Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

NCT02116972 | Completed Phase 2 Results

• 1 other identifier: FX006-2014-006
• Study Type: interventional
• Target: 310
• Locations: 2 countries
• Sites: 44

Brief Summary

The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; pain; corticosteroid; intra-articular; injection

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo

  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."

  Baseline and Week 12

Secondary Outcomes (3)

• Change From Baseline to Week 12 for WOMAC C (Function Subscale)

  Baseline and Week 12

• Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)

  Baseline and Week 12

• Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores

  Baseline and Weeks 16, 20 and 24

Other Outcomes (9)

• Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria

  Weeks 4, 8 and 12

• Change From Baseline to Week 12 for WOMAC C (Function Subscale)

  Baseline and Week 12

• Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)

  Baseline and Week 12

Study Arms (3)

FX006 16 mg

EXPERIMENTAL

Single 5 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 16 mg

FX006 32 mg

EXPERIMENTAL

Single 5 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 32 mg

Placebo

PLACEBO COMPARATOR

Normal Saline Single 5 mL intra-articular (IA) injection

Drug: Placebo

Interventions

FX006 32 mg DRUG

Single 5 mL IA injection

Also known as: Zilretta

FX006 32 mg

Placebo DRUG

Single 5 mL IA injection

Also known as: Normal Saline

Placebo

FX006 16 mg DRUG

Single 5 mL IA injection

FX006 16 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
• 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 per Screening X-ray
• 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

You may not qualify if:

• Ipsilateral hip OA
• Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
• History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
• History of arthritides due to crystals (e.g., gout, pseudogout)
• History or clinical signs and symptoms of infection in the index joint
• Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification)
• Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
• 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) corticosteroids (investigational or marketed) within 3 months of Screening
• Oral corticosteroids (investigational or marketed) within 1 month of Screening
• Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
• Any other IA investigational drug/biologic within 6 months of Screening
• Prior use of FX006
• Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (44)

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Anniston, Alabama, 36207, United States

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Birmingham, Alabama, 35216, United States

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85023, United States

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Tucson, Arizona, 85704, United States

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Hot Springs, Arkansas, 71913, United States

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Anaheim, California, 92801, United States

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Canoga Park, California, 91303, United States

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El Cajon, California, 92020, United States

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Los Angeles, California, 90036, United States

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North Hollywood, California, 91606, United States

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San Diego, California, 92103, United States

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Stamford, Connecticut, 06905, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33316, United States

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Orlando, Florida, 32825, United States

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Pinellas Park, Florida, 33781, United States

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Tampa, Florida, 33613, United States

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Marietta, Georgia, 30060, United States

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Evansville, Indiana, 47713, United States

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Paducah, Kentucky, 42003, United States

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Wheaton, Maryland, 20902, United States

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New Bedford, Massachusetts, 02740, United States

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Troy, Michigan, 48085, United States

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Kansas City, Missouri, 64114, United States

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Las Vegas, Nevada, 89106, United States

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Albuquerque, New Mexico, 87102, United States

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New York, New York, 10018, United States

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Rochester, New York, 14609, United States

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Raleigh, North Carolina, 27612, United States

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Oklahoma City, Oklahoma, 73112, United States

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Altoona, Pennsylvania, 16602, United States

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Duncansville, Pennsylvania, 16635, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77055, United States

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San Antonio, Texas, 78258, United States

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Victoria, Texas, 77901, United States

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Danville, Virginia, 24541, United States

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Kitchener, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Québec, Canada

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Related Publications (1)

• Conaghan PG, Cohen SB, Berenbaum F, Lufkin J, Johnson JR, Bodick N. Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. Arthritis Rheumatol. 2018 Feb;70(2):204-211. doi: 10.1002/art.40364. Epub 2017 Dec 20.

  PMID: 29088579 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

FX006; Triamcinolone; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Subsequent to completion of clinical studies extensive testing was performed to assess the actual dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg and from FX006 20 mg vial is 16 mg.

Results Point of Contact

• Title: Scott Kelley, VP of Medical Affairs
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Neil Bodick, MD

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 24, 2024
• Results First Posted: March 20, 2018

Record last verified: 2024-01

Locations

US (39); CA (5)