Phase 2
Completed N=24
Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT01487200 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Change From Baseline in 24-hour Weighted Mean Serum Cortisol — -7.7; -42.7; -62.2; -59.0 weighted mean serum cortisol (nmol/L)
Summary
The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 24-hour Weighted Mean Serum Cortisol |
-7.7; -42.7; -62.2; -59.0; -11.1; -33.4 | — |
| PRIMARY Characterize the Pharmacokinetic Profile of FX006 and TCA IR |
140.941; 638.447; 862.574; 12268.835; 226.058; 779.819 | — |
| SECONDARY Change From Baseline in 24-hour Urinary Free Cortisol Excretion |
47.9; -43.8; -50.1; -58.5; 13.0; -42.4 | — |
| SECONDARY Total 24-hour Urinary Free Cortisol Excretion |
75.66; 29.94; 29.36; 18.77; 57.14; 30.91 | — |
| SECONDARY Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol |
-30.2; -42.3; -78.2; -85.4; -24.9; -40.8 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Male or female >=35 years of age
- Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
- Body mass index (BMI) ≤ 40 kg/m2
- Willingness to abstain from use of the protocol-specified restricted medications
Main Exclusion Criteria:
- History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
- History of arthritides due to crystals (e.g., gout, pseudogout)
- History of infection in the index joint
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee
- Presence of surgical hardware or other foreign body in the index knee
- Unstable joint (such as a torn anterior cruciate ligament)
- 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
- Oral, inhaled or intranasal corticosteroids (investigational or marketed) within 1 month of Screening
- Prior arthroscopic or open surgery of the index knee within 12 months of Screening
- Planned/anticipated surgery of the index knee during the study period
- History of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years
- Insulin-dependent diabetes
- History of or active Cushing's syndrome
- Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
- Skin breakdown at the knee where the injection would take place
- Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT01487200). 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.