3000 mm\^3 of gadolinium enhancement as determined by quantitative image analysis
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.00%
0/102 • Through study completion; up to 28 weeks
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.00%
0/102 • Through study completion; up to 28 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Endocrine disorders
Thyroid Cyst
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.00%
0/102 • Through study completion; up to 28 weeks
|
|
General disorders
Oedema Peripheral
|
1.6%
2/129 • Number of events 2 • Through study completion; up to 28 weeks
|
2.0%
2/102 • Number of events 2 • Through study completion; up to 28 weeks
|
|
General disorders
Pyrexia
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Infections and infestations
Acute Sinusitis
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Infections and infestations
Otitis Media
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.6%
2/129 • Number of events 2 • Through study completion; up to 28 weeks
|
2.0%
2/102 • Number of events 2 • Through study completion; up to 28 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Injury, poisoning and procedural complications
Procedural Anxiety
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Injury, poisoning and procedural complications
Synovial Rupture
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.00%
0/102 • Through study completion; up to 28 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.00%
0/102 • Through study completion; up to 28 weeks
|
|
Investigations
Cardiac Murmur
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.00%
0/102 • Through study completion; up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
7/129 • Number of events 8 • Through study completion; up to 28 weeks
|
6.9%
7/102 • Number of events 8 • Through study completion; up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.6%
2/129 • Number of events 2 • Through study completion; up to 28 weeks
|
2.0%
2/102 • Number of events 2 • Through study completion; up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Nervous system disorders
Dizziness
|
1.6%
2/129 • Number of events 2 • Through study completion; up to 28 weeks
|
2.0%
2/102 • Number of events 2 • Through study completion; up to 28 weeks
|
|
Nervous system disorders
Headache
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Nervous system disorders
Presyncope
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.78%
1/129 • Number of events 1 • Through study completion; up to 28 weeks
|
0.98%
1/102 • Number of events 1 • Through study completion; up to 28 weeks
|
Additional Information
David Golod, Vice President, Clinical Operations
Flexion Therapeutics, Inc.
Phone: (781) 305-7572
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place