Phase 2
Completed N=81
Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee
Source: ClinicalTrials.gov NCT02637323 ↗Enrolled (actual)
81
Serious AEs
1.2%
Results posted
Jan 2018
Primary outcomePrimary: Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid — 1.0; 1.0; 231328.9; 3590.0 pg/mL
Summary
The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid |
1.0; 1.0; 231328.9; 3590.0; 7.7; 290.6 | — |
| SECONDARY Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort |
670.0; 6968.8; 736.5; 8494.7; 759.5; 9628.8 | — |
Eligibility Criteria
Inclusion Criteria
- Written consent to participate in the study
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable)
- Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
- Index knee pain for >15 days over the last month (as reported by the patient)
- Body mass index (BMI) ≤ 40 kg/m2
- Ambulatory and in good general health
Exclusion Criteria
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- History of infection in the index knee joint
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- Presence of surgical hardware or other foreign body in the index knee
- Unstable joint within 12 months of Screening
- IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
- IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening
- Oral corticosteroids (investigational or marketed) within 1 month of Screening
- Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
- Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer)
- Prior use of FX006
- Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02637323). 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.