Bilateral Knee OsteoarthritisPhase 2NCT03378076

Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

A Phase 2 study testing FX006 32 mg and TAcs 40 mg in people with Bilateral Knee Osteoarthritis, 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

This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Bilateral Knee Osteoarthritis
What is being tested?: FX006 32 mg and TAcs 40 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 3 sitesUnited States
Study dates: 6 Dec 2017to 14 Mar 2018
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
Male or female greater than or equal to 40 years of age
Symptoms consistent with OA in both knees for greater than or equal to 6 months prior to Screening (patient reported is acceptable)
Currently meets ACR Criteria (clinical and radiological) for OA in both knees
Knee pain in both knees for greater than 15 days over the last month (as reported by the patient)
Body mass index (BMI) less than or equal to 40 kg/m2

Show all 10Show fewer

Morning serum cortisol result within normal range at Screening (5-23 mcg/dL or 138-635 nmol/dL)
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

Who cannot join

Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in either knee joint
Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12 months of Screening
Presence of surgical hardware or other foreign body in either knee
Surgery or arthroscopy of either knee within 12 months of Screening

Show all 11Show fewer

IA treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).
IA treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
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

3 sites in 1 country.

United States3 sites

Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Rochester Clinical Research
Rochester, New York, 14609
LA Biomed at Harbor-UCLA Medical Center
Torrance, California, 90509

Other trials in United States

About this study

Official title: A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)

This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Read the detailed description

This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA.

Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with IA injections to both knees of either:

extended-release FX006 64 mg total dose (approximately 12 patients) or
immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on Day 1. Following screening, pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 8, 15, 29, and 43.

Conditions: Bilateral Knee Osteoarthritis
Being tested: FX006 32 mg, TAcs 40 mg
Keywords: Osteoarthritis, Knee, Corticosteroid, Bilateral, Pain, Intra-articular, Injection
Medical subject headings: 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
Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)
TAcs 40 mgDrug
Also called Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs), TCA-IR 40
Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)

Study groups in NCT03378076
Study group	Role	What they receive
FX006 32 mg	Experimental	Two intra-articular (IA) injections of FX006 32 mg (total dose of 64 mg) Receives: Drug: FX006 32 mg
TAcs 40 mg	Active comparator	Two intra-articular (IA) injections of TAcs 40 mg (total dose of 80 mg) Receives: Drug: TAcs 40 mg

What is being measured

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

Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma.
For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations
Measured: 43 days
Incidence of Treatment Emergent Adverse Events
Safety analyses were conducted using the safety population.
Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE).
Measured: 43 days

Timeline

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

6 Dec 201714 Mar 2018

First posted19 Dec 2017
Study start6 Dec 2017
Primary completion14 Mar 2018
Study completion14 Mar 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bilateral Knee OsteoarthritisStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03378076
Sponsor's protocol ID: FX006-2017-012
Status last verified: Jan 2024
First submitted: 8 Dec 2017
Last updated: 24 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Kivitz A, Kwong L, Shlotzhauer T, Lufkin J, Cinar A, Kelley S. A randomized, phase IIa study to assess the systemic exposure of triamcinolone acetonide following injection of extended-release triamcinolone acetonide or traditional triamcinolone acetonide into both knees of patients with bilateral knee osteoarthritis. Ther Adv Musculoskelet Dis. 2019 Oct 16;11:1759720X19881309. doi: 10.1177/1759720X19881309. eCollection 2019.
PubMed 31662801

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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Whole-body Vibration Training on the Elderly With Combined Bilateral Knee Osteoarthritis
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COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty
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Effect of Tergase Injection on Reducing Edema After Bilateral Total Knee Arthroplasty
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All Bilateral Knee Osteoarthritis 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: A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)
ClinicalTrials.gov ID: NCT03378076
Acronym / sponsor ID: FX006-2017-012
Conditions: Bilateral Knee Osteoarthritis
Keywords: Osteoarthritis, Knee, Corticosteroid, Bilateral, Pain, Intra-articular, Injection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: 6 Dec 2017 (actual)
Primary completion: 14 Mar 2018 (actual)
Study completion: 14 Mar 2018 (actual)
First posted: 19 Dec 2017 (actual)
Results: Posted 1 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Detailed description

This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA.

Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with IA injections to both knees of either:

extended-release FX006 64 mg total dose (approximately 12 patients) or
immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on Day 1. Following screening, pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 8, 15, 29, and 43.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FX006 32 mg	Experimental	Drug: FX006 32 mgTwo intra-articular (IA) injections of FX006 32 mg (total dose of 64 mg)
TAcs 40 mg	Active comparator	Drug: TAcs 40 mgTwo intra-articular (IA) injections of TAcs 40 mg (total dose of 80 mg)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Written consent to participate in the study
Male or female greater than or equal to 40 years of age
Symptoms consistent with OA in both knees for greater than or equal to 6 months prior to Screening (patient reported is acceptable)
Currently meets ACR Criteria (clinical and radiological) for OA in both knees
Knee pain in both knees for greater than 15 days over the last month (as reported by the patient)

Key exclusion criteria (11 listed)

Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in either knee joint
Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12 months of Screening
Presence of surgical hardware or other foreign body in either 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 32 mgAlso: ZilrettaDrug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)	Drug	FX006 32 mg
TAcs 40 mgAlso: Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs), TCA-IR 40Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)	Drug	TAcs 40 mg

Primary outcome

Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
Time frame: 43 days
Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma. For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations
Incidence of Treatment Emergent Adverse Events
Time frame: 43 days
Safety analyses were conducted using the safety population. Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE).

Results and safety

Results posted to the registry on 1 May 2019, 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 32 mg	12	12
TAcs IR 40 mg	12	12

Primary outcome: Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

Time frame: 43 days. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	FX006 32 mg n = 12	TAcs 40 mg n = 12
Day 1- Hour 1	1801.5 (1261.50 to 2572.77)	4507.9 (1205.43 to 16857.74)
Day 1 - Hour 2	1893.6 (1328.58 to 2698.84)	5140.1 (1327.67 to 19899.79)
Day 1 - Hour 3	1958.1 (1336.54 to 2868.86)	5443.8 (1357.81 to 21825.90)
Day 1 - Hour 4	2013.8 (1381.39 to 2935.59)	5454.2 (1409.98 to 21098.36)
Day 1 - Hour 5	1914.4 (1291.93 to 2836.82)	5338.9 (1366.93 to 20852.59)
Day 1 - Hour 6	1900.2 (1293.77 to 2790.96)	5430.6 (1442.24 to 20448.57)
Day 1 - Hour 8	1928.1 (1288.45 to 2885.17)	5199.0 (1418.52 to 19054.80)
Day 1 - Hour 10	1839.8 (1241.72 to 2725.96)	4948.8 (1392.07 to 17593.31)

Population analysed: All patients who received 2 IA injections (one in each knee) of study drug, completed scheduled sampling, and had sufficient plasma concentration data

Primary outcome: Incidence of Treatment Emergent Adverse Events

Time frame: 43 days. Number. Unit: participants

Measure	FX006 32 mg n = 12	TAcs 40 mg n = 12
Patients with TEAE Grade 1	6	3
Patients with TEAE Grade 2	1	2
Patients with TEAE Grade 3	1	0
Patients with TEAE Grade 4	0	0
Patients with TEAE Grade 5	0	0

Population analysed: All patients who received study drug (injection in at least one knee).

Adverse events

Time frame: Adverse Events were collected following IA administration through the final study visit at 43 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FX006 32 mg	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12
TAcs 40 mg	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12

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.
Derived from this study: PubMed 31662801Kivitz A, Kwong L, Shlotzhauer T, Lufkin J, Cinar A, Kelley S. A randomized, phase IIa study to assess the systemic exposure of triamcinolone acetonide following injection of extended-release triamcinolone acetonide or traditional triamcinolone acetonide into both knees of patients with bilateral knee osteoarthritis. Ther Adv Musculoskelet Dis. 2019 Oct 16;11:1759720X19881309. doi: 10.1177/1759720X19881309. eCollection 2019.

Related trials for Bilateral Knee Osteoarthritis

Enrolling by invitation
Whole-body Vibration Training on the Elderly With Combined Bilateral Knee Osteoarthritis
Knee OA, Sarcopenic Obesity
RecruitingPhase 1/2
COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty
Total Knee Anthroplasty, Osteoarthritis(Primary)
Not yet recruiting
Effect of Tergase Injection on Reducing Edema After Bilateral Total Knee Arthroplasty
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Not yet recruiting
Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty
Knee Osteoarthritis, Total Knee Arthroplasty
Not yet recruiting
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Knee Osteoarthritis (OA)

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

Pacira Pharmaceuticals, Inc

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 32 mg and TAcs 40 mg in people with Bilateral Knee Osteoarthritis, 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 10 inclusion and 11 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 1 May 2019). 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?

Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma (time frame: 43 days). The study lists 2 primary outcomes in all. 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 NCT03378076, which also lists 1 linked publication.

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.