Clinical trial NCT02468583: Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
Official title: A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post-traumatic Osteoarthritis of the Knee
Keywords: Osteoarthritis
Post-traumatic
Knee
Pain
Corticosteroid
Intra-articular
Injection
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2015-06-11
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.

Detailed description: This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of:

* 32 mg of FX006
* 40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP)

Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.

Eligibility criteria: 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 ≥20 and ≤50 years of age
* Diagnosis of post-traumatic OA of the knee
* Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening
* 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 and therapies during the study

Exclusion Criteria:

* Prior osteotomy of the index knee
* Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to or greater than the index knee pain)
* Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
* History of, or clinical signs and symptoms of active infection of the index knee
* Crystal disease of the index knee within one month of Screening
* Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or \>2mm of articular incongruity after surgery
* 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
* Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
* Any other IA investigational drug/biologic within 6 months of Screening
* Prior use of FX006
* Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period
* Type 1 or Type 2 diabetes requiring insulin
* Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Primary outcomes:
measure: Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10
timeFrame: 5-10 Weeks
Secondary outcomes:
measure: Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12
timeFrame: 12 Weeks
measure: Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
timeFrame: 12 Weeks
measure: Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week
timeFrame: 12 Weeks
measure: Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week
timeFrame: 12 Weeks
measure: WOMAC A (Pain Subscale)
timeFrame: 12 weeks
measure: WOMAC A1 (Pain on Walking Question)
timeFrame: 12 weeks
measure: WOMAC B (Stiffness)
timeFrame: 12 weeks
measure: WOMAC C (Function)
timeFrame: 12 weeks
measure: WOMAC (Total):
timeFrame: 12 weeks
measure: Knee Injury and Osteoarthritis Score (KOOS)
timeFrame: 12 weeks
measure: Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12
timeFrame: 12 weeks
measure: Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12
timeFrame: 12 weeks
measure: Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12
timeFrame: 12 weeks
measure: Time to Onset of Pain Relief
timeFrame: Baseline to >30% improvement
measure: Average Weekly and Total Consumption of Rescue Medication
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: Flexion Therapeutics
name: Neil Bodick, MD
role: STUDY_DIRECTOR
References: