Phase 2
Completed N=229
Study of FX006 in Patients With Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT01487161 ↗Enrolled (actual)
229
Serious AEs
1.3%
Results posted
Jan 2018
Primary outcomePrimary: Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg — -3.9; -3.4 units on a scale — p=0.1249
Summary
The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg |
-3.9; -3.4 | 0.1249 |
| PRIMARY Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg |
-3.6; -3.3 | 0.2002 |
| PRIMARY Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg |
-3.2; -3.3 | 0.5541 |
| SECONDARY Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg |
-3.9; -4.3; -3.4; -3.8; -4.1; -3.3 | — |
| SECONDARY Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score. |
-2.7; -3.0; -3.0; -3.1; -3.6; -3.9 | — |
| SECONDARY WOMAC A (Pain Subscale) Change From Baseline at Week 8 |
-1.23; -1.33; -1.16; -0.96 | — |
| SECONDARY WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8 |
-1.2; -1.2; -1.1; -0.8 | — |
| SECONDARY WOMAC B (Stiffness Subscale) Change From Baseline at Week 8 |
-1.37; -1.49; -1.24; -0.99 | — |
| SECONDARY WOMAC C (Function Subscale) Change From Baseline at Week 8 |
-1.22; -1.31; -1.13; -0.94 | — |
| SECONDARY Percent of Responders According to OMERACT-OARSI Criteria at Week 8 |
52; 53; 47; 32 | — |
| SECONDARY Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 |
35; 40; 34; 23 | — |
| SECONDARY Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 |
42; 47; 45; 27 | — |
| SECONDARY Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 |
47; 49; 48; 30 | — |
| SECONDARY Patient Global Impression of Change Scores at Week 8 |
1.9; 1.8; 2.4; 2.5 | — |
| SECONDARY Clinical Global Impression of Change Scores at Week 8 |
1.9; 1.8; 2.5; 2.6 | — |
| SECONDARY Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks. |
1.0; 1.0; 1.1; 1.2 | — |
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 >=40 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
- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
- Body mass index (BMI) ≤ 40 kg/m2
- Willingness to abstain from use of restricted medications
Main Exclusion Criteria
- Ipsilateral hip OA
- Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
- 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 and 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
- Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
- Insulin-dependent diabetes
- Active psychiatric disorder including psychosis and major depressive disorder
- 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 (NCT01487161). 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.