Osteoarthritis of the KneePhase 2NCT02637323
Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee
A Phase 2 study testing FX006 32 mg and TCA IR 40 in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 4 sites in United States.
Trial summary
The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- FX006 32 mg and TCA IR 40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2015to Sep 2016
- Phase
- Phase 2
- 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
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable)
- Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
- Index knee pain for >15 days over the last month (as reported by the patient)
- Body mass index (BMI) ≤ 40 kg/m2
- Ambulatory and in good general health
Who cannot join
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- History of infection in the index knee joint
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- Presence of surgical hardware or other foreign body in the index knee
- Unstable joint within 12 months of Screening
- IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
Show all 13Show fewer
- IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening
- Oral corticosteroids (investigational or marketed) within 1 month of Screening
- Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
- Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer)
- Prior use of FX006
- Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Canoga Park, California, 91303
Study site
Duncansville, Pennsylvania, 16635
Study site
Hialeah, Florida, 33012
Study site
San Diego, California, 92103
About this study
Official title: An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee
The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
Read the detailed description
This study employed an open-label, single administration design and was conducted in male and female patients ≥40 years of age with OA of the knee.
Patients were enrolled sequentially with at least 10 patients per cohort as follows:
Cohort A: FX006 32 mg, Final Visit at Week 20 Cohort B: FX006 32 mg, Final Visit at Week 16 Cohort C: FX006 32 mg, Final Visit at Week 12 Cohort D: FX006 32 mg, Final Visit at Week 6 Cohort E: FX006 32 mg, Final Visit at Week 1 Cohort F: TCA IR 40 mg, Final Visit Week 6
Each patient was screened to confirm eligibility and assigned to a cohort on Day 1/baseline. Each patient was evaluated for safety during his/her participation in the study at 6, 12, 16, or 20 weeks following a single IA injection depending on the assigned Cohort, and plasma and synovial fluid was collected for drug concentration measurements.
Safety and tolerability was assessed by physical examinations, index knee examinations, vital signs, clinical laboratory evaluations, and adverse events (AEs).
No efficacy assessments were employed in this study.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- FX006 32 mg, TCA IR 40
- Keywords
- osteoarthritis, knee, pain, corticosteroid, intra-articular, injection
- 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
Single 5 mL IA injection
TCA IR 40Drug
Also called Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Single 1 mL IA injection
| Study group | Role | What they receive |
|---|---|---|
| FX006 32 mg | Experimental | Single 5 mL intra-articular (IA) injection Extended-release formulation Receives: Drug: FX006 32 mg |
| TCA IR 40 mg | Active comparator | Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation Receives: Drug: TCA IR 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).
Measured: Up to 20 Weeks
Secondary outcomes (1)
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations.
Measured: Up to 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2016
- Study completionSep 2016
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 of the 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Bodick, MD, Study director, Flexion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637323
- Sponsor's protocol ID
- FX006-2015-009
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2015
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02637323
- Acronym / sponsor ID
- FX006-2015-009
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, knee, pain, corticosteroid, intra-articular, injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 12 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
Detailed description
This study employed an open-label, single administration design and was conducted in male and female patients ≥40 years of age with OA of the knee.
Patients were enrolled sequentially with at least 10 patients per cohort as follows:
Cohort A: FX006 32 mg, Final Visit at Week 20 Cohort B: FX006 32 mg, Final Visit at Week 16 Cohort C: FX006 32 mg, Final Visit at Week 12 Cohort D: FX006 32 mg, Final Visit at Week 6 Cohort E: FX006 32 mg, Final Visit at Week 1 Cohort F: TCA IR 40 mg, Final Visit Week 6
Each patient was screened to confirm eligibility and assigned to a cohort on Day 1/baseline. Each patient was evaluated for safety during his/her participation in the study at 6, 12, 16, or 20 weeks following a single IA injection depending on the assigned Cohort, and plasma and synovial fluid was collected for drug concentration measurements.
Safety and tolerability was assessed by physical examinations, index knee examinations, vital signs, clinical laboratory evaluations, and adverse events (AEs).
No efficacy assessments were employed in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FX006 32 mg | Experimental | Drug: FX006 32 mgSingle 5 mL intra-articular (IA) injection Extended-release formulation |
| TCA IR 40 mg | Active comparator | Drug: TCA IR 40Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written consent to participate in the study
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable)
- Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
- Index knee pain for >15 days over the last month (as reported by the patient)
Key exclusion criteria (13 listed)
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- History of infection in the index knee joint
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- Presence of surgical hardware or other foreign body in the index knee
- Unstable joint within 12 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: ZilrettaSingle 5 mL IA injection | Drug | FX006 32 mg |
| TCA IR 40Also: Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)Single 1 mL IA injection | Drug | TCA IR 40 mg |
Primary outcome
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Time frame: Up to 20 Weeks
All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).
1 secondary outcome
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Time frame: Up to 20 Weeks
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.
Neil Bodick, MD study director
Flexion Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FX006 32 mg and TCA IR 40 in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 4 sites in United States.
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 7 inclusion and 13 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 4 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Jan 2018). 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?
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid (time frame: Up to 20 Weeks). 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.