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Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT02468583
Recruitment Status : Terminated
First Posted : June 11, 2015
Results First Posted : December 21, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post-traumatic Osteoarthritis of the Knee Drug: FX006 32 mg Drug: TCA IR 40 mg Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: FX006 32mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
 Drug: FX006 32 mg
Experimental
Other Name: Zilretta
Active Comparator: TCA IR 40 mg
Single 1 mL intra-articular (IA) injection Immediate-release formulation
 Drug: TCA IR 40 mg
Comparator
Other Names:
  • Kenalog®-40
  • Triamcinolone Acetonide Crystalline Suspension (TAcs)


Outcome Measures
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Primary Outcome Measures :
  1. Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10 [ Time Frame: 5-10 Weeks ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."


Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 Weeks ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  2. 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 [ Time Frame: 12 Weeks ]
  3. 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 [ Time Frame: 12 Weeks ]
  4. 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 [ Time Frame: 12 Weeks ]
  5. WOMAC A (Pain Subscale) [ Time Frame: 12 weeks ]
    change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

  6. WOMAC A1 (Pain on Walking Question) [ Time Frame: 12 weeks ]
    change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

  7. WOMAC B (Stiffness) [ Time Frame: 12 weeks ]
    change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

  8. WOMAC C (Function) [ Time Frame: 12 weeks ]
    change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

  9. WOMAC (Total): [ Time Frame: 12 weeks ]
    change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

  10. Knee Injury and Osteoarthritis Score (KOOS) [ Time Frame: 12 weeks ]
    change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

  11. Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12 [ Time Frame: 12 weeks ]
  12. Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12 [ Time Frame: 12 weeks ]
  13. Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12 [ Time Frame: 12 weeks ]
  14. Time to Onset of Pain Relief [ Time Frame: Baseline to >30% improvement ]
    Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing >30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline

  15. Average Weekly and Total Consumption of Rescue Medication [ Time Frame: 12 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468583


Locations
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United States, Texas
San Antonio Military Medical Center
San Antonio, Texas, United States, 78234
Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
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Study Director: Neil Bodick, MD Flexion Therapeutics
More Information
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Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02468583    
Other Study ID Numbers: FX006-2014-007
First Posted: June 11, 2015    Key Record Dates
Results First Posted: December 21, 2017
Last Update Posted: August 29, 2018
Last Verified: August 2018
Keywords provided by Flexion Therapeutics, Inc.:
Osteoarthritis
Post-traumatic
Knee
Pain
 Corticosteroid
Intra-articular
Injection
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
FX006
 Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action