Osteoarthritis of the ShoulderPhase 2NCT03382262

Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip

A Phase 2 study testing FX006 32 mg and TAcs 40 mg in people with Osteoarthritis of the Shoulder and Osteoarthritis of the Hip, run by Pacira Pharmaceuticals, Inc at 6 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 an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Osteoarthritis of the Shoulder, Osteoarthritis of the Hip
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: 55 participants
Where: 6 sitesUnited States
Study dates: 18 Dec 2017to 9 Oct 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
Body mass index (BMI) less than or equal to 40 kg/m2
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 treatments from Screening through End-of-Study visit

Show all 10Show fewer

Symptoms consistent with OA of the index joint for ≥ 6 months prior to Screening (patient reported is acceptable)
Pain in the index joint for greater than15 days over the last month (as reported by the patient)
For Shoulder OA patients: Radiologic findings of OA of the index shoulder meeting the Samilson-Prieto (S-P) Classification Grades 2 or 3
For Hip OA patients: ACR Criteria (clinical and radiological) for OA of the index hip

Who cannot join

Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in the index joint
Clinical findings consistent with active infection or crystal disease in the index joint within 1 month of Screening
History of fracture in the index limb within 12 months of Screening, or fracture with sequelae at any time
Planned or anticipated surgery of the index joint during the study period
Index joint instability or history of acute dislocation within 12 months of Screening

Show all 15Show fewer

If shoulder is the index joint, history of full or partial rotator cuff tear or significantly compromised rotator cuff function that, in the opinion for the Investigator, increases the difficulty or risk of IA injection
Presence of surgical hardware or other foreign body in the index joint
Surgery or arthroscopy of the index joint within 12 months of Screening
IA treatment of any joint with any of the following agents within 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 of the index joint 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

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
TriWest Research Associates, LLC
El Cajon, California, 92020
Biosolutions Clinical Research Center
La Mesa, California, 91942
Rochester Clinical Research
Rochester, New York, 14609
Artemis Institute for Clinical Research
San Diego, California, 92103
LA Biomed at Harbor-UCLA Medical Center
Torrance, California, 90509

Other trials in United States

About this study

Official title: A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of the Shoulder (Glenohumeral Joint) or Hip

Read the detailed description

This is a randomized, open-label, single dose study that will be conducted in male and female patients ≥40 years of age with OA of either the shoulder or the hip.

Approximately 24 patients with OA of the shoulder and approximately 24 patients with OA of the hip will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either:

32 mg FX006 (approximately 12 patients per joint) or
40 mg TAcs (approximately 12 patients per joint)

Each patient will be screened to confirm the diagnosis of OA of either the shoulder or hip and eligibility based on the other inclusion/exclusion requirements and will be randomized to treatment on Day 1. Each patient will be evaluated for a total of 12 weeks following the IA injection. Following screening, sampling for pharmacokinetics (PK) and safety will be completed at 10 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 3, 5, 8, 15, 22, 29, 57, and 85.

Conditions: Osteoarthritis of the Shoulder, Osteoarthritis of the Hip
Being tested: FX006 32 mg, TAcs 40 mg
Keywords: Osteoarthritis, Shoulder, Hip, Pain, Intra-articular, Injection, Corticosteroid
Medical subject headings: Osteoarthritis, Hip, 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
TAcs 40 mgDrug
Also called Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs), TCA-IR 40
Immediate-release 40mg TAcs IA injection

Study groups in NCT03382262
Study group	Role	What they receive
FX006 32 mg	Experimental	Single intra-articular (IA) injection of FX006 32 mg Receives: Drug: FX006 32 mg
TAcs 40 mg	Active comparator	Single intra-articular (IA) injection of TAcs 40 mg Receives: Drug: TAcs 40 mg

What is being measured

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

Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
Characterize the Pharmacokinetic Profile of FX006 and TCA IR [Time Frame: Day 1 (pre-treatment,1, 2, 3, 4, 5, 6, 8,10, and 12 hrs. post-dose) and Days 2, 3, 5, 8, 15, 22, 29, 57,and 85]
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: 12 Weeks
Total Number of Treatment Emergent Adverse Events
Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE). TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).
Measured: 12 Weeks

Timeline

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

18 Dec 20179 Oct 2018

First posted22 Dec 2017
Study start18 Dec 2017
Primary completion9 Oct 2018
Study completion9 Oct 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 (2)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis of the ShoulderStudies 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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03382262
Sponsor's protocol ID: FX006-2017-013
Status last verified: Jan 2024
First submitted: 6 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, Mehra P, Hanson P, Kwong L, Cinar A, Lufkin J, Kelley S. A Randomized, Open-Label, Single-Dose Study to Assess Safety and Systemic Exposure of Triamcinolone Acetonide Extended-Release in Patients With Hip Osteoarthritis. Rheumatol Ther. 2022 Apr;9(2):679-691. doi: 10.1007/s40744-022-00430-3. Epub 2022 Mar 8.
PubMed 35258839
Hanson P, Kivitz A, Mehra P, Kwong L, Cinar A, Lufkin J, Kelley SD. Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study. Drugs R D. 2021 Sep;21(3):285-293. doi: 10.1007/s40268-021-00348-1. Epub 2021 Aug 4.
PubMed 34350546

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 Shoulder 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 Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of the Shoulder (Glenohumeral Joint) or Hip
ClinicalTrials.gov ID: NCT03382262
Acronym / sponsor ID: FX006-2017-013
Conditions: Osteoarthritis of the Shoulder, Osteoarthritis of the Hip
Keywords: Osteoarthritis, Shoulder, Hip, Pain, Intra-articular, Injection, Corticosteroid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: 18 Dec 2017 (actual)
Primary completion: 9 Oct 2018 (actual)
Study completion: 9 Oct 2018 (actual)
First posted: 22 Dec 2017 (actual)
Results: Posted 9 Dec 2019

Clinical summary

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

Detailed description

This is a randomized, open-label, single dose study that will be conducted in male and female patients ≥40 years of age with OA of either the shoulder or the hip.

32 mg FX006 (approximately 12 patients per joint) or
40 mg TAcs (approximately 12 patients per joint)

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 mgSingle intra-articular (IA) injection of FX006 32 mg
TAcs 40 mg	Active comparator	Drug: TAcs 40 mgSingle intra-articular (IA) injection of TAcs 40 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
Body mass index (BMI) less than or equal to 40 kg/m2
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 (15 listed)

Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in the index joint
Clinical findings consistent with active infection or crystal disease in the index joint within 1 month of Screening
History of fracture in the index limb within 12 months of Screening, or fracture with sequelae at any time
Planned or anticipated surgery of the index joint during the study period

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
TAcs 40 mgAlso: Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs), TCA-IR 40Immediate-release 40mg TAcs IA injection	Drug	TAcs 40 mg

Primary outcome

Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
Time frame: 12 Weeks
Characterize the Pharmacokinetic Profile of FX006 and TCA IR [Time Frame: Day 1 (pre-treatment,1, 2, 3, 4, 5, 6, 8,10, and 12 hrs. post-dose) and Days 2, 3, 5, 8, 15, 22, 29, 57,and 85] 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
Total Number of Treatment Emergent Adverse Events
Time frame: 12 Weeks
Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE). TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).

Results and safety

Results posted to the registry on 9 Dec 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 Shoulder	12	12
TAcs 40 mg Shoulder	13	13
FX006 32 mg Hip	15	14
TAcs 40 mg Hip	15	14

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

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

Measure	FX006 32 mg Shoulder n = 12	TAcs 40 mg Shoulder n = 13	FX006 32 mg Hip n = 11	TAcs 40 mg Hip n = 14
Day 1 - Hour 1	1061.8 (819.95 to 1375.09)	1104.1 (578.17 to 2108.52)	681.8 (334.47 to 1389.69)	3862.3 (2024.11 to 7370.02)
Day 1 - Hour 2	1117.6 (838.98 to 1488.62)	1344.8 (682.40 to 2650.05)	752.2 (364.55 to 1551.90)	4052.4 (2134.61 to 7693.33)
Day 1 - Hour 3	1140.0 (849.77 to 1529.44)	1501.8 (774.05 to 2913.69)	748.0 (349.37 to 1601.44)	4519.3 (2286.88 to 8930.88)
Day 1 - Hour 4	1142.4 (822.55 to 1586.49)	1594.1 (856.43 to 2967.05)	776.1 (352.73 to 1707.82)	4557.8 (2362.49 to 8793.00)
Day 1 - Hour 5	1093.8 (759.94 to 1574.40)	1662.7 (861.73 to 3208.09)	792.9 (360.39 to 1744.51)	4672.6 (2429.24 to 8987.65)
Day 1 - Hour 6	1052.8 (729.94 to 1518.37)	1689.6 (893.53 to 3194.85)	743.5 (331.07 to 1669.73)	4469.8 (2393.87 to 8346.03)
Day 1 - Hour 8	1016.2 (702.66 to 1469.64)	1668.3 (887.88 to 3134.86)	705.0 (307.07 to 1618.77)	4102.3 (2232.93 to 7536.76)
Day 1 - Hour 10	951.4 (670.78 to 1349.34)	1506.3 (819.27 to 2769.61)	698.2 (307.74 to 1583.97)	3615.6 (2033.96 to 6427.30)

Population analysed: All patients in the Safety population who received study drug, completed scheduled sampling and had sufficient plasma concentration data. 50 of 55 patients were included. Four unique patients for whom hip was the index joint were excluded due to IP administration deviations. One of the four was also found to be enrolled at 2 separate study centers.

Primary outcome: Total Number of Treatment Emergent Adverse Events

Time frame: 12 Weeks. Number. Unit: Events

Measure	FX006 32 mg Shoulder n = 12	TAcs 40 mg Shoulder n = 13	FX006 32 mg Hip n = 15	TAcs 40 mg Hip n = 15
Value	10	7	8	17

Population analysed: All patients randomized to receive either FX006 or TAcs in the hip or shoulder.

Adverse events

Time frame: Adverse events were collected following IA administration through the final study visit at 12 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FX006 32 mg Shoulder	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
TAcs 40 mg Shoulder	0 of 13 (0%)	3 of 13 (23.1%)	0 of 13
FX006 32 mg Hip	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15
TAcs 40 mg Hip	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15

Limitations and caveats (from the sponsor): 4 patients with hip as index joint, were excluded from the PK population. 3 patients had incomplete FX006 administration. 1 patient enrolled at 2 different study centers; receiving TAcs and FX006 5 days apart in the same hip with no TEAEs reported.

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 35258839Kivitz A, Mehra P, Hanson P, Kwong L, Cinar A, Lufkin J, Kelley S. A Randomized, Open-Label, Single-Dose Study to Assess Safety and Systemic Exposure of Triamcinolone Acetonide Extended-Release in Patients With Hip Osteoarthritis. Rheumatol Ther. 2022 Apr;9(2):679-691. doi: 10.1007/s40744-022-00430-3. Epub 2022 Mar 8.
Derived from this study: PubMed 34350546Hanson P, Kivitz A, Mehra P, Kwong L, Cinar A, Lufkin J, Kelley SD. Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study. Drugs R D. 2021 Sep;21(3):285-293. doi: 10.1007/s40268-021-00348-1. Epub 2021 Aug 4.

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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

Pacira Pharmaceuticals, Inc

6 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 Osteoarthritis of the Shoulder and Osteoarthritis of the Hip, run by Pacira Pharmaceuticals, Inc at 6 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 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 6 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 9 Dec 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?

Concentration of Triamcinolone Acetonide (TA) in Blood Plasma (time frame: 12 Weeks). 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 NCT03382262, which also lists 2 linked publications.

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.