Phase 2
Completed N=24
Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA
Bilateral Knee Osteoarthritis
Source: ClinicalTrials.gov NCT03378076 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma — 1801.5; 4507.9; 1893.6; 5140.1 pg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma |
1801.5; 4507.9; 1893.6; 5140.1; 1958.1; 5443.8 | — |
| PRIMARY Incidence of Treatment Emergent Adverse Events |
6; 3; 1; 2; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03378076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.