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Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT03046446
Recruitment Status : Completed
First Posted : February 8, 2017
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Brief Summary:
This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee

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

Detailed Description:

This study is an open-label, repeat administration design of 32 mg FX006. The study will be conducted in male and female patients ≥ 40 years of age with symptomatic OA of the knee.

Eligible patients will be offered participation to receive an initial intra-articular (IA) injection of FX006 administered to the index knee at Day 1.

Patients who receive an initial injection of FX006 will return at Weeks 4 and 8 before being evaluated at 12, 16, 20 and 24 weeks for repeat administration. At the first evaluation where the patient has been determined to meet repeat administration eligibility criteria, the patient will be eligible to receive a second IA injection of FX006.

Patients who are eligible to receive a second injection will be evaluated for a total of 52 weeks post initial injection at: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52, regardless of the time at which they receive their second injection. In addition, X-rays will be completed at Screening and Week 52 or End of Study (EOS) for assessment of safety.

Patients that do not benefit from the initial treatment as determined by evaluation at Week 12 will complete the study at the Week 12 follow-up visit.

Patients who are not eligible for a second injection of FX006 after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: FX006 32 mg
Single intra-articular injection
Drug: FX006 32 mg
Single intra-articular injection




Primary Outcome Measures :
  1. Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006 [ Time Frame: Up to 52 Weeks ]
    Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE) in patients who received two doses of 32 mg FX006. TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).


Other Outcome Measures:
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Subscale [ Time Frame: 12 Weeks Post Each FX006 Administration ]

    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC A is the independent sub-scale for pain that is comprised of 5 questions.

    WOMAC A was administered at each visit from screening through Week 52/EOS.


  2. WOMAC B Stiffness Subscale [ Time Frame: 12 Weeks Post Each FX006 Administration ]

    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC B is the independent sub-scale for stiffness that is comprised of 2 questions.

    WOMAC B was administered at each visit from screening through Week 52/EOS.


  3. WOMAC C Function Subscale [ Time Frame: 12 Weeks Post Each FX006 Administration ]

    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC C is the independent sub-scale for function that is comprised of 17 questions.

    WOMAC C was administered at each visit from screening through Week 52/EOS.


  4. Knee Injury and Osteoarthritis Outcome Score (KOOS) QOL Subscale [ Time Frame: Up to 12 Weeks Post Each FX006 Administration ]

    KOOS is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored sub-scales: KOOS Pain, KOOS Symptoms, Function in daily living, Function in Sport and Recreation, and knee-related Quality of Life (KOOS QOL). Only KOOS QOL sub-scale (Q1-Q4) was used in this study.

    A Likert scale is used and all items have five possible answer options scored from 0 (No Problem) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. Higher scores indicate a better quality of life.

    KOOS was administered at study visits from BL/Day 1 through week 52.




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
  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
  • Male or female ≥ 40 years of age
  • Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening
  • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
  • Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the index knee based on X-ray performed during Screening
  • Qualifying score for WOMAC A at Screening and Day 1/Baseline
  • Index knee pain for >15 days over the last month (as reported by the patient)
  • Body mass index (BMI) ≤ 40 kg/m2
  • Ambulatory and in good general health
  • Willingness 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 the index knee joint
  • Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
  • Presence of surgical hardware or other foreign body in the index knee
  • Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening
  • IA corticosteroid (investigational or marketed) in index knee within 3 months of Screening
  • IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
  • IV or intramuscular (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 use 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
  • Women of child-bearing potential not using effective contraception or who are pregnant or nursing

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): NCT03046446


Locations
Show Show 17 study locations
Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
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Study Director: Scott Kelley, MD Flexion Therapeutics
  Study Documents (Full-Text)

Documents provided by Flexion Therapeutics, Inc.:
Study Protocol  [PDF] October 16, 2017
Statistical Analysis Plan  [PDF] August 1, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03046446    
Other Study ID Numbers: FX006-2016-011
First Posted: February 8, 2017    Key Record Dates
Results First Posted: October 29, 2019
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Steroid
Intra-articular
Injection
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases