Phase 3
Completed N=208
Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT03046446 ↗Enrolled (actual)
208
Serious AEs
1.9%
Results posted
Oct 2019
Primary outcomePrimary: Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006 — 336 TEAEs
◆ Published Evidence
Established
38citations · ~5 / year
Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study.
Summary
This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee
Linked Publications
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Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006 |
336 | — |
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
- Male or female ≥ 40 years of age
- Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening
- Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
- Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the index knee based on X-ray performed during Screening
- Qualifying score for WOMAC A at Screening and Day 1/Baseline
- 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
- Willingness 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 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 index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening
- IA corticosteroid (investigational or marketed) in index knee within 3 months of Screening
- IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
- Oral corticosteroids (investigational or marketed) within 1 month of Screening
- Any other IA drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy and amniotic fluid injection)
- Prior administration of FX006
- Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT03046446) and the linked publication. 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.