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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.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: FX006 32 mg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Actual Study Start Date : April 24, 2018
Actual Primary Completion Date : November 8, 2019
Actual Study Completion Date : March 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: FX006 32 mg
Single intra-articular (IA) injection of FX006 32 mg
Drug: FX006 32 mg
Extended-release 32 mg FX006 IA injection
Other Name: Zilretta




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 ≥ 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

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): NCT03529942


Locations
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United States, California
TriWest Research Associates, LLC
El Cajon, California, United States, 92020
Biosolutions Research
La Mesa, California, United States, 91942
Dream Team Clinical Research
Pomona, California, United States, 91767
United States, Florida
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States, 33761
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
PMG Research, Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee, United States, 37938
United Kingdom
University of Leeds
Leeds, United Kingdom, LS7 4SA
Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
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Study Director: Scott Kelley, MD Flexion Therapeutics
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Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03529942    
Other Study ID Numbers: FX006-2017-014
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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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
Pain
Intra-articular
Injection
Corticosteroid
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Inflammation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes