Post-traumatic Osteoarthritis of the KneePhase 2NCT02468583
Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
A Phase 2 study testing FX006 32 mg and TCA IR 40 mg in people with Post-traumatic Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Post-traumatic Osteoarthritis of the Knee
- What is being tested?
- FX006 32 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 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 20 to 50 years
- All sexes
- No healthy volunteers
- 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 ≥20 and ≤50 years of age
- Diagnosis of post-traumatic OA of the knee
- Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening
- 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 and therapies during the study
Who cannot join
- Prior osteotomy of the index knee
- Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to 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, or clinical signs and symptoms of active infection of the index knee
- Crystal disease of the index knee within one month of Screening
- Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or >2mm of articular incongruity after surgery
Show all 14Show fewer
- IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
- 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
- Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period
- Type 1 or Type 2 diabetes requiring insulin
- Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
San Antonio Military Medical Center
San Antonio, Texas, 78234
About this study
Official title: A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.
Read the detailed description
This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of:
- 32 mg of FX006
- 40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP)
Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.
- Being tested
- FX006 32 mg, TCA IR 40 mg
- Keywords
- Osteoarthritis, Post-traumatic, Knee, Pain, Corticosteroid, 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
Experimental
TCA IR 40 mgDrug
Also called Kenalog®-40, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Comparator
| Study group | Role | What they receive |
|---|---|---|
| FX006 32mg | Experimental | Single 5 mL intra-articular (IA) injection Extended-release formulation Receives: Drug: FX006 32 mg |
| TCA IR 40 mg | Active comparator | Single 1 mL intra-articular (IA) injection Immediate-release formulation Receives: Drug: TCA IR 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Measured: 5-10 Weeks
Secondary outcomes (15)
Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Measured: 12 Weeks
Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Measured: 12 Weeks
Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week
Measured: 12 Weeks
Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Measured: 12 Weeks
WOMAC A (Pain Subscale)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Measured: 12 weeks
WOMAC A1 (Pain on Walking Question)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Measured: 12 weeks
WOMAC B (Stiffness)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Measured: 12 weeks
WOMAC C (Function)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Measured: 12 weeks
WOMAC (Total):
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Measured: 12 weeks
Knee Injury and Osteoarthritis Score (KOOS)
change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Measured: 12 weeks
Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12
Measured: 12 weeks
Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12
Measured: 12 weeks
Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12
Measured: 12 weeks
Time to Onset of Pain Relief
Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing >30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline
Measured: Baseline to >30% improvement
Average Weekly and Total Consumption of Rescue Medication
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionJul 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 Post-traumatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 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
- NCT02468583
- Sponsor's protocol ID
- FX006-2014-007
- Status last verified
- Jan 2024
- First submitted
- 27 May 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
- A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02468583
- Acronym / sponsor ID
- FX006-2014-007
- Keywords
- Osteoarthritis, Post-traumatic, Knee, Pain, Corticosteroid, Intra-articular, Injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Posted 21 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.
Detailed description
This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of:
- 32 mg of FX006
- 40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP)
Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FX006 32mg | Experimental | Drug: FX006 32 mgSingle 5 mL intra-articular (IA) injection Extended-release formulation |
| TCA IR 40 mg | Active comparator | Drug: TCA IR 40 mgSingle 1 mL intra-articular (IA) injection Immediate-release formulation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Male or female ≥20 and ≤50 years of age
- Diagnosis of post-traumatic OA of the knee
- Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening
- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Key exclusion criteria (14 listed)
- Prior osteotomy of the index knee
- Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to 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, or clinical signs and symptoms of active infection of the index knee
- Crystal disease of the index knee within one month 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: ZilrettaExperimental | Drug | FX006 32mg |
| TCA IR 40 mgAlso: Kenalog®-40, Triamcinolone Acetonide Crystalline Suspension (TAcs)Comparator | Drug | TCA IR 40 mg |
Primary outcome
Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10
Time frame: 5-10 Weeks
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
15 secondary outcomes
Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12
Time frame: 12 Weeks
Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Time frame: 12 Weeks
Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week
Time frame: 12 Weeks
Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
Time frame: 12 Weeks
WOMAC A (Pain Subscale)
Time frame: 12 weeks
WOMAC A1 (Pain on Walking Question)
Time frame: 12 weeks
WOMAC B (Stiffness)
Time frame: 12 weeks
WOMAC C (Function)
Time frame: 12 weeks
WOMAC (Total):
Time frame: 12 weeks
Knee Injury and Osteoarthritis Score (KOOS)
Time frame: 12 weeks
Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12
Time frame: 12 weeks
Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12
Time frame: 12 weeks
Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12
Time frame: 12 weeks
Time to Onset of Pain Relief
Time frame: Baseline to >30% improvement
Average Weekly and Total Consumption of Rescue Medication
Time frame: 12 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
1 site 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 mg in people with Post-traumatic Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 1 site 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 14 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: stopped early, 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 1 site 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 21 Dec 2017). 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?
Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10 (time frame: 5-10 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.