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Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529942
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 8, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE April 24, 2018
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Mean standardized change in synovial volume at 6 weeks [ Time Frame: Baseline to Week 6 ]
Mean standardized change from baseline at 6 weeks in synovial volume
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • Mean absolute change in synovial volume at 6 weeks [ Time Frame: Baseline to Week 6 ]
    Mean absolute change (mm^3) from baseline at 6 weeks in synovial volume
  • Mean standardized change in synovial volume at 24 weeks [ Time Frame: Baseline to Week 24 ]
    Mean standardized change from baseline at 24 weeks in synovial volume
  • Mean absolute change in synovial volume at 24 weeks [ Time Frame: Baseline to Week 24 ]
    Mean absolute change (mm^3) from baseline at 24 weeks in synovial volume
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee
Official Title  ICMJE An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Brief Summary This is an open-label study assessing the effect of the administration of a single intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with osteoarthritis (OA) of the knee.
Detailed Description

This is an open-label study assessing the effect of the administration of a single intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with osteoarthritis (OA) of the knee. The study will be conducted in male and female patients who are ≥ 40 years of age.

Eligible patients who provide written consent and meet all entry criteria will undergo initial ultrasound examination and MRI with contrast of the index knee, and then receive a single IA injection of FX006 administered to the index knee at Baseline/Day 1. Patients will return to the clinic at Weeks 6 and 24 for an MRI with contrast of the index knee and other assessments. Patients must also have a blood sample drawn for Estimated Glomerular Filtration Rate (eGFR) testing within 30 days prior to the scheduled MRIs. In addition, a patient questionnaire will be administered and adverse events (AEs) and concomitant medication updates will be collected via telephone at Weeks 12 and 18.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Drug: FX006 32 mg
Extended-release 32 mg FX006 IA injection
Other Name: Zilretta
Study Arms  ICMJE Experimental: FX006 32 mg
Single intra-articular (IA) injection of FX006 32 mg
Intervention: Drug: FX006 32 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2020)
129
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2018)
100
Actual Study Completion Date  ICMJE March 9, 2020
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written consent to participate in the study
  • Male or female ≥ 40 years of age
  • Body mass index (BMI) ≤ 40 kg/m^2
  • 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
  • Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening (patient self-report is acceptable)
  • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
  • Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee based on X-ray performed during Screening (centrally read)

Exclusion Criteria:

  • Any inflammatory arthritis including reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, gout or secondary OA from gout
  • History of infection or crystal disease in the index knee joint
  • Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening
  • Surgery or arthroscopy of the index knee within 12 months of Screening
  • IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
  • IA treatment of the index knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
  • IV or 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 in the index knee 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
  • eGFR results <40 mL/minute
  • Any contraindication to MRI Scanning (e.g., presence of certain ferromagnetic foreign bodies or electronic devices including most cardiac pacemakers, claustrophobia)
  • Known hypersensitivity to any form of radiographic contrast
  • Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529942
Other Study ID Numbers  ICMJE FX006-2017-014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Flexion Therapeutics, Inc.
Study Sponsor  ICMJE Flexion Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Scott Kelley, MD Flexion Therapeutics
PRS Account Flexion Therapeutics, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP