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Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

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ClinicalTrials.gov Identifier: NCT03378076
Recruitment Status : Completed
First Posted : December 19, 2017
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Brief Summary:
This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Condition or disease Intervention/treatment Phase
Bilateral Knee Osteoarthritis Drug: FX006 32 mg Drug: TAcs 40 mg Phase 2

Detailed Description:

This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA.

Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with IA injections to both knees of either:

  • extended-release FX006 64 mg total dose (approximately 12 patients) or
  • immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on Day 1. Following screening, pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 8, 15, 29, and 43.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)
Actual Study Start Date : December 6, 2017
Actual Primary Completion Date : March 14, 2018
Actual Study Completion Date : March 14, 2018


Arm Intervention/treatment
Experimental: FX006 32 mg
Two intra-articular (IA) injections of FX006 32 mg (total dose of 64 mg)
Drug: FX006 32 mg
Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)
Other Name: Zilretta

Active Comparator: TAcs 40 mg
Two intra-articular (IA) injections of TAcs 40 mg (total dose of 80 mg)
Drug: TAcs 40 mg
Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)
Other Names:
  • Kenalog®-40 Injection
  • Triamcinolone Acetonide Crystalline Suspension (TAcs)
  • TCA-IR 40




Primary Outcome Measures :
  1. Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma [ Time Frame: 43 days ]

    Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma.

    For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations


  2. Incidence of Treatment Emergent Adverse Events [ Time Frame: 43 days ]

    Safety analyses were conducted using the safety population.

    Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE).




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written consent to participate in the study
  • Male or female greater than or equal to 40 years of age
  • Symptoms consistent with OA in both knees for greater than or equal to 6 months prior to Screening (patient reported is acceptable)
  • Currently meets ACR Criteria (clinical and radiological) for OA in both knees
  • Knee pain in both knees for greater than 15 days over the last month (as reported by the patient)
  • Body mass index (BMI) less than or equal to 40 kg/m2
  • Morning serum cortisol result within normal range at Screening (5-23 mcg/dL or 138-635 nmol/dL)
  • Ambulatory and in good general health
  • Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
  • Willing 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 either knee joint
  • Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
  • Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12 months of Screening
  • Presence of surgical hardware or other foreign body in either knee
  • Surgery or arthroscopy of either knee within 12 months of Screening
  • IA treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).
  • IA treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
  • Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
  • Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
  • Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

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): NCT03378076


Locations
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United States, California
LA Biomed at Harbor-UCLA Medical Center
Torrance, California, United States, 90509
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
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Study Director: Scott Kelley, MD Flexion Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Flexion Therapeutics, Inc.:
Study Protocol  [PDF] November 10, 2017
Statistical Analysis Plan  [PDF] March 8, 2018


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Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03378076     History of Changes
Other Study ID Numbers: FX006-2017-012
First Posted: December 19, 2017    Key Record Dates
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flexion Therapeutics, Inc.:
Osteoarthritis
Knee
Corticosteroid
Bilateral
Pain
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
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