Osteoarthritis, KneePhase 3NCT03529942
Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee
A Phase 3 study testing FX006 32 mg in people with Osteoarthritis, Knee, run by Pacira Pharmaceuticals, Inc at 10 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- FX006 32 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 24 Apr 2018to 9 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Rush University Medical Center
Chicago, Illinois, 60612
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Duke University Medical Center
Durham, North Carolina, 27710
TriWest Research Associates, LLC
El Cajon, California, 92020
PMG Research, Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee, 37938
Biosolutions Research
La Mesa, California, 91942
Dream Team Clinical Research (formerly located in Anaheim)
Pomona, California, 91767
Dream Team Clinical Research
Pomona, California, 91767
About this study
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
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.
Read the detailed description
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. The study will be conducted in male and female patients who are ≥ 40 years of age.
Eligible patients who provide written consent and meet all entry criteria will undergo initial ultrasound examination and MRI with contrast of the index knee, and then receive a single IA injection of FX006 administered to the index knee at Baseline/Day 1. Patients will return to the clinic at Weeks 6 and 24 for an MRI with contrast of the index knee and other assessments. Patients must also have a blood sample drawn for Estimated Glomerular Filtration Rate (eGFR) testing within 30 days prior to the scheduled MRIs. In addition, a patient questionnaire will be administered and adverse events (AEs) and concomitant medication updates will be collected via telephone at Weeks 12 and 18.
- Conditions
- Osteoarthritis, Knee
- Being tested
- FX006 32 mg
- Keywords
- Osteoarthritis, Knee, Pain, Intra-articular, Injection, Corticosteroid
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX006 32 mgDrug
Also called Zilretta
Extended-release 32 mg FX006 IA injection
| Study group | Role | What they receive |
|---|---|---|
| FX006 32 mg | Experimental | Single intra-articular (IA) injection of FX006 32 mg Receives: Drug: FX006 32 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 6
Secondary outcomes (3)
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.
Measured: Baseline to Week 6
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.
Measured: Baseline to Week 24
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.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start24 Apr 2018
- Primary completion8 Nov 2019
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Kelley, MD, Study director, Flexion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529942
- Sponsor's protocol ID
- FX006-2017-014
- Status last verified
- Jan 2024
- First submitted
- 8 May 2018
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03529942
- Acronym / sponsor ID
- FX006-2017-014
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Pain, Intra-articular, Injection, Corticosteroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Posted 8 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The study will be conducted in male and female patients who are ≥ 40 years of age.
Eligible patients who provide written consent and meet all entry criteria will undergo initial ultrasound examination and MRI with contrast of the index knee, and then receive a single IA injection of FX006 administered to the index knee at Baseline/Day 1. Patients will return to the clinic at Weeks 6 and 24 for an MRI with contrast of the index knee and other assessments. Patients must also have a blood sample drawn for Estimated Glomerular Filtration Rate (eGFR) testing within 30 days prior to the scheduled MRIs. In addition, a patient questionnaire will be administered and adverse events (AEs) and concomitant medication updates will be collected via telephone at Weeks 12 and 18.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FX006 32 mg | Experimental | Drug: FX006 32 mgSingle intra-articular (IA) injection of FX006 32 mg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FX006 32 mgAlso: ZilrettaExtended-release 32 mg FX006 IA injection | Drug | FX006 32 mg |
Primary outcome
Mean Standardized Change in Synovial Volume (SV) at 6 Weeks
Time frame: Baseline to Week 6
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.
3 secondary outcomes
Mean Absolute Change in Synovial Volume at 6 Weeks
Time frame: Baseline to Week 6
Mean Standardized Change in Synovial Volume (SV) at 24 Weeks
Time frame: Baseline to Week 24
Mean Absolute Change in Synovial Volume at 24 Weeks
Time frame: Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Kelley, MD study director
Flexion Therapeutics
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FX006 32 mg in people with Osteoarthritis, Knee, run by Pacira Pharmaceuticals, Inc at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Standardized Change in Synovial Volume (SV) at 6 Weeks (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.