Osteoarthritis of the KneePhase 3NCT02357459
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
A Phase 3 study testing FX006 and TCA IR 40 in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 38 sites in 8 countries.
Trial summary
The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis 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 and TCA IR 40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 38 sitesin 8 countries
- Study dates
- Jan 2015to Jan 2016
- 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
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Male or female >=40 years of age
- Has symptoms associated with OA of the index knee for at least 6 months prior to Screening
- 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 per Screening X-ray
- Index knee pain for > 15 days over the last month
Show all 9Show fewer
- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
- Body mass index (BMI) ≤ 40 kg/m2
- Willingness to abstain from use of restricted medications
Who cannot join
- Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain)
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
- History of infection in the index knee
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- Unstable joint within 12 months of screening
- IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
Show all 11Show fewer
- IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
- Any other IA investigational drug/biologic within 6 months of Screening
- Prior use of FX006
- Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Trial locations and contacts
38 sites in 8 countries.
38 sites in 8 countries
United States22 sites
Study site
Albuquerque, New Mexico, 87102
Study site
Anaheim, California, 92801
Study site
Atlantis, Florida, 33462
Study site
Canoga Park, California, 91303
Study site
Cary, North Carolina, 27518
PMG Research of Cary
Cary, North Carolina
Study site
Charlotte, North Carolina, 28209
Study site
Dallas, Texas, 75231
Study site
DeLand, Florida, 32720
Study site
Denver, Colorado, 80209
Study site
Duncansville, Pennsylvania, 16635
Study site
Hialeah, Florida, 33012
PMG Research of Knoxville
Knoxville, Tennessee, 37912
PMG Research of Knoxville
Knoxville, Tennessee, 37938
Study site
Newport News, Virginia, 23606
Study site
North Hollywood, California, 91606
Study site
Phoenix, Arizona, 85023
Study site
Prairie Village, Kansas, 66206
Study site
San Diego, California, 92103
Study site
Sarasota, Florida, 34232
Study site
Tucson, Arizona, 85712
Study site
West Palm Beach, Florida, 33409
Australia6 sites
Study site
Broadmeadow, New South Wales, 02292
Study site
Geelong, New South Wales, 03220
Study site
Malvern, Victoria, 03145
Study site
Merewether, New South Wales, 02291
Study site
Sherwood, Queensland, 04075
Study site
St Leonards, New South Wales, 02065
Canada3 sites
Study site
Quebec, Ontario, G1W4R4
Study site
Toronto, Ontario, M9V4B4
Study site
Windsor, Ontario, N8W1E6
Denmark3 sites
Study site
Aalborg
Study site
Ballerup Municipality
Study site
Vejle
About this study
Official title: A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.
Read the detailed description
This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
- 32 mg FX006,
- normal saline (placebo), or
- 40 mg TCA IR.
Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to <6, 6 to <7, and ≥7.
Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [baseline], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- FX006, Placebo, 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.
FX006Drug
Also called Zilretta
Single 5 mL IA injection
PlaceboDrug
Also called Normal Saline
Single 5 mL IA injection
TCA IR 40Drug
Also called Kenalog®-40 Injection, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Single 1 mL IA injection
| Study group | Role | What they receive |
|---|---|---|
| FX006 32mg | Experimental | Single 5 mL intra-articular (IA) injection Extended-release Formulation Receives: Drug: FX006 |
| Normal Saline | Placebo comparator | Single 5 mL intra-articular (IA) injection Receives: Drug: Placebo |
| TCA IR 40 mg | Active comparator | Single 1 mL intra-articular (IA) injection TCA IR 40 mg: 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.
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Measured: Baseline and 12 Weeks
Secondary outcomes (4)
Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Measured: Baseline to 12 Weeks
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Measured: Baseline to 12 Weeks
Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Measured: Baseline through 12 Weeks
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Measured: Baseline to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 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
- NCT02357459
- Sponsor's protocol ID
- FX006-2014-008
- Status last verified
- Jan 2024
- First submitted
- 3 Feb 2015
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ross E, Katz NP, Conaghan PG, Kivitz A, Turk DC, Spitzer AI, Jones DG, Lanier RK, Cinar A, Lufkin J, Kelley SD. Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. Pain Ther. 2022 Mar;11(1):289-302. doi: 10.1007/s40122-021-00335-z. Epub 2021 Nov 17.
PubMed 34791634Langworthy MJ, Conaghan PG, Ruane JJ, Kivitz AJ, Lufkin J, Cinar A, Kelley SD. Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. Adv Ther. 2019 Jun;36(6):1398-1411. doi: 10.1007/s12325-019-00944-3. Epub 2019 Apr 9.
PubMed 30968336
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 Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02357459
- Acronym / sponsor ID
- FX006-2014-008
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, knee, pain, corticosteroid, intra-articular, injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 1 Feb 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 assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.
Detailed description
This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
- 32 mg FX006,
- normal saline (placebo), or
- 40 mg TCA IR.
Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to <6, 6 to <7, and ≥7.
Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [baseline], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FX006 32mg | Experimental | Drug: FX006Single 5 mL intra-articular (IA) injection Extended-release Formulation |
| Normal Saline | Placebo comparator | Drug: PlaceboSingle 5 mL intra-articular (IA) injection |
| TCA IR 40 mg | Active comparator | Drug: TCA IR 40Single 1 mL intra-articular (IA) injection TCA IR 40 mg: 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 (9 listed)
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Male or female >=40 years of age
- Has symptoms associated with OA of the index knee for at least 6 months prior to Screening
- 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 per Screening X-ray
Key exclusion criteria (11 listed)
- Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain)
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
- History of infection in the index knee
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- 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 |
|---|---|---|
| FX006Also: ZilrettaSingle 5 mL IA injection | Drug | FX006 32mg |
| PlaceboAlso: Normal SalineSingle 5 mL IA injection | Drug | Normal Saline |
| TCA IR 40Also: Kenalog®-40 Injection, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)Single 1 mL IA injection | Drug | TCA IR 40 mg |
Primary outcome
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo
Time frame: Baseline and 12 Weeks
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
4 secondary outcomes
Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo
Time frame: Baseline to 12 Weeks
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
Time frame: Baseline to 12 Weeks
Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
Time frame: Baseline through 12 Weeks
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo
Time frame: Baseline to 24 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.
- Derived from this study: PubMed 34791634Ross E, Katz NP, Conaghan PG, Kivitz A, Turk DC, Spitzer AI, Jones DG, Lanier RK, Cinar A, Lufkin J, Kelley SD. Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. Pain Ther. 2022 Mar;11(1):289-302. doi: 10.1007/s40122-021-00335-z. Epub 2021 Nov 17.
- Derived from this study: PubMed 30968336Langworthy MJ, Conaghan PG, Ruane JJ, Kivitz AJ, Lufkin J, Cinar A, Kelley SD. Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. Adv Ther. 2019 Jun;36(6):1398-1411. doi: 10.1007/s12325-019-00944-3. Epub 2019 Apr 9.
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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
38 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FX006 and TCA IR 40 in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 38 sites in 8 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 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 38 sites in United States, Australia, Canada, Denmark, Estonia and 3 more countries. 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. Some participants in this study may receive a placebo. 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 1 Feb 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?
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo (time frame: Baseline and 12 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 NCT02357459, 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.