Osteoarthritis, Knee Clinical Trial
Official title:
An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Verified date | January 2024 |
Source | Pacira Pharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label study assessing the effect of the administration of a single intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with osteoarthritis (OA) of the knee.
Status | Completed |
Enrollment | 129 |
Est. completion date | March 9, 2020 |
Est. primary completion date | November 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Written consent to participate in the study - Male or female = 40 years of age - Body mass index (BMI) = 40 kg/m^2 - Ambulatory and in good general health - Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions - Willing to abstain from use of protocol-restricted medications during the study - Symptoms associated with OA of the index knee for = 6 months prior to Screening (patient self-report is acceptable) - Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA - Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee based on X-ray performed during Screening (centrally read) Exclusion Criteria: - Any inflammatory arthritis including reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, gout or secondary OA from gout - History of infection or crystal disease in the index knee joint - Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening - Surgery or arthroscopy of the index knee within 12 months of Screening - IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening - IA treatment of the index knee with hyaluronic acid (investigational or marketed) within 6 months of Screening - IV or IM corticosteroids (investigational or marketed) within 3 months of Screening - Oral corticosteroids (investigational or marketed) within 1 month of Screening - Any other IA drug/biologic in the index knee within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy and amniotic fluid injection) - Prior administration of FX006 - eGFR results <40 mL/minute - Any contraindication to MRI Scanning (e.g., presence of certain ferromagnetic foreign bodies or electronic devices including most cardiac pacemakers, claustrophobia) - Known hypersensitivity to any form of radiographic contrast - Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Leeds | Leeds | |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Tampa Bay Medical Research, Inc. | Clearwater | Florida |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | Duke University Medical Center | Durham | North Carolina |
United States | TriWest Research Associates, LLC | El Cajon | California |
United States | PMG Research, Inc. d/b/a PMG Research of Knoxville | Knoxville | Tennessee |
United States | Biosolutions Research | La Mesa | California |
United States | Dream Team Clinical Research | Pomona | California |
United States | Dream Team Clinical Research (formerly located in Anaheim) | Pomona | California |
Lead Sponsor | Collaborator |
---|---|
Pacira Pharmaceuticals, Inc |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Standardized Change in Synovial Volume (SV) at 6 Weeks | 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. | Baseline to Week 6 | |
Secondary | Mean Absolute Change in Synovial Volume at 6 Weeks | 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. | Baseline to Week 6 | |
Secondary | Mean Standardized Change in Synovial Volume (SV) at 24 Weeks | 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. | Baseline to Week 24 | |
Secondary | Mean Absolute Change in Synovial Volume at 24 Weeks | 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. | Baseline to Week 24 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03895489 -
Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses
|
N/A | |
Completed |
NCT03660943 -
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
|
Phase 3 | |
Completed |
NCT04531969 -
Comparison of Outpatient and Inpatient Spa Therapy
|
N/A | |
Completed |
NCT02848027 -
Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
|
Phase 3 | |
Completed |
NCT05160246 -
The Instant Effect of Kinesiology Taping in Patients With Knee OA
|
N/A | |
Recruiting |
NCT06080763 -
Biomechanics and Clinical Outcomes in Responders and Non-Responders
|
||
Completed |
NCT03643588 -
The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
|
N/A | |
Active, not recruiting |
NCT05100225 -
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
|
Phase 2 | |
Active, not recruiting |
NCT04061733 -
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
|
N/A | |
Completed |
NCT04051489 -
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
|
||
Recruiting |
NCT05546541 -
Epidemiology and Nutrition
|
||
Recruiting |
NCT05447767 -
Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg
|
Phase 2 | |
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Not yet recruiting |
NCT03225911 -
Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis
|
N/A | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Completed |
NCT05703087 -
Positive Cueing in Knee Arthroplasty.
|
N/A | |
Not yet recruiting |
NCT06042426 -
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
|
Phase 4 | |
Completed |
NCT02901964 -
Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial
|
N/A | |
Not yet recruiting |
NCT02826850 -
Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial
|
Phase 3 | |
Completed |
NCT02905747 -
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
|
N/A |