Osteoarthritis of the KneePhase 2NCT02003365

Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

A Phase 2 study testing FX006 10 mg, FX006 40 mg and TCA IR 40 mg in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee. 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 10 mg, FX006 40 mg and TCA IR 40 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesUnited States
Study dates: Nov 2013to Apr 2014
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
Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
Index knee pain for >15 days over the last month
Body mass index (BMI) ≤ 40 kg/m2
Ambulatory and in good general health

Who cannot join

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) within 12 months of Screening

Show all 15Show fewer

IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Dallas, Texas, 75231
Study site
Duncansville, Pennsylvania, 16635
Study site
Paducah, Kentucky, 42003

Other trials in United States

About this study

Official title: An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee

The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Read the detailed description

This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee.

Patients were enrolled sequentially with 8 patients per cohort, as follows:

Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12

Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.

Conditions: Osteoarthritis of the Knee
Being tested: FX006 10 mg, FX006 40 mg, TCA IR 40 mg
Keywords: osteoarthritis, knee, corticosteroids, triamcinolone acetonide, synovial fluid
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FX006 10 mgDrug
Extended-release formulation
FX006 40 mgDrug
Extended-release formulation
TCA IR 40 mgDrug
Also called Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Immediate-release formulation

Study groups in NCT02003365
Study group	Role	What they receive
FX006 10 mg	Experimental	Single 3 mL intra-articular (IA) injection Receives: Drug: FX006 10 mg
FX006 40 mg	Experimental	Single 3 mL intra-articular (IA) injection Receives: Drug: FX006 40 mg
TCA IR 40 mg	Active comparator	Single 1 mL intra-articular (IA) injection Receives: Drug: TCA IR 40 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of Triamcinolone Acetonide in Synovial Fluid
Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population.
Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).
Measured: 12 to 20 weeks

Secondary outcomes (1)

Plasma Drug Concentrations by Time
Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population.
Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ).
Measured: Weeks 6, 12, 16 and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Apr 2014

First posted6 Dec 2013 (estimated)
Study startNov 2013
Primary completionApr 2014
Study completionApr 2014

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: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02003365
Sponsor's protocol ID: FX006-2013-005
Status last verified: Jan 2024
First submitted: 18 Nov 2013
Last updated: 24 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis of the Knee trials

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 Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee
ClinicalTrials.gov ID: NCT02003365
Acronym / sponsor ID: FX006-2013-005
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis, knee, corticosteroids, triamcinolone acetonide, synovial fluid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 6 Dec 2013 (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 purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Detailed description

This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee.

Patients were enrolled sequentially with 8 patients per cohort, as follows:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
FX006 10 mg	Experimental	Drug: FX006 10 mgSingle 3 mL intra-articular (IA) injection
FX006 40 mg	Experimental	Drug: FX006 40 mgSingle 3 mL intra-articular (IA) injection
TCA IR 40 mg	Active comparator	Drug: TCA IR 40 mgSingle 1 mL intra-articular (IA) injection

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
Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
Index knee pain for >15 days over the last month

Key exclusion criteria (15 listed)

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

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 10 mgExtended-release formulation	Drug	FX006 10 mg
FX006 40 mgExtended-release formulation	Drug	FX006 40 mg
TCA IR 40 mgAlso: Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)Immediate-release formulation	Drug	TCA IR 40 mg

Primary outcome

Concentration of Triamcinolone Acetonide in Synovial Fluid
Time frame: 12 to 20 weeks
Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).

1 secondary outcome

Plasma Drug Concentrations by Time
Time frame: Weeks 6, 12, 16 and 20

Results and safety

Results posted to the registry on 12 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FX006 10 mg	10	10
FX006 40 mg	30	30
TCA IR 40 mg	10	9

Primary outcome: Concentration of Triamcinolone Acetonide in Synovial Fluid

Time frame: 12 to 20 weeks. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	FX006 10 mg n = 8	FX006 40 mg n = 15	TCA IR 40 mg n = 5
Week 12	477.5 (166.41 to 1369.91)	923.7 (74.24 to 11492.46)	250.1 (0.16 to 380930.9)
Week 16	NA (NA to NA)	224.3 (37.42 to 1344.70)	NA (NA to NA)
Week 20	NA (NA to NA)	33.3 (20.28 to 54.74)	NA (NA to NA)

Population analysed: All patients who received study drug and had synovial fluid obtained at the Final Visit were included in the Synovial Fluid Drug Concentration Population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FX006 10 mg	0 of 10 (0%)	5 of 10 (50%)	0 of 10
FX006 40 mg	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30
TCA IR	2 of 10 (20%)	4 of 10 (40%)	0 of 10

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.

Related trials for Osteoarthritis of the Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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

3 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 10 mg, FX006 40 mg and TCA IR 40 mg in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 3 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 15 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 3 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?

Concentration of Triamcinolone Acetonide in Synovial Fluid (time frame: 12 to 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02003365.

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.