Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA
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| ClinicalTrials.gov Identifier: NCT03378076 |
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Recruitment Status :
Completed
First Posted : December 19, 2017
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bilateral Knee Osteoarthritis | Drug: FX006 32 mg Drug: TAcs 40 mg | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | December 6, 2017 |
| Actual Primary Completion Date : | March 14, 2018 |
| Actual Study Completion Date : | March 14, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: FX006 32 mg
Two intra-articular (IA) injections of FX006 32 mg (total dose of 64 mg)
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Drug: FX006 32 mg
Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)
Other Name: Zilretta |
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Active Comparator: TAcs 40 mg
Two intra-articular (IA) injections of TAcs 40 mg (total dose of 80 mg)
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Drug: TAcs 40 mg
Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)
Other Names:
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- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378076
| United States, California | |
| LA Biomed at Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90509 | |
| United States, New York | |
| Rochester Clinical Research | |
| Rochester, New York, United States, 14609 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Study Director: | Scott Kelley, MD | Flexion Therapeutics, Inc. |
Documents provided by Flexion Therapeutics, Inc.:
| Responsible Party: | Flexion Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03378076 History of Changes |
| Other Study ID Numbers: |
FX006-2017-012 |
| First Posted: | December 19, 2017 Key Record Dates |
| Results First Posted: | May 1, 2019 |
| Last Update Posted: | May 1, 2019 |
| Last Verified: | April 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Osteoarthritis Knee Corticosteroid Bilateral |
Pain Intra-articular Injection |
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Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Triamcinolone diacetate |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |